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.

What is Change control Procedure:

A formal system by which qualified persons or Subject matter Expert of different departments review proposed or actual changes that might affect a validated status of facilities, system, equipment, Document or processes.

When Change control has to taken :

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;

Change in Raw Materials, Intermediates, Packaging materials;

Change in Analytical testing methods & specification,

Change in Water systems;

Change in Manufacturing Site;

Change in Stability (shelf life, retest period, storage and transport conditions);

Change in Pharmacopoeia or existing monograph

Artwork related changes

Changes in Computer Systems and Software.

Addition, deletion of new equipment or new product.

Changes in Batch documents (BMR and BPR)

Changes in Standard Operating Procedure (SOP)

Changes in Calibration schedule and Preventive Maintenance for all instruments

Flow Chart of Change Control :

Step wise Procedure of Change Control:

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.

The Justification of change shall be described in sufficient details so that reviewers and approvers clearly understand the rationale and need for the change. If required supporting data to be attached for justification.

In the risk analysis stage wherever applicable Quality risk assessment report shall be prepared during change evaluation. e.g. New product introduction at site and change in alternate source of API etc)

The Department Head of initiator department shall review the change control form along with all supportive data and supportive information.

Upon satisfactory review from Department Head; the change control form shall be submitted to change control coordinator in Quality assurance department of respective site.

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.

What is Major Change: 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.

What is Minor Change: 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 etc.

Change control coordinator shall allocate a unique serial number to the change control form and update the same in change Control log Book as well as in Excel Sheet.

After completion of impact assessment and categorization (like minor & Major), the change control form shall be returned to the initiator and Initiator shall circulate the form to concerned departments for their assessment of the proposed changes.

The change control form shall also be forwarded to the Regulatory affairs department for the impact assessment over the submission/filing as per requirement. (Pl note that all change controls shall not required Regulatory affairs impact assessment)

The change control form shall also be forwarded to the customer or Qualified Person (QP) for Approval and the scan copies or e-mails or other correspondence received from Regulatory and Customer shall be archived with original change control form. (Pl note that all change controls shall not required customer/QP Approval or notification)

Comments from other departments and Marketing Authorization holder/Qualified Person/SME (Subject matter expert) shall be reviewed for its relevance prior to approval of the change control.

Then the change control coordinator shall forward the change control form to Head-QA for final approval and Head-QA/ Authorized designee shall approve the Change control form.

After approval from Head-QA, Head Corporate Quality Assurance (in case of major change controls), the change control form shall be circulated to the concerned person as scan copy.

If any change control form is rejected, then the same shall be informed to the initiator and recorded in Change control log and the change control form shall be retained by QA. The number allotted to change control form shall not be reused for next change control form and next number shall be continued accordingly.

After approval of change control form, initiator shall follow a step wise action plan for implementation of the proposed changes.

Initiator shall ensure the timely completion of all tasks stated in action plan (Section 5) and If the task stated in action plan is not completed within the target completion date, then initiator shall submit the change control extension form

Upon completion of all activities stated in action plan, initiator shall send the duly filled change control form along with all attachments to QA for review and closure and the change control coordinator shall review the change control form along with all attachments 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 as well as in Excel sheet.

The follow-up status of the open changes shall be tracked on the Monthly basis by QA.

All change control forms shall be closed within 90 days from the final approval or as per target completion dates mentioned in section 5 of change control form and shall be retained perpetually in the custody of quality assurance.

Change control management system timelines shall not be applicable for change controls raised for introduction of new product at site.

Change Control Form

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