- 1. What is Change Control:
Any planned permanent or temporary departure or modification or addition or deletion from an approved/qualified process/policy/document/system/material/method/equipment etc. is called as change and the document which is required to capture all the activities is called change control.
Change control can be permanent or Temporary.
- 2. When to take Change Control:
Change control has to taken for the following criteria mentioned below (But not limited to)
Change in Manufacturing process
Change in Product formulation
Change in HVAC systems / Air handling systems / air filtration systems;
Change in Batch / lot size
Change in Manufacturing, packaging and analytical equipment;
Change in Facilities & Utilities & Water systems
Change in Raw Materials, Intermediates, Packaging materials
Change in Analytical testing methods & specification,
Change in Manufacturing Site
Change in Stability (shelf life, retest period, storage and transport conditions)
Change in Pharmacopoeia or existing monograph
Artwork related changes
Addition, deletion of new equipment or new product.
Changes in Batch documents (Batch Manufacturing Record and Batch Packing Record)
Changes in Standard Operating Procedure (SOP)
Changes in Calibration schedule and Preventive Maintenance for all instruments
- 3. Who shall fill the change control form & who will review the same
The initiator shall fill the required details in change control form with Current status, proposed change, appropriate reason or justification for change, Assessment of the change and the risk analysis and department Head of initiator department shall review the change control form along with all supportive data and supportive information.
- 4. What is the responsibility of change control coordinator
The change control coordinator shall review the change control form filled by the initiator & enclosed documents for correctness & completeness.
The change control coordinator shall also review the risk assessment provided for the change, if acceptable shall proceed for next stage.
The change control coordinator shall select the reviewer departments for impact assessment and comments and based on the details provided, change control coordinator shall categorize the change control as major and minor.
- 5. For which type of Change Control Risk Assessment Report is required
Quality risk assessment report shall be prepared during change evaluation. E.g. New product introduction at site, Addition of alternate source of API, Addition of alternate source of Empty Hard gelatin capsule, change in Batch size, (i.e. addition of higher capacity equipment’s) and introduction of new equipment’s at site etc.
- 6. What is Major Change in Change Control
Any change in the product, production process, quality controls, equipment, facilities, or responsible personnel that have a substantial potential to have an adverse effect on the identity, strength, quality, purity, or potency of the product as they may relate to the safety or effectiveness of the product.
E.g. Addition/ / deletion of New API source or change in existing API source, Introduction of New Product at site and Change in Manufacturing Formula/ Manufacturing Process/ Batch Size, Installation/Modification of Critical Equipment like Fluid Bed Equipment, Rapid Mixer Granulator, Change in packing process and change in specification for Raw and packing materials .
- 7. What is Minor Change in Change Control
Any Changes in the product, production process, quality controls, equipment, facilities, or responsible personnel that have a minimal potential to have an adverse effect on the identity, strength, quality, purity, or potency of the product as they may relate to the safety or effectiveness.
E.g. Change in format or document and change in Standard Operating procedure and editorial changes, Modification/ Elaboration of Standard Operating Procedures, Revision of RM/PM analytical method for Correction of typographical error etc.
- 8. Are all the change control shall be forwarded to Regulatory affairs for comments
No all change Control shall not be forwarded to Regulatory affairs for comments but submission or filling batches related Change controls, validation related change controls etc. shall be forwarded to RA to know the regulatory impacts as per US and Europe variation requirements.
- 9. Which type of change control shall be forwarded to Customer or Qualified person for comments or Approval or notification
All the product related change control (change in batch size, addition of alternate sources of Active pharmaceutical Ingredients or Empty hard gelatin capsule, Change in product shelf life, and change in packing material etc.) Shall be forwarded to the customers or Qualified person for Approval or notification
- 10. What is the timeline for Closing of Change Control
All change control forms shall be closed within 90 days from the final approval or as per target completion dates and two extension ( 90 days for each) can be taken for closing of change control with justification for delay but Change control closing timelines shall not be applicable for change controls raised for the introduction of new product at site.
- 11. What happen if change controls are not closed within timeline
If the change control are not closed within the specified timeline after extension Quality risk assessment report shall be prepared to justify the risk of not implementing the changes
- 12. What is the frequency of review and trending of change control and what will be the contains of change control trend
Change control shall be reviewed on monthly basis to know the status of open change controls and Trending of the Change control shall be done on Quarterly basis.
The review shall comprise minimum of the no. change controls initiated, approved, closed, overdue during the review period. The change control review may be carried out department wise, category wise, type wise and any specific highlights during the review period like repetitive temporary change controls.
The effectiveness of the changes implemented during review period shall be included into the review.
Change controls e.g. equipment related, facility related, system related change controls which are implemented and closed can be considered for the verification/review of the effectiveness of implementation.
- 13. What is the Responsibility of Head QA in Change control
All the change controls shall be approved by Head Quality assurance after compilation of actions required for implementation and shall be responsible for the seeking approval from Marketing authorization holder, Customer, CQA, Qualified person (QP).
Head QA shall review the change control log monthly for status of change controls and completeness and correctness of change control log and take necessary actions for any overdue change controls.
- 14. What is Like to Like Changes in change control
Replacement of a piece of equipment by another one with identical characteristics and function (same material of construction, size, type etc. but not necessarily from the same manufacturer).
These changes might have very minor effect or no effect on critical parameters, critical attributes or equipment’s functionality, however impact of these changes shall be accessed through site procedure for preventive maintenance and breakdown maintenance (e.g. Replacement of minor identical parts during breakdown or preventive maintenance)
- 15. How change control shall be closed
Upon completion of all the activities stated in action plan of change control, initiator shall send the duly filled change control form along with all attachments (i.e. supporting documents) to QA for review and closure.
The change control coordinator shall review the change control form along with all supporting documents for completeness and correctness and ensure that all necessary actions are completed.
Upon satisfactory review of QA, Change control form shall be closed and same shall be updated in change control log.