Change Control Review SOP
Change Control Review is the procedure for review and change control of formats originated through Standard Operating Procedures (SOPs), This procedure is applicable for review and changes control of formats in the instances, where only the respective format(s) required to be reviewed, with out revising the SOP for better documentation practices.
PROCEDURE
When ever a change becomes necessary or desirable to the formats of any SOPs of the user department, the concerned personnel of the department, shall raise a CRF outlining , the proposed change(s) and the reasons for change(s), attach supporting documents, if any and forward to the Head of the department.
Head of the department shall review and approve the change, if acceptable and forward to Head – QA with his comments.
Head – QA shall review the change(s) and approve the change(s), if acceptable and forward to Officer – Documentation, for implementation.
Officer – Documentation shall take the final print of the format and allot the revised format number for the new format.
Officer – Documentation shall assign effective date for the revised format, mention effective date on the specimen of the revised format as well as CRF and file the original CRF in ‘File for CRFs’.
Officer – Documentation shall take number of copies of the new format as required from the SOP issue register and he shall replace the old formats with new formats in the respective SOPs.
Officer – Documentation shall reconcile the superseded formats and destroy.
The superseded format of the Master copy shall be stamped as ‘OBSOLETE FOR REFERENCE ONLY’ and retain in the same SOP.
PROCEDURE
Procedure for change initiation
Upon identification for need of change, concern person shall collect “Change Control Form” from QA.
QA person shall make following entries in “Change Control Register” while issuance of the CC form.
Change control number
Assign the change control number as per CC numbering procedure.
Assigned by
The QA person who is issuing the change control shall put his/her initial.
Date of issuance
The QA person who issued the CC form mention date on which the change control is issued.
Department
The QA person mention the name of the department to which the change control is issued.
Initiated by
The QA person take signature of the person or mention name of the person to whom the change control is issued.
Product (For temporary change)
The QA person mention the name of product for which the change is initiated.
Batch no. (For temporary change)
The QA person mention batch number of the product for which the change is initiated.
Target Completion Date (TCD):
target completion date is the date by which any change control should be closed. It shall be assigned by the concern dept. head. The maximum period target completion date up to 90 days can be allotted.
Revised TCD:
Revised completion date shall be assigned in case change not completed within given time from the concern dept. head shall discuss with QA to increase revise the target completion date with reason format completion with given time frame.
Document (For permanent change)
The QA person mention the name of document like Batch Manufacturing Record, Standard Operating Procedure, Analytical test procedure, Specification etc.
Document no. (For permanent change)
The QA person mention document number (Master BMR No., SOP No., Specification No. etc. with version number) for which change is being initiated.
After making entries into CC register, QA shall make the same entries in change control form.
Identifying type of change:
Concerned person (initiator) shall, mention/select type of change based on need for change i.e. Temporary change or Permanent change.
Temporary change
A change (departure from any established procedure/system/process) initiated for user trial/history for the evaluation of proposed procedure/system/process, which has been taken with prior approval to achieve the desired output.
Temporary change is one time change and limited to a particular batch or campaign of batch activities. For example change in batch size, manufacturing equipment, etc.
Permanent change:
A change initiated based upon scientific rationale or historical data. OR A change initiated with a back up of minimum three batches successful / satisfactory temporary changes data.
Procedure for temporary change:
Follow the procedure explained under procedure for change initiation.
Concerned person (initiator) shall further fill the change control form as explained under below. (Note: In case space provided in CC form is not sufficient, below details may be given on a separate sheet as an attachment to the CC form.)
Existing system
Initiator shall mention details of existing process/ formula/ procedure / specification that is being followed.
Proposed change
Initiator mention details of proposed process/ formula/ procedure / specification to be followed.
Rationale/Justification
Initiator mention justification based on scientific rationale & /or supporting data like history, trend, stability data and experience or any other to ensure no adverse impact on product quality.
Evaluation for requirement of change: If not justifiable
If the requirement for change is not justifiable or not agreed, department head shall include justification to close the change control, approval for the same shall be taken from QA head and it shall be sent to QA for closing.
Evaluation for requirement of change: If justifiable.
If the requirement for change is justifiable or agreed, department head shall evaluate the requirement for change and shall approve the same if found satisfactory.
Recommendations for impact analysis:
Department head shall give recommendations for impact analysis.
Adequacy of impact analysis shall be concurred by QA head & Plant head. [A detailed guideline is given in for type of change v/s Possible impact for more clarification].
The impacted department head shall be informed for the recommendations given under each impact and signature for the same shall be taken from the impacted department head.
Approval for execution
After ensuring recommendations under impact analysis and signature of impacted department head, the concern department head shall give approval for the execution and shall arrange to get the approval from QA and Plant head.
CAPA (Corrective and preventive action) issuance and monitoring
QA shall issue CAPA to the impacted department head to monitor the each recommendation.QA shall enter the CAPA number in the relevant column, where CAPA is issued.(Normally CAPA shall be issued for long term action, however it may be used at the plant QA head decision for other impact.
Execution
The concern person shall execute the change in coordination with QA and impacted department & shall prepare assessment report/data.
Review impact evaluation /Recommendations (Review of recommendations).
After execution of the change the concern department head and the impacted department head shall submit the change control along with CAPA and supporting data/ assessment report to QA for the review of impact evaluation / recommendations.
Change control implementation status (Evaluation and conclusion)
Based on review of above data/ assessment report / outcome / results (satisfactory/not satisfactory) QA shall make final conclusion, whether the change was executed successfully or not and shall close the same.
7.3 Procedure for permanent change:
7.3.1 Follow the procedure explained for change initiation (refer point 7.1).
7.3.2 Concerned person shall further fill the change control form as explained under below.
Note : In case space provided in CC form is not sufficient, below details shall be given
on separate sheet as an attachment to the CC form.
Existing system
Initiator mention details of existing process/ formula/ procedure / specification that is followed.
Proposed change
Initiator mention details of proposed process/ formula/ procedure specification to be followed.
Rationale/Justification
Initiator mention justification based on scientific rationale & / or supporting data like history, trend, stability data and experience or any other to ensure no adverse impact on product quality.
Evaluation for requirement of change: If not justifiable
If the requirement for change is not justifiable or not agreed, department head shall include justification to close the change control, approval for the same shall be taken from QA head and it shall be sent QA to close.
Evaluation for requirement of change: If justifiable.:
If the requirement for change is justifiable or agreed, department head shall evaluate the requirement for change and shall approve the same if found satisfactory.
Recommendations for impact analysis
Department head shall give recommendations for impact analysis.
Based on recommendations, either direct change shall be taken or change shall be planned based on three batches temporary change data as explained of the flow chart.
Adequacy of impact analysis shall be concurred by QA head & Plant head.
The impacted department head shall be informed for the recommendations given under each impact and signature for the same shall be taken from the impacted department head.
If there is impact on regulatory aspect, the change control shall be forwarded to regulatory head(Mankind group) for approval along with data or proposal given in accordance with guideline on post approval changes criteria for respective national regulatory bodies.
Regulatory approval: If No
If the change is not acceptable or justifiable to regulatory, QA head shall include proper justification in the change control and shall forward it to QA. QA shall take approval from location head and shall close it.
Regulatory approval : If Yes
If the change is acceptable or justifiable to regulatory, QA head shall approve the change control and send it to department head.
Department head shall take approval for the same from location head and shall inform to concern person to execute the change.
After getting the approval from the regulatory and based on recommendations i.e. either direct change shall be taken or change shall be planned based on three batches temporary change data.
Direct change
Direct change shall be taken based on scientific rationale or historical data or R & D data. As mentioned under justification section of the change control.
Approval for execution
After ensuring recommendations under impact analysis and signature of impacted department head, the concern department head shall give approval for the execution and shall arrange to get the approval from QA and Plant head.
CAPA issuance and monitoring
QA shall issue CAPA to the impacted department head to monitor the each recommendation, as applicable.
Execution
The concern person shall execute the change in coordination with QA & impacted department and prepare report/data.
For the execution of this change, three batches temporary change shall be executed evaluated and concluded one by one. Refer temporary change control procedure.
If the first temporary change found successful, conclusion shall be made and second temporary change shall be planned.
If the first temporary change found not successful, conclusion shall be made and the change control shall be closed.
Review impact evaluation /Recommendations (Review of recommendations)
After execution of the three batches temporary changes, the concern department head and the impacted department head shall submit the change control along with CAPA and supporting data/assessment report to QA for the review of impact evaluation /recommendations.
Change control implementation status (Evaluation and conclusion)
Based on review of above data/ assessment report / outcome / results (satisfactory/not satisfactory) QA shall make final conclusion, whether the change was executed successfully or not and shall close the same after ensuring implementation details i.e. effective batch/document number and date.
Updating of change control register
After closing the change control QA shall update the change control register.
Change based on three temporary changes data
If it is recommended to take temporary changes for data generation to support permanent change, three temporary changes shall be planned.
Approval for execution
After ensuring recommendations under impact analysis and signature of impacted department head, the concern department head shall give approval for the execution and shall arrange to get the approval from quality and Plant head.
CAPA issuance and monitoring
QA shall issue CAPA to the impacted department head to monitor the each recommendation.
Execution
The concern person shall execute the change in coordination with QA & impacted department and prepare report/data.
For the execution of this change, three batches temporary change shall be executed evaluated and concluded one by one. Refer temporary change control procedure.
If the first temporary change found successful, conclusion shall be made and second temporary change shall be planned.
If the first temporary change not found successful, conclusion shall be made and the change control shall be closed.
Review of impact evaluation /Recommendation (Review of recommendations)
After execution of the three batches temporary changes, the concern department head and the impacted department head shall submit the change control along with CAPA and supporting data/assessment report to QA for the review of impact evaluation /recommendations.
Change control implementation status (Evaluation and conclusion)
Based on review of above data/assessment report/out come/results (satisfactory/not satisfactory) quality assurance shall make final conclusion, whether the change was executed successfully or not and shall close the same after ensuring implementation details i.e. effective batch/document number and date.
Updating of change control register
After closing the change control QA shall update the change control register.
Forms and Records (Annexures)
Specimen format of “Change Request Form” – Annexure 1.
Distribution
Master copy – Quality Assurance
Controlled copies- Quality Assurance, Production, Quality Control,engineering
History
| Date | Revision Number | Reason for Revision |
| – | 00 | New SOP |
Annexure 1
Specimen format of “Change Request Form”
HANGE REQUEST FORM
Initiated by:___________
Date:__________
Department:____________________
- Format No. :
- Format Title :
- Proposed change :
- Reasons for change :
- Comments of Department Head :
- Change(s) acceptable:
- (Put Ö mark in the appropriate box)
- Comments of Head – QA :
- Change(s) Approved:
- Other connected SOPs (Nos.) :
- Superseded format(s) was replaced with the new format and superseded format(s) were destroyed.
- The stamped master copy of the superseded format with ‘OBSOLETE FOR REFERENCE ONLY’ in the respective master copy of the SOP.
