Procedure for QA Review of Raw Materials
| Department | Quality Assurance (QA)/Quality Control (QC)/Production |
|---|---|
| SOP No. | SOP/Ointment/081 |
| Supersedes | V 1.0 |
| Page No. | Page X of Y |
| Issue Date | [Insert Issue Date] |
| Effective Date | [Insert Effective Date] |
| Review Date | [Insert Review Date] |
1. Purpose
The purpose of this Standard Operating Procedure (SOP) is to establish a standardized method for the Quality Assurance (QA) review of raw materials used in ointment manufacturing. This ensures compliance with specifications, regulatory requirements, and Good Manufacturing Practices (GMP).
2. Scope
This SOP applies to all personnel in the QA, Quality Control (QC), and Production departments involved in the review, approval, and release of raw materials before use in manufacturing.
3. Responsibilities
- Quality Assurance (QA) Officer: Conducts the review of raw materials and associated documentation.
- Quality Control (QC) Analyst: Performs analytical and microbiological testing of raw materials.
- Warehouse Supervisor: Ensures proper storage and handling of raw materials.
- Production Manager: Ensures only QA-approved raw materials are used in production.
4. Accountability
The QA and QC Managers are accountable for ensuring that raw material review is conducted as per regulatory requirements and that only compliant materials are approved for use.
5. Procedure
5.1 Raw Material Documentation Review
- Check the Certificate of Analysis (CoA) from the supplier.
- Verify batch number, manufacturing date, and expiry date.
- Ensure compliance with predefined specifications.
- Review Material Safety
Data Sheet (MSDS) for handling precautions.
5.2 Physical and Chemical Examination
- Inspect packaging integrity and labeling details.
- Verify the appearance, color, odor, and texture of raw materials.
- Ensure that no contamination, leakage, or tampering is observed.
5.3 Quality Control Testing
- Perform identification tests using analytical methods (e.g., HPLC, FTIR).
- Check pH, moisture content, and purity levels.
- Conduct microbiological testing to detect potential contamination.
5.4 Storage and Handling Review
- Confirm that raw materials are stored as per defined environmental conditions.
- Ensure segregation of approved, rejected, and quarantined materials.
- Monitor storage conditions (e.g., temperature, humidity).
5.5 Approval or Rejection
- If raw materials meet specifications, approve them for use.
- If materials fail to meet specifications, quarantine them and initiate corrective actions.
- Document approval or rejection status in the Raw Material Review Log.
5.6 Documentation
- Record all raw material review data in the QA Review Log.
- Attach relevant documents, including CoA, MSDS, and test results.
- QA must sign off on the final approval before raw material release.
6. Abbreviations
- GMP – Good Manufacturing Practices
- QA – Quality Assurance
- QC – Quality Control
- CoA – Certificate of Analysis
- MSDS – Material Safety Data Sheet
7. Documents
- Raw Material Review Log (Annexure-1)
- Raw Material Approval Report (Annexure-2)
8. References
- WHO GMP Guidelines for Pharmaceutical Manufacturing
- ICH Q7 – Good Manufacturing Practice for Active Pharmaceutical Ingredients
- USP <1116> – Microbiological Control and Monitoring
9. SOP Version
Version 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Raw Material Review Log
| Date | Material Name | Batch Number | CoA Verified | Physical Inspection | QC Test Result | Final Status | Verified By |
|---|---|---|---|---|---|---|---|
| 01/02/2025 | White Petrolatum | WP-101 | Yes | Pass | Pass | Approved | QA Officer |
| 02/02/2025 | Mineral Oil | MO-102 | Yes | Pass | Fail | Rejected | QA Officer |
Annexure-2: Raw Material Approval Report
| Date | Material Name | Batch Number | Specification Compliance | Result | Final Status | Approved By |
|---|---|---|---|---|---|---|
| 01/02/2025 | White Petrolatum | WP-101 | Meets Spec | Pass | Approved | QA Head |
| 02/02/2025 | Mineral Oil | MO-102 | Does Not Meet Spec | Fail | Rejected | QA Head |
12. Revision History:
| Revision Date | Revision No. | Details of Revision | Reason for Revision | Approved By |
|---|---|---|---|---|
| 01/01/2024 | 1.0 | Initial Version | New SOP | QA Head |
| 01/02/2025 | 2.0 | Updated SOP Format | Standardization of Document | QA Head |