HANDLING OF CHANGE CONTROL
Change Control: Review, evaluation, approval and monitoring of changes to processes, procedures, specifications, analytical methods, vendors, machines, facilities and utilities. The change can be permanent or temporary.
Permanent Change: Any planned introduction, addition, deletion or modification of Manufacturing Facility, Equipment, Utilities, Manufacturing Process, Material/Product, Specifications, and Test Methods or Operating Procedures that impacts quality or regulatory requirements, which are permanent in nature and not for a specific number of instances or time period.
SCOPE CHANGE CONTROL:
This SOP shall be followed at all the manufacturing sites and applicable to changes related to Manufacturing Facilities, Procurements, Warehousing, Distribution, Process Equipment, Utilities, Manufacturing Processes, Materials/Products, Specifications, Test Methods, Operating Procedures and Corporate Procedures.
RESPONSIBILITY:
Initiator:
Change Initiator shall raise the change control in consultation with HOD (Head of the initiating department).
Shall ensure that there is adequate justification to support the changes.
Shall ensure that supporting documents are submitted/available.
Shall be responsible for follow-up of the entire change control process which includes monitoring / completeness of implementation of action plans in a timely manner.
HOD (Head of the initiating department):
Shall be responsible for reviewing the change in terms of necessity, benefits, workload, effectiveness, viability and regulatory compliance.
Shall ensure the adequacy and accuracy of the justification and supporting documentation.
Shall ensure timely implementation of approved changes and associated action plans.
Shall assess the review requirement / impact assessment from the cross functional team and ensure the review from the concerned departments.
Shall propose the action plan.
Shall ensure entire change control process which includes monitoring/completeness of implementation of action plans in a timely manner.
Shall be able to approve, return and drop the proposed change.
Quality Assurance:
Quality Assurance shall be responsible for review of change control.
Shall assess the requirement for Additional Review / Comments /impact assessment/ action plans from the cross functional team.
Shall be able to approve, return and drop the proposed change.
Evaluator(s) / Other Departments: Head of each concerned department or his/her designee shall be responsible for impact assessment and to identify the actions required for implementation of change, if required.
Environment, Health and Safety (EHS): Head of EHS or his/her designee shall be responsible to evaluate, comment and to identify actions required for implementation of changes on the impact of the change on environment, health and safety.
Regulatory Affairs (RA):
Head RA/Designee shall be responsible to review and comment on the proposed change for regulatory impact.
Shall review the Change implementation and closure.
Shall communicate with the regulatory authorities wherever applicable and advise plant on the same.
Shall propose the action plan(s), if required.
Shall provide decision on proposed change i.e. Approved / Not Approved.
Head/Designee-Quality Assurance:
Head/Designee-Quality Assurance of respective sites shall responsible for change impact assessment, review, comments and decision of proposed change.
Shall assess the requirement for Additional Review / Comments / impact assessment/ action plans from the team.
Shall classify the change as Major or Minor.
Shall ensure to assign the actions required from the concerned persons.
Shall provide decision on proposed change i.e. Approved / Not Approved.
Shall review / comment on proposed change implementation and closure.
Shall communicate to customers or take customer approval, wherever applicable.
Shall ensure timely closure of change control.
DEFINITION:
Change Control: Review, evaluation, approval and monitoring of changes to processes, procedures, specifications, analytical methods, vendors, machines, facilities and utilities. The change can be permanent or temporary.
Permanent Change: Any planned introduction, addition, deletion or modification of Manufacturing Facility, Equipment, Utilities, Manufacturing Process, Material/Product, Specifications, and Test Methods or Operating Procedures that impacts quality or regulatory requirements, which are permanent in nature and not for a specific number of instances or time period.
Temporary Change: A change from the approved document, system or procedure which can be allowed for a specific time period or specific number of instances as approved by Quality Assurance shall be termed as temporary change.
Minor Change: A change that does not have any significant impact on the quality, safety and efficacy or reliability of a product.
Major Change: A change that can have a significant impact on the quality, safety and efficacy or reliability of a product or have a significant impact on the critical quality attributes of a process, material, product, procedure or equipment.
QAMS: QAMS is an electronic system used for Quality Assurance Management System documentation initiation, execution, review and approval (e.g. Change Control Permanent and Change Control Temporary).
PROCEDURE:
This change control procedure shall not be applicable for periodic revision of SOP without any change in content.
Changes related to computerized systems shall be assessed as per the approach defined in SOP “Change Management for Computerized Systems”.
Change Control request shall be raised by initiator wherever need for changes arise, based on the nature of changes i.e. Change Control Permanent or Change Control Temporary.
Procedure for Change Control Permanent in QAMS: Users shall have authorizations applicable to execute activities in QAMS. For ‘Change Control Permanent’ workflow.
Initiation: The person initiating the change shall log in QAMS. The initiator shall fill the applicable information in ‘Change Control Permanent’ form in QAMS.
Select Unit Item Value: Location & Department shall appear by default.
In case, the user is authorized in more than one departments, the default department shall displayed based on the selection at initiating department field.
Issue Code: This shall be default-field used for generation of unique identification number of Change Control Permanent.
Reference: Initiator shall select the reference as ‘Yes’, In-case any history/reference which needs to be referred in this change control else select option ‘No’.
Referred issue(s): If ‘Reference’ is selected as ‘Yes’, select the respective reference document number from the reference list (If required and available in QAMS).
Division: Initiator shall assess the applicability of change & select the appropriate division (‘Formulation’ / ‘API & Formulation’ / ‘API’) from the drop down menu list.
Initiating Department: Initiating department shall be displayed by default.
In case user is authorized in more than one department for initiating of change control, same shall be selected from drop down menu list.
Date of Initiation: Initiation date shall be displayed by-default.
Target Date of Closure: Target date of closure shall be displayed by default.
Target date of closure shall be considered as 90 working days from the date of initiation (In line with system defined holiday calendar).
However, target date of closure can be assigned more than 90 working days with appropriate justification.
Remark(s) / Reason(s): This field shall be mandatory in case of change in ‘Target Date of Closure’ from system default date and appropriate justification shall be mentioned in this field.
Market: Based on the applicability of change, initiator shall select market from the drop down menu list. Multiple options can be selected.
If change control is not related to any market select “Not Applicable”. If change control is not related to listed markets then select “Others” and same shall be mentioned in “Others” field.
Customer: Based on the applicability of change, initiator shall select customer from the drop down menu list. Multiple options can be selected. If change is not related to listed customer then select “Others” and same, shall be mentioned in “Others” field. Selection of customer is not mandatory incase change is not customer specific.
Change related To: As per applicability select the appropriate option from drop down menu list i.e. ‘Product / Material’ / ‘Equipment’ /’Document’ I ‘Facility’ / ‘Other’ / ‘Computerized System’ (In-case product/material/equipment code is not available same shall be defined in “Others” field). Multiple options can be selected.
Product / Material: This field is mandatory, if ‘Product / Material ‘selected in field ‘Change related To’. All finished product, Raw/ Packing Material, Intermediates, Solvents etc. shall be picked-up in “Product / Material” field from Product/Material master list.
Product/Material master shall be uploaded to QAMS from SAP. In-case of SAP failure, same shall be uploaded to QAMS manually. QA shall approve product master creation in QAMS.
Equipment: This field is mandatory, if ‘Equipment’ selected in field ‘Change Related To’. The initiator shall select the equipment/
Instrument details under “Equipment” field from equipment master list. Equipment / Instrument master shall be uploaded to QAMS manually.
QA shall approve equipment creation in QAMS.
Document: This field is mandatory, if ‘Document’ selected in field ‘Change Related To’. Initiator shall fill the document details as required in this field.
Facility: This field is mandatory, if ‘Facility’ selected in field ‘Change Related To’. Initiator shall fill the facility details as required in this field.
Others: This field is mandatory, if ‘Others’ and / or ‘Computerized System’ selected in field ‘Change Related To’. Initiator shall fill the other/ computerized system details as required in this field.
Stage: Based on the proposed change select the applicable stage from the drop down menu list (e.g. Blending, Compression, Hydrolysis, Milling, Distillation etc.), If change is not related to any processing stage select “Not Applicable”. If change is not related to listed stages then select “Others” and same shall be mentioned in “Others” field.
Current Practice: Initiator shall describe the current practice related to Product Material/Equipment, Document, Facility/others being followed and shall ensure that all relevant current practices are mentioned in the given field.
Proposed Change: Initiator shall describe the details of the changes proposed and shall ensure that all proposed changes are mentioned in the given field. Proposed changes shall be mentioned in the sequential manner in line with current practice. Comparison of current practice and proposed changes shall be given, if required.
Initiator-File attachments (if any): Initiator shall attach the applicable files (If required).The document attached in this field shall be non-editable.
Justification for Proposed Change: Initiator shall mention the justifications in the sequential manner in line with proposed changes.
Supporting Data / References List of Attachments: Wherever required, initiator shall mention the details of any supporting data / reference(s) or list of technical findings as available to support the proposed change in this field.
SOP / Specification / BMR / BPR: If the proposed change is related to SOP/Specification/BMR/BPR, option “Yes” shall be selected. If the proposed change is not related to SOP/Specification/BMR/BPR, option “No” shall be selected.
Attachment(s): This field is mandatory, if option “Yes” selected in the field SOP/Specification/BMR/BPR. Initiator shall attach the draft copy of relevant files(s) as applicable. The document attached here shall be editable and change history shall be visible ‘through track changes. If SOP is in non-editable file format (e.g. scan, pdf etc.) then attach the same at “Initiator-File attachments (if any)”.
Initiator shall submit the change control to 1-HOD/Designee for further review and comments. I-HOD shall get a system generated alert on mail.
After submission of the change control, system shall generate a provisional issue code with prefix “PROV”.
In case of re-initiation, initiator shall correct the necessary details and submit the change control to HOD/ Designee by clicking on ‘submit ‘button with reason and remarks. I-HOD/ Designee shall get a system generated alert on e-mail.
Review of Change Control by HOD / Designee: HOD / Designee shall login to QAMS.
HOD Review Comments: HOD/ Designee shall review the change control and shall mention the comments on proposed change.
Action Plan Proposal(s) required: HOD / Designee shall take decision on requirement of action plan and select appropriate option (Yes/No).
Proposed Action Plan(s): This field shall be mandatory, if option “Yes” selected in the field “Action Plan Proposal(s) Required”. HOD/ Designee shall select the action plan from the drop down menu list (e.g. BPR/SOP/Specification/BMR etc.) based on review and proposed changes. Multiple actions can be proposed.
HOD shall assign the task (Plan description) to the In-charge department (department responsible for that activity) along with In-charge user group (concerned department head responsible for that activity). Auto generated target date shall appear in the system by calculating 70 working days from the date of initiation (In line with system defined holiday calendar). Target date of action plans may be extended up to issue target date by providing justification/reasons and accordingly submit the action plan proposal(s).
Department(s) required to Provide Impact Assessment / Evaluation: HOD / Designee shall assess the review requirement/impact assessment from the cross functional team and select the concerned departments for the same from the drop down menu list for further review. Wherever applicable required site head comments shall be received through departmental review. Guidance for identifying the department that are required to review the change control and provide impact assessment is given below.
File Attachments (if any) (I-HOD): HOD / Designee shall attach appropriate documents, wherever required.
Decision: HOD / Designee shall decide and select the appropriate option from “Approve/Return/Drop” option. Upon selection of option “Approve”, change control shall be forwarded to Quality assurance for further action. Upon selection of option “Return” change control shall be returned to the initiator for further correction. Upon selection of option “Drop” the change control shall be terminated at that instance.
Remark(s) / Reason(s): In-case of return or drop, HOD / Designee shall provide appropriate reason(s) /remark(s).
On submitting the change control to Quality Assurance for further review. Quality Assurance shall get a system generated alert mail.
Quality Assurance Review Comments: Quality Assurance shall login QAMS.
QA Review Comments: Quality Assurance shall review and comment on the proposed change.
Additional Review / Comments – Other Departments (if required):
Quality Assurance shall review the list of departments identified by department head for review / impact assessment & add additional departments from the drop down menu list (wherever required).
File Attachments (if any) (QA): Quality Assurance shall attach appropriate documents, wherever required.
Quality Assurance shall take decision to “Approve/Return/Drop” the proposed change and select the appropriate option. Upon selection of “Approve” option, change control shall be forwarded to concerned departments. Upon selection of “Return” option, change control shall be returned to the initiator for further correction. Upon selection of “Drop” option change control shall be terminated at that instance.
Submit the change control and concerned department shall get a system generated alert on mail.
On approval of Change Control Permanent, system shall automatically generate a unique issue code.
Other Department (s) Comments: Other departments Head/Designee shall login to QAMS.
Comments: Head/Designee-Other departments shall review the proposed change and shall provide the comment based on the impact of the change and actions required to be taken for evaluation or for implementation.
File attachments (If any): Head/Designee-Other departments shall attach appropriate documents, wherever required.
Head/Designee-Other departments shall submit the change control.
During the assessment of change(s), if required, QA may coordinate with other relevant department personnel and call for a meeting to discuss the change and identify the action plan.
After review of all the concerned departments change control shall be automatically forwarded to Regulatory Affairs. Head Regulatory Affairs /designee shall get a system generated alert on mail.
Regulatory Affairs Review: Regulatory Affairs Head/Designee shall login QAMS.
Review Comments: Regulatory Affairs Head/Designee shall review and comment on the proposed change.
Action Plan Proposal(s) required: Based on the impact on regulatory requirement/submission, Regulatory affairs Head/Designee shall take decision on requirement of action plan and select appropriate option (Yes/No).
Proposed Action Plan(s): If Yes, Regulatory Affairs Head/Designee shall identify the action plan and select the appropriate option from the drop-down menu list (Submission requirements, Notification to regulatory agency and others).
Decision on Change Control: Regulatory Affairs Head/Designee shall take the decision on change control as “Approved / Not Approved” and select the appropriate option. Upon selection of option “Approved”, change control shall be forwarded to Head/Designee Quality Assurance. In-case option selected as “Not Approved”, change control shall be available at “Closure Initiation”. Initiator & HOD shall get a system generated alert on mail. Change Control proposal that is not acceptable shall be discussed with the initiator and subsequently “Not Approved” with reasons.
RA shall ensure that the changes are being reviewed as per the respective country regulatory and product file requirement.
Remark(s)/Reason(s): Regulatory Affairs Head/Designee shall specify the reason for selection of option “Not-Approved”.
File Attachments (if any): Regulatory Affairs Head/Designee shall attach appropriate documents, wherever required.
QA Decision: Head/Designee-Quality Assurance shall login QAMS.
Review Comments: Head/Designee-Quality Assurance shall review and comment on the proposed change.
Head/Designee-Quality Assurance shall have the authorization to revisit/negate the comments of other departments and proposed actions.
If the actions given by other departments need a new task generation same shall be ensured by Head/Designee-Quality Assurance.
Category: Depending upon the impact of change, Head/Designee Quality Assurance shall categorize the change control as “Major/Minor”. Quality Risk Assessment shall be mandatory, if change control categorized as “Major” else it is optional for execution. For categorization of Change Control Permanent.
Quality Risk Assessment (QRA): Head/Designee-Quality Assurance shall initiate the proposal for QRA (if required) and assign the task (Plan description) to the In-charge department (department responsible for that activity) along with In-charge user group (concerned department head responsible for that activity). ORA action plan shall be submitted to respective personnel/group for further execution.
Additional Action Plan Proposal(s) Required: Head/Designee Quality Assurance shall take decision on requirement of additional action plan (if required) and select appropriate option (Yes/No).
Proposed Action Plan(s): This field is mandatory, if option “Yes” selected in the field “Additional Action Plan Proposal(s) Required”.
Head/Designee-Quality Assurance shall identify the action plan and select the appropriate option from the drop-down menu (e.g. BPR,
Other). Head/Designee-Quality Assurance shall also initiate the action plan recommended by, other departments.
Decision on Change Control: Based on the review, Head/Designee Quality Assurance shall take the decision on change control and select the appropriate option from “Approved/ Not approved”.
Upon selection of “Approved” option, action plan shall be released for acceptance by in-charge group (concerned department head responsible for that activity).
In case, ‘Customer Approval’ is required then proposed action plan shall be released for acceptance based on the ‘Customer Decision’ under ‘Customer Approval’ work item. Whereas, ORA action plan shall be available for execution in parallel to ‘Customer Approval’.
Change Control proposal that is not acceptable shall be discussed with the initiator and subsequently “Not Approved” with reasons. Upon selection of “Not Approved” option, change control shall be available at “Closure Initiation”. Initiator/ HOD/In-charge action plan shall receive system generated alert on mail.
Customer Approval Required: This field shall be applicable only when ‘Decision on Change Control’ is selected as ‘Approved’.
Head/Designee-Quality Assurance shall take decision and evaluate the requirement of customer approval. Accordingly, appropriate option (Yes/No) shall be selected.
Customer Approval: This field is mandatory, if option “Yes” selected in the field “Customer Approval Required”. Head/Designee-Quality Assurance shall select the default work item from the pop-up.
Customer Notification Required: This field shall be applicable when ‘Decision on Change Control’ is selected as ‘Approved’ and Customer Approval is selected as ‘No’. Head/Designee-Quality Assurance shall take decision and ~valuate the requirement of customer notification.
Accordingly, appropriate option (Yes/No) shall be selected.
Proposed Action Plan(s): This field is mandatory, if option “Yes” selected in the field “Customer Notification Required”. Head/Designee Quality Assurance shall select the ‘Notification Action’ and assign to applicable In-charge.
Remark(s)/Reason(s): Head/Designee-Quality Assurance shall specify the reason for selection of option “Not-Approved” at ‘Decision on Change Control’.
File Attachments (if any): Head/Designee-Quality Assurance shall attach appropriate documents, wherever required.
Customer Approval (Wherever Applicable):
Customer approval work item shall be generated whenever selected at ‘QA Decision’ and available with Head/Designee-Quality Assurance at ‘QA Decision’ block.
Head/Designee-Quality Assurance shall login QAMS.
Comments: Head/Designee-Quality Assurance shall enter the review and comment received on the proposed change from customer.
Customer Details: Head/Designee-Quality Assurance shall specify the customer details e.g. Name of Customer, Person contacted etc.
Customer Decision: Head/Designee-Quality Assurance shall select the appropriate option from “Accepted / Not accepted” as received from respective customer on proposed change.
Upon selection of “Accepted” option, action plan shall be released for acceptance by in-charge group (concerned department head responsible for that activity).
In case, QRA action plan is accepted and under execution then selection of “Not Accepted” option shall be restricted till QRA action plan not closed/force closed.
Upon selection of “Not Accepted” option, change control shall be available at “Closure Initiation”. Initiator/I-HOD/In-charge action plan shall receive system generated alert on mail.
File Attachments (if any): Head/Designee-Quality Assurance shall attach appropriate documents, wherever required.
Action Plan Proposal (Acceptance/Authorization):
After approval of change control action plan shall be available for further action by in-charge group (concerned department head responsible for that activity). Respective person shall login to QAMS.
In-charge group shall review and take decision on acceptance of action plan and select appropriate option (Yes/No).
If In-charge group selects “Yes” then action plan shall be available for allocation of work.
If In-charge group selects “No” then action plan shall be escalated to Quality Assurance for re-consideration, Quality Assurance shall take appropriate decision from available options i.e. “Yes/No/Return”.
Upon selection of “Yes” option, action plan shall be available for allocation of work for in-charge group. Upon selection of “No” option, action plan shall be terminated. Upon selection of “Return” option, action plan shall be returned to in-charge group for re-consideration.
After acceptance/authorization confirmation, Unique Number (Plan Code) shall be generated by the system automatically.
For ‘Action Plan’, Unique Number (Plan Code) shall be as <Issue Code/MB>. Where, Issue code: Stands for document number.
For Effectiveness/Monitoring Plan, Unique Number of respective action plan.
Action Plan(s) Allocation:
Based on the relevance of work, in-charge group shall allocate action plan to the user/group for execution by selecting “Allocate New Work
Form” through the drop-down menu list.
To assign the work in-charge group shall fill the applicable details in “Work Item Form”.
Work item ID: Unique Number shall be generated by the system automatically.
Plan Code: Unique Number (Plan Code) of respective plan (Action & Effectiveness/monitoring Plan).
Work Type: Based on selected action plan, “Work Type” shall be displayed by-default.
Activity Details Form: Action plan in charge shall select the required form based on applicability from the drop-down menu list.
Work Allocation: Action plan in charge shall assign work to “Specific User” or “Specific Group” based on applicability through drop-down menu list.
Work Dependency: Action plan in charge shall identify other work dependency on the work for completion or initiation e.g. second activity
cannot be initiated till the completion of first. Action plan in charge shall select the applicable work item from the drop-down menu list. Closed work item shall not be available for dependency.
Start Date: It shall be displayed by-default based on the allocation of work.
Target Date: It shall be displayed by-default based on action plan target date.
Work Description: Action plan in charge shall mention the details of work to be executed.
In-case, additional work is required for action plan, in-charge action plan shall allocate new work against the same action plan.
Action Plan(s) Execution:
Initiation: After completion of allocated work the user shall update the status of the executed work and shall attach file (if any).
Allocated work shall follow the pre-defined approval workflow (if applicable), based on the type of work selected.
Approval: If approval is applicable (by-default), then select the relevant hyperlink under the column “Work Item ID”. The approver shall review the action plan and comment on the basis of review. Approver shall take the decision to Approve/Return the action plan work item. If returned, work item shall go back to initiator for re-consideration. If approved from all levels of approvers (based on action plan type), action plan shall be closed. System shall generate the alert e-mail automatically to the concerned group.
Action Plan(s) Closure:
In-charge action plan (concerned department head responsible for that activity) shall review & verify the completion of allotted action plan related work items and comment.
In-charge action plan shall evaluate the need for post implementation review i.e. Effectiveness/ Monitoring (E/M) of the changes.
In-case allocated work items are closed and no additional work item required within the action plan then in charge-action plan shall close the action plan.
In-case any proposed action plan is not required to be executed, then in-charge of action plan shall close the action plan forcefully with justification.
Action plans shall be mandatory to close before closure initiation.
Closure Initiation:
Initiator:
Initiator shall verify & ensure the completion of all change related activities and initiate the closure of change control. Initiator shall mention the implementation status/references in field “Implementation Details”.
If required, initiator shall select reference change control in “Reference Change Control No. (if any)”. If reference Change Control is not available in QAMS reference list for selection then reference Change Control no. shall be mentioned in field “Implementation Details”.
Initiator shall attach file attachment (if required) in field “Initiator-File Attachments (if any)” and shall submit the change control closure to HOD for further review. System shall generate alert mail communication to HOD.
Final Closure:
HOD:
HOD shall review the closure details. Based on the review, HOD shall mention comments in field “HOD Comments” and attach the file
(If required) in field “File Attachments (if any) (HOD)”.
HOD shall ensure the completion of all change related activities.
Upon review, HOD shall take decision to “Approve/Return” the change control closure.
If returned, change control closure shall go back to closure initiator for re-consideration and system shall generate alert mail communication to change control initiator.
If approved, change control closure shall be forwarded to Head RA/Designee for further review and system shall generate alert mail communication to Head RA/designee.
Regulatory Affairs (RA):
Head RA/designee shall review the closure details. Based on the review, Head RA/designee shall mention comments in field “RA Comments” and attach the file (if required) in field “File Attachments (if any) (RA)”.
Upon review, Head RA/designee shall take decision to “Approve/Return” the change control closure.
If returned, change control closure shall go back to closure initiator for re-consideration and system shall generate alert mail communication to change control initiator.
If approved, change control closure shall be forwarded to Quality Assurance for further review and system shall generate alert mail communication to Quality Assurance group.
Quality Assurance:
Quality Assurance shall review the closure details. Based on the review, Quality Assurance shall mention comments in field “QA Comments” and attach the file (if required) in field “File Attachments (if any) (QA)”. Quality Assurance shall select the status of proposed change as “Implemented / partially implemented / Not Implemented” from drop down menu list at “Decision” field.
Quality Assurance shall also evaluate the need for E/M plan i.e. Effectiveness/ Monitoring (E/M) of the changes.
Quality Assurance shall take decision to “Approve/Return” the change control closure based on review.
If returned, change control closure shall go back to closure initiator for re-consideration and system shall generate alert mail communication to change control initiator.
If approved, change control shall be closed and system shall generate alert mail communication to change control initiator, HOD and QA.
Procedure for Change Control Temporary in QAMS: Users shall have authorizations applicable to execute activities in QAMS. For ‘Change Control Temporary’ workflow.
Initiation: The person initiating the change shall log in QAMS. The initiator shall fill the applicable information in ‘Change Control Temporary’ form in QAMS.
Select Unit Item Value: Location & Department shall appear by default.
In case, the user is authorized in more than one departments, the default department shall displayed based on the selection at initiating department field.
Issue code: This shall be default-field used for generation of unique identification number of Change Control Temporary.
Reference: Initiator shall select the reference as ‘Yes’, In-case any history/reference which needs to be referred in this change control else select option ‘No’.
Referred lssue(s): If ‘Reference’ is selected as ‘Yes’, select the respective reference document number from the reference list (If required and available in QAMS).
Division: Initiator shall assess the applicability of change & select the appropriate division (‘Formulation’ / ‘API & Formulation’ / ‘API’) from the drop down menu list.
Initiating Department: Initiating department shall be displayed by default.
In case user is authorized in more than one department for initiating of change control, same shall be selected from drop down menu list.
Date of Initiation: Initiation date shall be displayed by-default.
Target Date of Closure: Target date of closure shall be displayed by default.
Target date of closure shall be considered as 90 working days from the date of initiation (In line with system defined holiday calendar).
However, target date of closure can be assigned more than 90 working days with appropriate justification.
Remark (s} / Reason (s}: This field shall be mandatory in case of change in ‘Target Date of Closure’ from system default date and appropriate justification shall be mentioned in this field.
Market: Based on the applicability of change, initiator shall select market from the drop down menu list. Multiple options can be selected.
If change control is not related to any market select “Not Applicable”. If change control is not related to listed markets then select “Others” and same shall be mentioned in “Others” field.
Customer: Based on the applicability of change, initiator shall select customer from the drop down menu list. Multiple options can be selected. If change is not related to listed customer then select “Others” and same shall be mentioned in “Others” field. Selection of customer is not mandatory incase change is not customer specific.
Change Related To: As per applicability select the appropriate option from drop down menu list i.e. ‘Product / Material’ / ‘Equipment’ /’Document’ / ‘Facility’ / ‘Other’ / ‘Computerized System’ (In-case product material/equipment code is not available same shall be defined in “Others” field). Multiple options can be selected.
Product / Material: This field is mandatory, if ‘Product / Material’ selected in field ‘Change Related To’. All finished product, Raw/Packing Material, Intermediates, Solvents etc. shall be picked-up in “Product / Material” field from Product/Material master list.
Product Material master shall be uploaded to QAMS from SAP. In-case of SAP failure, same shall be uploaded to QAMS manually. QA shall approve product master creation in QAMS.
Batch / Lot No(s) (if any): Initiator shall select Batch/Lot affected by the change control (as applicable) from Batch master list. Batch master shall be uploaded to QAMS from SAP In-case of SAP failure same shall be uploaded to QAMS manually. QA shall approve batch master creation/modification in QAMS.
Equipment: This field is mandatory, if ‘Equipment’ selected in field ‘Change Related To’. The initiator shall select the equipment Instrument details under “Equipment” field from equipment master list.
Equipment / Instrument master shall be uploaded to QAMS manually.
QA shall approve equipment creation/modification in QAMS.
Document: This field is mandatory, if ‘Document’ selected in field ‘Change Related To’. Initiator shall fill the document details as required in this field.
Facility: This field is mandatory, if ‘Facility’ selected in field ‘Change Related To’. Initiator shall fill the facility details as required in this field.
Others: This field is mandatory, if ‘Others’ and / or ‘Computerized System’ selected in field ‘Change Related To’. Initiator shall fill the other/ computerized system details as required in this field.
Stage: Based on the proposed change select the applicable stage from the drop down menu list (e.g. Blending, Compression, Hydrolysis, Milling, Distillation etc.), If change is not related to any processing stage select “Not Applicable”. If change is not related to listed stages then select “Others” and same shall be mentioned in “Others” field.
Current practice: Initiator shall describe the current practice related to Product/Material/Equipment/Document/Facility/others being followed.
Ensure that all relevant current practices are mentioned in the given field.
Proposed change: Initiator shall describe the details of the changes proposed and shall ensure that all proposed changes are mentioned in the given field. Proposed changes shall be mentioned in the sequential manner in line with current practice. Comparison of current practice and proposed changes shall be given, if required.
Initiator-File attachments (if any): Initiator shall attach the applicable files (If required).The document attached in this field shall be noneditable.
Justification for proposed change: Initiator shall mention justifications in the sequential manner in line with proposed changes.
Supporting data/reference/list of attachments: wherever required, initiator shall mention the details of any supporting data / reference(s) or list of technical findings as available to support the proposed change in this field.
SOP / Specification / BMR / BPR: If the proposed change is related to SOP/Specification/BMR/BPR, option “Yes” shall be selected. If the proposed change is not related to SOP/Specification/BMR/BPR, option “No” shall be selected.
Attachments: This field is mandatory, if option “Yes” selected in the field ‘SOP/Specification/BMR/BPR’. Initiator shall attach the draft copy of relevant files(s) as applicable. The document attached here shall be editable and change history shall be visible through track changes. If SOP is in non-editable file format (e.g. scan, pdf etc.) then attach the same at “Initiator-File attachments (if any)”.
Initiator shall submit the change control to HOD for further review and comments. HOD spall get a system generated alert on mail.
After submission of the change control, system shall generate a provisional issue code with prefix “PROV”.
In case of re-initiation, initiator shall correct the necessary details and submit the change control to HOD/ Designee by clicking on ‘submit’
button with reason and remarks. HOD/ Designee shall get a system generated alert on e-mail.
Review of HOD: IHOD/ Designee shall login QAMS.
HOD Review Comments: HOD/ Designee shall review the change control and shall mention the comments on proposed change.
Action Plan Proposal(s) Required: HOD / Designee shall take decision on requirement of action plan and select appropriate option (Yes/No).
Proposed Action Plan(s): This field shall be mandatory, if option “Yes” selected in the field “Action Plan Proposal(s) Required”. HOD/Designee shall select the action plan from the drop down menu list (e.g. BPR/SOP/Specification/BMR etc.) based on review. Multiple actions can be proposed.
HOD shall assign the task (Plan description) to the In-charge department (department responsible for that activity) along with In-charge user group (concerned department head responsible for that activity). Auto generated target date shall appear in the system by calculating 70 working days from the date of initiation (In line with system defined holiday calendar). Target date of action plans may be extended up to issue target date by providing justification/reasons and accordingly submit the action plan proposal(s).
Department(S) Required to Provide Impact Assessment / Evaluation: HOD / Designee shall assess the review requirement/impact assessment from the cross functional team and select the concerned departments for the same from the drop down menu list for further review. Wherever applicable required site head comments shall be received through departmental review. Guidance for identifying the department that are required to review the change control and provide impact assessment.
Decision: HOD / Designee shall decide and select the appropriate option from “Approve/Return/Drop” option. Upon selection of option “Approve”, change control shall be forwarded to Quality assurance for further action. Upon selection of option “Return” change control shall be returned to the initiator for further correction. Upon selection of option “Drop” the change control shall be terminated at that instance.
Remark(s) / Reason(s): In-case of return or drop, HOD / Designee shall provide appropriate reason(s) /remark(s).
Submit the change control to Quality Assurance for further review.
Quality Assurance shall get a system generated alert mail.
Quality Assurance Review Comments: Quality Assurance shall login QAMS.
QA Review Comments: Quality Assurance shall review and comment on the proposed change.
Additional Review / Comments – Other Departments (if required):
Quality Assurance shall review the list of departments identified by department head for review / impact assessment & add additional departments from the drop down menu list (if required).
Quality Assurance shall take decision to “Approve/Return/Drop” the proposed change and select the appropriate option. Upon selection of
“Approve” option, change control shall be forwarded to concerned departments. Upon selection of “Return” option, change control shall be returned to the initiator for further correction. Upon selection of “Drop” option change control shall be terminated at that instance.
Submit the change control and concerned department shall get a system generated alert on mail.
On approval of Change Control Temporary system shall automatically generate a unique issue code.
Other Department (s) Comments: Other departments Head/ Designee shall login QAMS.
Comments: Head/Designee-Other departments shall review the proposed change and shall provide the comment based on the impact of the change and actions required to be taken for evaluation or for implementation.
File attachments (If any): Head/Designee-Other departments shall attach appropriate documents, wherever required.
Head/Designee-Other departments shall submit the change control.
During the assessment of change(s), if required, QA may coordinate with other relevant department personnel and call for a meeting to discuss the change and identify the action plan.
After review of all the concerned departments change control shall be automatically forwarded to regulatory affairs. Head Regulatory affairs
/designee shall get a system generated alert on mail.
Regulatory Affairs Review: Regulatory Affairs Head/ Designee shall login to QAMS.
Review Comments: Regulatory Affairs Head/ Designee shall review and comment on the proposed change.
Action Plan Proposal(s) required: Based on the impact on regulatory requirement/submission, Regulatory affairs Head/Designee shall take decision on requirement of action plan and select appropriate option (Yes/No).
Proposed Action Plan(s): If Yes, Regulatory affairs Head/Designee shall identify the action plan and select the appropriate option from the drop-down menu list (Submission requirements, Notification to regulatory agency and others).
Decision on Change Control: Regulatory affairs Head/Designee shall take the decision on change control as “Approval/Not Approved” and select the appropriate option. Upon selection of option “Approved”, change control spall be forwarded to Head/Designee-Quality Assurance. In-case option selected as “Not Approved”, change control shall be available at “Closure Initiation”. Initiator & HOD shall get a system generated alert on mail. Change Control proposal that is not acceptable shall be discussed with the initiator and subsequently “Not Approved” with reasons. RA shall ensure that the changes are being reviewed as per the respective country regulatory and product file requirement.
Remark(s)/Reason(s): Regulatory affairs Head/Designee shall specify the reason for selection of option “Not-Approved”.
File Attachments (if any): Regulatory affairs Head/Designee shall attach appropriate documents, wherever required.
QA Decision: Head/Designee-Quality Assurance shall login QAMS.
Review Comments: Head/Designee-Quality Assurance shall review and comment on the proposed change.
Head/Designee-Quality Assurance shall have the authorization to revisit/negate the comments of other departments and proposed actions.
If the actions given by other departments need a new task generation same shall be ensured by Head/Designee-Quality Assurance.
Category: Depending upon the impact of change, Head/Designee Quality Assurance shall categorize the change control as “Major/Minor”. Quality Risk Assessment shall be mandatory, if change control categorized as “Major” else it is optional for execution. For categorization of Change Control Permanent.
Quality Risk Assessment (QRA): Head/Designee-Quality Assurance shall initiate the proposal for QRA (if required) and assign the task (Plan description) to the In-charge department (department responsible for that activity) along with In-charge user group (concerned department head responsible for that activity). QRA action plan shall be submitted to respective personnel/group for further execution.
Additional Action Plan Proposal(s) Required: Head/Designee Quality Assurance shall take decision on requirement of additional action plan (if required) and select appropriate option (Yes/No).
Proposed Action Plan(s): This field is mandatory, if option “Yes” selected in the field “Additional Action Plan Proposal(s) Required”
Head/Designee-Quality Assurance shall identify the action plan and select the appropriate option from the drop-down menu (e.g. BPR, Other). Head/Designee-Quality Assurance shall also initiate the action plan recommended by other departments.
Decision on Change Control: Based on the review, Head/Designee Quality Assurance shall take the decision on change control and select the appropriate option from “Approved / Not approved”.
Upon selection of “Approved” option, action plan shall be released for acceptance by in-charge group (concerned department head responsible for that activity).
In case, ‘Customer Approval’ is required then proposed action plan shall be released for acceptance based on the ‘Customer Decision’ under ‘Customer Approval’ work item. Whereas, QRA action plan shall be available for execution in parallel to ‘Customer Approval’.
Change Control proposal that is not acceptable shall be discussed with the initiator and subsequently “Not Approved” with reasons. Upon selection of “Not Approved” option, change control shall be available at “Closure Initiation”. Initiator/HOD/In-charge action plan shall receive system generated alert on mail.
Customer Approval Required: This field shall be applicable only when ‘Decision on Change Control’ is selected as ‘Approved’.
Head/Designee-Quality Assurance shall take decision and evaluate the requirement of customer approval. Accordingly, appropriate option (Yes/No) shall be selected.
Customer Approval: This field is mandatory, if option “Yes” selected in the field “Customer Approval Required”. Head/Designee-Quality
Assurance shall select the default work item from the pop-up.
Customer Notification Required: This field shall be applicable when ‘Decision on Change Control’ is selected as ‘Approved’ and Customer
Approval is selected as ‘No’. Head/Designee-Quality Assurance shall take decision and evaluate the requirement of customer notification.
Accordingly, appropriate option (Yes/No) shall be selected.
Proposed Action Plan(s): This field is mandatory, if option “Yes” selected in the field “Customer Notification Required”. Head/Designee Quality Assurance shall select the ‘Notification Action’ and assign to applicable lncharge.
Remark(s)/Reason(s): Head/Designee-Quality Assurance shall specify the reason for selection of option “Not-Approved”.
Customer Approval (Wherever Applicable):
Customer approval work item shall be generated whenever selected at ‘QA Decision’ and available with Head/Designee-Quality Assurance at
‘QA Decision’ block.
Head/Designee-Quality Assurance shall login QAMS.
Comments: Head/Designee-Quality Assurance shall enter the review and comment received on the proposed change from customer.
Customer Details: Head/Designee-Quality Assurance shall specify the customer details e.g. Name of Customer, Person contacted etc.
Customer Decision: Head/Designee-Quality Assurance shall select the appropriate option from “Accepted / Not Accepted” as received from respective customer on proposed change.
Upon selection of “Accepted” option, action plan shall be released for acceptance by in-charge group (concerned department head responsible for that activity).
In case, QRA action plan is accepted and under execution then selection of “Not Accepted” option shall be restricted till QRA action plan not closed/force closed.
Upon selection of “Not Accepted” option, change control shall be available at “Closure Initiation”. Initiator/HOD/In-charge action plan shall receive system generated alert on mail.
Action Plan Proposal (Acceptance/Authorization):
After approval of change control action plan shall be available for further action by in-charge group (concerned department head responsible for that activity). Respective person shall login to QAMS.
In-charge group shall review and take decision on acceptance of action plan and select appropriate option (Yes/No).
If In-charge group selects “Yes” then action plan shall be available for allocation of work.
If In-charge group selects “No” then action plan shall be escalated to Quality Assurance for re-consideration, Quality Assurance shall take appropriate decision from available options i.e. “Yes/No/Return”.
Upon selection of “Yes” option, action plan shall be available for allocation of work for in-charge group. Upon selection of “No” option, action plan shall be terminated. Upon selection of “Return” option, action plan shall be returned to in-charge group for re-consideration.
After acceptance/authorization confirmation, Unique Number (Plan Code) shall be generated by the system automatically.
Action Plan(s) Allocation:
Based on the relevance of work, in-charge group shall allocate action plan to the user/group for execution by selecting “Allocate New Work
Form” through the drop-down menu list.
To assign the work in-charge group shall fill the applicable details in “Work Item Form”.
Work item ID: Unique Number shall be generated by the system automatically.
Work Type: Based on selected action plan, “Work Type” shall be displayed by-default.
Activity Details Form: Action plan in charge shall select the required form based on applicability from the drop-down menu list.
Work Allocation: Action plan in charge shall assign work to “Specific User” or “Specific Group” based on applicability through drop-down menu list.
Work Dependency: Action plan in charge shall identify other work dependency on the work for completion or initiation e.g. second activity cannot be initiated till the completion of first. Action plan in charge shall select the applicable work item from the drop-down menu list. Closed work item shall not be available for dependency.
Start Date: It shall be displayed by-default based on the allocation of work.
Target Date: It shall be displayed by-default based on action plan target date.
Work Description: Action plan in charge shall mention the details of work to be executed.
In-case, additional work is required for action plan, in-charge action shall allocate new, work against the same action plan.
Action Plan(s) Execution:
Initiation: After completion of allocated work the user shall update the status of the executed work and shall attach file (if any).
Allocated work shall follow the pre-defined approval workflow (if applicable), based on the type of work selected.
Approval: If approval is applicable (by-default), then select the relevant hyperlink under the column “Work Item ID”. The approver shall review the action plan and comment on the basis of review. Approver shall take the decision to Approve/Return the action plan work item. If returned, work item shall go back to initiator for re-consideration. If approved from all levels of approvers (based on action plan type), action plan shall be closed. System shall generate the alert e-mail automatically to the concerned group.
Action Plan(s) Closure:
In-charge action plan (concerned department head responsible for that activity) shall review & verify the completion of allotted action plan related work items and comment.
In-charge action plan shall evaluate the need for post implementation review i.e. Effectiveness/ Monitoring (E/M) of the changes.
In-case allocated work items are closed and no additional work item required within the action plan then in charge-action plan shall close the action plan.
In-case any proposed action plan is not required to be executed, then in-charge of action/ plan shall close the action plan forcefully with justification.
Action plans shall be mandatory to close before closure initiation.
Closure Initiation:
Initiator:
Initiator shall verify & ensure the completion all the allocated task and initiate the closure of change control. Initiator shall mention the implementation status/references in field “Implementation Details”.
Based on implementation status, initiator shall specify the status of temporary change and select the appropriate option “Regularized / Partially Regularized / Not-Regularized” in field “Change Control Regularization”.
Upon selection of option “Regularized” or “Partially regularized”, field “Reference CAPA / Change Control No. (if any):” shall be mandatory and initiator shall select reference CAPA / Change Control in this field.
Initiator shall attach file attachment (if required) in field “Initiator-File Attachments (if any)” and shall submit the change control closure to HOD for further review. System shall generate alert mail communication to HOD.
Final Closure:
HOD:
HOD shall review the closure details. Based on the review, HOD shall mention comments in field “HOD Comments” and attach the file (if required) in field “File Attachments (if any) (HOD)”.
HOD shall ensure the completion of all change related activities upon review, HOD shall take decision to “Approve/Return” the change control closure.
If returned Change control closure shall go back to closure initiator for re-consideration and system shall generate alert mail communication to change control initiator.
If approved, change control closure shall be forwarded to Head RA/Designee for further review and system shall generate alert mail communication to Head RA/designee.
Regulatory Affairs:
Head RA/designee shall review the closure details. Based on the review, Head RA/designee shall mention comments in field “RA
Comments”.
Head RA/designee shall take the decision on Change Control Temporary regularization as “Accepted/Not-Accepted” based on review and select the appropriate option in field “Decision on Change Control Regularization”
Head RA/designee shall attach the file (if required) in field “File Attachments (if any) (RA)” and take decision to “Approve/Return” the change control closure.
If returned, change control closure shall go back to closure initiator for re-consideration and system shall generate alert mail communication to change control initiator.
If approved, change control closure shall be forwarded to Quality Assurance for further review and system shall generate alert mail communication to Quality Assurance group.
Quality Assurance:
Quality Assurance shall review the closure details. Based on the review, Quality Assurance shall mention comments in field “QA Comments” final decision on Change Control Temporary regularization as “Accepted/Not-Accepted” from drop down menu list at “Decision” field.
Quality Assurance shall also evaluate the need for E/M plan i.e. Effectiveness/ Monitoring (E/M) of the changes.
Quality Assurance shall take decision to “Approve/Return” the change control closure based on review and attach the file (if required) in field
“File Attachments (if any) (QA)”.
If returned, change control closure shall go back to closure initiator for re-consideration and system shall generate alert mail communication to change control initiator.
If approved, change control shall be closed and system shall generate alert mail communication to change control initiator, HOD and QA.
Quality Risk Assessment (QRA):
QRA shall be concluded first as a mandatory action prior to execution of other proposed actions. QRA Action plan in charge shall allocate work items.
QRA Initiation: Authorized person of concerned department shall carryout QRM as per format (Soft Copy) defined in SOP.
Initiator shall login to QAMS and shall enter the relevant details, QRM (Soft Copy) attachment (It shall be editable attachment) in “Initial Risk
Assessment” field. After completion of applicable entries QRA work shall be submitted to HOD.
HOD Review: HOD / Designee shall login to QAMS and review the attached QRM & relevant details.
HOD / Designee shall propose the action plan (Mitigation Plan) and attach additional files (if required).
‘Quality Risk Review’ action shall be mandatory to propose, in case Mitigation plan proposed.
HOD / Designee shall select other departments for QRM review in field “Department Required to Provide Impact Assessment /Evaluation”.
Based on the review, 1-HOD/designee shall take the decision to ‘Approve/Return’ the QRA and submit. Remarks shall be mentioned incase of selecting “Return” option.
In-case of “Return”, QRA work shall be available with the initiator for necessary action. In case of “Approve”, QRA shall be forwarded to other selected department (If selected). In case no other department selected then QRA work shall be available with Head/Designee-Quality Assurance in QAMS for further action.
Mitigation Plan & Quality Risk Review Plan (if proposed) shall be available for acceptance.
Other Department (s) Comments: Other departments Head/Designee shall login to QAMS.
Head/Designee-Other departments shall review the QRM and shall provide the comment: Head/Designee-Other departments shall attach appropriate documents, wherever required.
Head/Designee-Other departments shall submit the QRA work.
Quality Assurance Review: Head/0esignee-Quality Assurance shall login to QAMS and review the attached QRM. Head/Designee-Quality Assurance shall attach additional files (if required).
Based on the review, Head/0esignee-Quality Assurance shall provide comments and shall attach appropriate documents, wherever required.
Head/Designee-Quality Assurance shall submit QRA work.
Quality Risk Review (QRR):
QRR shall be concluded first as a mandatory action prior to execution of other proposed actions. QRR Action plan in charge shall allocate work items.
QRR Initiation: Authorized person of concerned department shall carryout QRM as per format (Soft Copy) defined in SOP after implementation of mitigation plans.
Initiator shall login to QAMS and shall enter the relevant details, QRM (Soft Copy) attachment (It shall be editable attachment) in “Revised Risk Assessment” field. After completion of applicable entries QRR work shall be submitted to HOD.
HOD Review: HOD / Designee shall login to QAMS and review the attached QRM & relevant details.
HOD / Designee shall provide comments and attach additional files (if required).
Based on the review, HOD/designee shall take the decision to ‘Approve/Return’ the QRR and submit. Remarks shall be mentioned in case of selecting “Return” option.
In-case of “Return”, QRR work shall be available with the initiator for necessary action. In case of “Approve”, QRR shall be forwarded to other selected department (If selected). In case no other department selected then QRR work shall be available with Head/Designee-Quality Assurance in QAMS for further action.
Other Department (s) Comments: Other departments
Head/Designee shall login to QAMS.
Head/Designee-Other departments shall review the QRM and shall provide the comment. Head/Designee-Other departments shall attach appropriate documents, wherever required.
Head/Designee-Other departments shall submit the QRR work.
Quality Assurance Review: Head/Designee-Quality Assurance shall login to QAMS and review the attached QRM. Head/Designee-Quality
Assurance shall attach additional files (if required).
Based on the review, Head/Designee-Quality Assurance shall provide comments. And shall attach appropriate documents, wherever required.
Head/Designee-Quality Assurance shall propose Additional Action Plan Proposal(s) (if any).
Head/Designee-Quality Assurance shall submit QRR work.
Additional Action Plan shall be available for acceptance, if proposed.
Extension Of Target Date (ETD):
Extension of target date shall be applicable for complete cycle and the proposed action plans. Auto generated target date shall appear in the system by calculating 90 working days from the date of initiation for complete change control and 70 working days from the date of initiation for all proposed action plans (In line with system defined holiday calendar).
For extension of target date, ETD for change control shall be initiated by initiator of respective department and ETD for assigned action plans shall be initiated by In charge of respective action plan to whom action plan allotted. Further same shall be reviewed by HOD i.e. change control initiating department head and approved by QA. Target date of action plans may be extended up to issue target date by providing justification/reasons.
System shall restrict the user for executing any work within the issue, if less than 4 working days are available from the target date of issue closure except final QA closure. System shall allow final QA closure till target date of closure.
Target date for Issue login, Issue Closure, Issue Work Items and Action Plan Work Items shall be for intimation purpose.
Effectiveness/ Monitoring (E/M):
“Effectiveness/Monitoring” shall be required for each action plan. If “Effectiveness/Monitoring” not required for an action plan, In-charge of action plan shall select option as “No” and justification for the same shall be mentioned.
“Effectiveness/Monitoring” shall be scheduled for action plans in which “Effectiveness/Monitoring” marked as “Yes”. Effectiveness/Monitoring plan description shall be filled in “Plan Description”. Scheduled frequency for monitoring shall be of 90 days (system default) up to 2 years (system default) and execution duration for each monitoring plan shall be of 10 days (system default). Delay in timeline shall be justified.
If Effectiveness/Monitoring plan(s) selected as “NO”, it shall be justified.
If applicability of Effectiveness/Monitoring plan(s) is not related to No. of batch (es) or no batch manufactured after action implementation, enter ‘O’ in field “No. of Batches Executed after Implementation”.
System shall generate alert mail communication to the authorized user group for effectiveness/monitoring plan(s) as per schedule.
Based on the requirement & justification, Effectiveness/Monitoring plan can be extended beyond 2 years or can be deactivated/Targeted prior to 2 years.
During closure of current “Effectiveness/Monitoring” plan, concern plan in-charge shall review previous “Effectiveness/Monitoring” plan(s).
After the implementation of change, E/M evaluation shall be carried out to determine the introduction of change is successful, effective and no any impact/ risk introduced on the existing system.
System shall generate alert e-mail communication to the HOD of change control for closure initiation after the closure of all action plans excluding the execution/closure of monitoring plans. Incase monitoring plans generated before the closure initiation same need to be closed before the initiation of closure.
Issue Modification Request:
Issue modification request shall be initiated by HOD/designee/Authorized User in QAMS against the document to be corrected/updated, whenever applicable.
In the Modification Request additional approval shall be kept as 1 and additional group (QA Approval) shall be selected from the dropdown menu as per applicability (As per the system default settings).
Initiated request shall be approved by Head/Designee-Quality Assurance.
Correction / updating shall be carried out by the in-charge of group as authorized.
In-case of issue login / Work items/ Closure, correction / update cycle shall be initiated by initiator and then concern cycle related approvers.
Final approval & closure shall be executed by Head-QA/designee.
Additional Departments(s) Selection / Additional Action Plan (s) Proposal:
Head-QA/designee shall evaluate the requirement of additional department(s) and additional action plan(s) prior to issue closure initiation, if required.
Based on the requirement/evaluation, Head/Designee Quality Assurance shall select “Additional Department selection / Additional Action Plan selection” through “Issue Manager – Initiate -Issue Work(s) Allotment” menu.
Head/Designee Quality Assurance shall allocate the Additional department(s) / Additional action plan(s) as applicable through “Issue Manager – QM Activities -All issue Work item(s)” menu.
Work Transfer:
In case of user specific work, if .user not available to whom work is allocated or for re-initiation of work which is returned, work/task shall be transferred to other available user as per job responsibility.
In charge group HOD or QA shall initiate work transfer request and shall define the validity of work transfer, wherever applicable.
Head QA/Designee shall approve/reject/drop the work transfer request as per applicability.
Assigned user shall initiate the work from transferred work list in ‘Issue Manager’ within the validity period.
Assigned user shall initiate the task from ‘Re-initiate’ as applicable.
Printing/pdf Creation:
Authorized user shall prepare pdf of required change control as and when required. The report shall be converted into pdf format or else shall be printed.
Holiday Calendar:
Holiday calendar shall updated well in advance in QAMS for upcoming years by IT at respective site. Upon declaration of new holidays, holiday calendar shall be modified accordingly by IT.
Work item(s) Troubleshoot:
In case, issue work item’s i.e. other department comments, RA Review and QA decision work items not generated (All or partial) after QA review then authorized QA personnel shall release the work items through “Issue Manager – Initiate – Work item(s) Troubleshoot” menu.
5.15.2 Audit log of this work items troubleshoot shall be displayed through
“Issue Manager – Initiate – Work item(s) Troubleshoot Log” menu.
Procedure for Change Control In-Case of QAMS Non-Availability:
In case of QAMS downtime or QAMS system is not implemented, change control shall be initiated and handled through manual system, irrespective of the stage of change control in QAMS.
Upon resume of QAMS services, manual process of change control shall be stopped irrespective of the stage and shall proceed in QAMS by attaching manual change control documents.
After closure of change control in QAMS, printout of same shall be enclosed with manual change control documents and shall be submitted to QA as per relevant procedure.
QAMS change control number i.e. issue code and reason for QAMS failure shall be mentioned in remarks column of manual change control logbook.
The person initiating the change shall outline the information(s) in the change control form as required.
Initiator shall describe the current practice, details of the proposed changes in the sequential manner in line with current practice.
Initiator shall provide justifications in the sequential manner in line with proposed changes and mention the details of supporting data, reference, and list of attachment and attach the same along with change control form wherever required.
After signing, the initiator shall forward change control form to HOD for review.
Initiating department head/ designee shall review the proposed change and comment. HOD shall propose the action plan based on impact assessment.
HOD shall sign the change control form and shall forward the same to QA Department for review and login.
After receipt of change control form, Quality Assurance shall review and comment.
Quality Assurance shall log the proposed change in respective Change Control logbook specified for each facility/ department.
Quality Assurance shall assign identification number for Permanent Change Control.
QA shall handover the form to the initiator for getting review comments of other concerned and/ or relevant departments.
Other departments Head/ designee shall review the proposed change and shall provide the comment based on the impact of the change.
Other departments Head/ designee shall define actions required to be taken for evaluation or for implementation.
After review of all concerned department, initiator shall forward the change control form to Regulatory Affairs department for review.
Regulatory affairs Head/ Designee shall review proposed change and take decision as “Approved/ Not Approved”. If approved, Regulatory affairs Head/ Designee shall mention the regulatory requirement and forward it to Head/ Designee-Quality Assurance.
In-case of Not-Approved, Quality Assurance decision shall be not required on change control form. RA shall handover the form to the initiator for closure.
Based on the review of proposed change along with comments of other departments, Head/ Designee-Quality Assurance shall take the decision “Approved / Not Approved” on change control.
Head/ Designee-Quality Assurance shall have the authorization to revisit/ negate the comments of other departments. Depending upon the impact of change, Head/ Designee-Quality Assurance shall categorize the change control as “Major/ Minor”.
Head/ Designee-Quality Assurance shall inform to initiator for necessary action as required.
ORM shall be mandatory, if change control is categorized as “Major”, else QRM shall be optional for execution.
In case of Major change control, proposed change(s) shall be executed only after closure of ORM.
On approval, proposed changes shall be implemented within 90 working days from the date of initiation.
Target date shall be extended and justification shall be provided in case of delay in closure by more than 90 working days from the date of initiation.
Upon implementation of proposed change, concerned person from initiating department shall verify & ensure the completion of all the required activities.
Closure initiator shall fill the required details in ‘Change Control Closure’ form.
Closure Initiator shall mention relevant document number with effective date wherever applicable in change control closure form.
Initiator shall forward to head of initiating department/ designee after signing change control closure form.
Head of initiating department/ designee shall review & comment on the closure activity and forward the same to Regulatory affairs.
Regulatory affairs Head/ Designee shall review & comment on the closure and forward the same to Quality Assurance.
In case of Temporary change control, Regulatory affairs Head/ Designee shall take decision on temporary change control regularization as “Accepted/ Not-Accepted”.
Head/ Designee-Quality Assurance shall review & comment on the closure.
Head/ Designee-Quality Assurance shall update the status of change along with implementation details of proposed change (i.e. Implemented/ Partially Implemented/ Not Implemented) for Permanent Change Control.
Head/ Designee-Quality Assurance update the status of change along with final regularization status of proposed change as “Accepted / Not Accepted” for Temporary Change Control.
Head/ Designee-Quality Assurance shall also evaluate the need for monitoring/ post implementation review of the change control based on nature of change impact on quality of product and finally close the change control.
Risk Assessment shall be performed for the changes classified as major, by initiating department as per SOP “Quality Risk Management” or applicable site SOP.
Initiator shall verify the editable documents before signing off the SOP/Specification to ensure incorporation of all recommended and justified changes.
Change controls initiated before implementation of QAMS shall be closed by using Annexure 8 or respective change control form as applicable.
The details of product-related change controls are reported in the relevant drug product API Annual Product Quality Review (APQR) reports.
In case of changes requiring prior approval from respective regulatory agencies / customer, the change shall be implemented only after obtaining written communication / approval from the concerned authority/ customer.
Regulatory Affairs Head / Designee shall acknowledge the implementation of change to the concerned regulatory agencies as applicable and also to inform customers (wherever applicable) for changes agreed in technical/supply agreement.
Head Quality Assurance / Designee shall inform customers for changes agreed in technical/supply agreement, wherever applicable.
In case, any amendment is required to the initial change control request which has been approved earlier and not yet implemented (e.g. some more changes proposed to SOP), the initiator shall fill another change control and follow the change control procedure. Initial change control shall be selected as reference in new change control and new change control shall be selected as reference in closure of parent change control.
ABBREVIATIONS:
ANDA: Abbreviated New Drug Application
CCP: Change Control Permanent
CCT: Change Control Temporary
QAMS: Quality Assurance Management System
ORM: Quality Risk Management
QRA: Quality Risk Assessment
QRR: Quality Risk Review
