SOP On Change Control In a pharmaceutical company
A procedure to ensure that no changes are made in any approved pharmaceutical product, manufacturing process, GMP-related equipment/facility/utility, computer system, Standard Operating Procedures (SOPs), Standard Cleaning Procedures (SCPs), Master Production Records, specifications, standard test procedures, the vendor of raw materials and Primary / Printed packaging materials, packaging and labeling until the requested change is reviewed, approved and deemed effective by Change Control Committee.
The change control committee consists of the Head of the Quality Assurance Department, the respective department head requesting the change, and other Heads of concerned departments which may be affected by the change.
Head of Quality Assurance Department to ensure compliance.
Whenever a change becomes necessary or desirable the concerned Officer prepares a “Change Request ” (CR) (annexure-1) outlining the proposed change and the reason for the change, attaches supporting documents, if any, and forward it to the department head.
Note: Changes covered by a “Change Request” may include, but are not limited to the following:
Changes requesting an additional or alternate source of raw materials.
Changes in manufacturing procedures.
Change in product colour, shape, and size.
Change in packaging and labeling.
Changes to process and/or testing equipment.
Changes to cGMP facility or cGMP facility utilities.
Changes to the computer system used for cGMP purposes.
Changes to Master Production Records
Changes to Specifications.
Changes to Standard test procedures and General test procedures.
Changes to SOPs and SCPs
Changes to Registration dossiers etc.,
The initiator of the Change Request (CR) shall mention the type of change requested, the respective document reference number if the change is proposed in an approved document, and briefly summarize the proposed change and reasons for the change in the respective columns on the CR, and forward to Department Head.
The Department Head shall enter his comments under the column for Department Head and forward the CR to the Head of the Quality Assurance department (change control coordinator) for his comments.
The Change Control Coordinator or his designee shall assign a number to the request and enter that number and a brief description of the proposed change with the date received into the “Change Control Request Log” (annexure-1). The Change Request Number shall consist of nine characters.
The first two characters are department codes indicating the department from which the Change Request Notice originated. The department codes are given in Annexure-2
The third character is the alphabet ‘C’ denoting Change Control.
The next three characters are serial numbers starting from 001 on every new year (from 1st January).
The seventh character is a ‘/’ (slash).
The last two characters are numerical indicating the year.
The first change request notice raised in the year 2023 by the QC department shall be numbered QCC001/23.
The Change Control Coordinator shall forward the Change Request with comments to other Heads of the concerned Departments that may be affected by the change and may call for a Change Control Committee Meeting. The Change Control Committee members shall review the Change Request and decide on accepting or rejecting the request based on the comments received and appropriate regulations, Industry practices, and cGMP compliance.
The members of the Change Control Committee shall evaluate the Change Request with respect to aspects of Validation, Regulatory approval, Stability studies, etc.
The members of the Change Control Committee shall be unanimous in accepting or rejecting a Change Request. In the event of any disagreement, the change control coordinator may call for a change control committee meeting.
The Change Control Committee members shall sign and forward the Change Request to the Change Control Coordinator with their comments.
The Change Control Coordinator shall compile the summary of Change Control Committee comments, and whether the change request is approved or rejected, he shall mention the same in the respective columns on the CR.
The summary compiled on the CR shall be entered in the Change Request Log under the column for “Remarks about proposed change” and whether CR is approved/rejected in the respective column.
The initiating department shall be communicated whether the CR is approved or rejected, by the change control coordinator.
If the change request is accepted by the committee members and Validation/Regulatory submission / Stability testing / Customer notification/Training etc., is required, the Change Control Coordinator shall coordinate with the respective Head of Department to complete the same.
After fulfilling the above requirements, the Change Control Coordinator shall review the completion of the proposed change and assign an effective date for implementation. The same shall be informed to the initiator and other concerned heads of departments.
The effective date assigned on the CR shall be entered on the Change Request Log in the column for ‘Effective date of change’.
Approved and completed change request notices along with other supporting documents shall be filed in the “File for change request notice” kept in QA Office.
Any additional changes proposed which are to be included after a CR is approved shall be written on the annexure for change request notice and sent for approval to the concerned members of the change control committee.
Head Regulatory Affairs or his designee shall inform or keep the customer notified of the relevant changes if required and wherever applicable.
Forms and Records (Annexures)
Specimen format of “Change Request” – Annexure-1.
List of Department Codes – Annexure-2.
Master copy – Quality Assurance
Controlled copies- Quality Assurance, Production, Quality Control, engineering
|Date||Revision Number||Reason for Revision|
CHANGE REQUEST LOG
- Change Request
- Notice Number
- Initiator Dept/Area
- Proposed change
- Remarks about the proposed change
- The effective date of the change
List of Department Codes
Quality Assurance – QA
Quality Control– QC
Research & Development– R&D
Analytical Laboratory Development– ALD
Regulatory Affairs– RA
Pilot Production– PP
Production Planning– PL
Administration – AM
Information Technology – IT
Novel Drug Delivery Research -NR
Bio Analytical -BA