Change Control is a systematic process used to manage all changes made to a product, process, or system. It's especially important in regulated industries like pharmaceuticals, IT, and manufacturing, where unapproved or undocumented changes can affect quality, safety, or compliance.
🔍 Definition:
Change Control is a formal process to ensure that any proposed change is properly reviewed, approved, implemented, and documented.
🧪 In Pharmaceuticals (as per GMP guidelines):
Change Control ensures that any change to materials, equipment, procedures, environment, or personnel does not adversely affect product quality or compliance.
🔄 Types of Changes:
1. Planned Change – A known and intentional change (e.g., replacing equipment).
2. Unplanned Change – A change done due to emergency or unexpected reasons (e.g., breakdown of HVAC).
3. Temporary Change – A short-term change with a set return-to-normal date.
4. Permanent Change – Long-term or irreversible modification.
✅ Key Steps in Change Control:
1. Initiation – Identify and document the proposed change.
2. Risk Assessment – Evaluate the impact on quality, safety, and compliance.
3. Review and Approval – QA, regulatory, and other departments review the proposal.
4. Implementation – Execute the approved change under controlled conditions.
5. Verification – Confirm the change was correctly implemented.
6. Closure – Document and formally close the change request.
📋 Examples in Pharma:
Changing raw material supplier.
Modifying batch size.
Updating an SOP.
Installing a new water purification system.
🛑 Why is Change Control Important?
Ensures product quality and consistency.
Maintains regulatory compliance (GMP, FDA, WHO, etc.).
Reduces risks of errors, contamination, or product reca
lls.
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