SOP for In-Process Quality Control.
Standard Operating Procedure (SOP)
1. Purpose:
To define the procedure for monitoring and ensuring product quality during the manufacturing process.
2. Scope:
Applies to all manufacturing batches processed in the facility.
3. Responsibility:
- IPQC Officer: Perform checks and document findings.
- Production Staff: Assist and comply with QC instructions.
- QA Manager: Review and approve IPQC records.
4. Procedure:
4.1 Start-Up Checks
- Verify equipment cleanliness and status before batch start.
- Confirm raw materials and batch numbers.
4.2 In-Process Checks
- Perform checks at predefined critical stages, including:
- Weight variation
- pH or viscosity
- Tablet hardness/thickness (for tablets)
- Mixing/blending uniformity
- Temperature/time parameters
- Visual inspection of product and packaging
4.3 Recording Results
- Record observations and values in IPQC log sheet.
- Report any deviations immediately.
4.4 Handling Deviations
- Isolate affected material.
- Notify QA/Production Supervisor.
- Conduct root cause analysis and corrective action.
4.5 Final Clearance
Ensure all parameters met before allowing the batch to proceed to the next stage or final packaging.
5. References:
- Batch Manufacturing Record (BMR)
- Product Specification Sheet
- GMP Guidelines
6. Attachments:
- IPQC Checklist
- Deviation Report Form
- Calibration Logs (if applicable).
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