Procedure for Conducting QA Audits in Ointment Manufacturing
| Department | Quality Assurance (QA)/Compliance |
|---|---|
| SOP No. | SOP/Ointment/087 |
| 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 define a systematic approach for conducting Quality Assurance (QA) audits in ointment manufacturing. The QA audit ensures compliance with Good Manufacturing Practices (GMP), regulatory requirements, and internal quality standards.
2. Scope
This SOP applies to all personnel in the Quality Assurance (QA) and Compliance departments responsible for conducting internal and external audits of ointment manufacturing processes, facilities, equipment, and documentation.
3. Responsibilities
- QA Auditor: Conducts audits, identifies non-conformances, and prepares audit reports.
- Production Manager: Ensures manufacturing processes comply with GMP requirements.
- Quality Control (QC) Analyst: Supports QA audits by providing testing and laboratory documentation.
- Compliance Officer: Ensures regulatory requirements are met and oversees corrective actions.
- QA Manager: Reviews audit findings, approves reports, and monitors implementation of corrective actions.
4. Accountability
The QA Manager and Compliance Officer are accountable for ensuring that QA audits are conducted as per GMP and regulatory guidelines.
5. Procedure
5.1 Audit Planning
- Define the scope and objectives of the QA audit.
- Prepare an annual audit schedule covering all critical manufacturing processes.
- Identify audit criteria based on
GMP regulations and company policies.
Ensure that the audit team is trained and qualified.
5.2 Conducting the Audit
5.2.1 Facility and Equipment Inspection
- Verify that manufacturing areas comply with GMP cleanliness and safety standards.
- Check calibration and maintenance records of production equipment.
- Ensure that raw materials and finished products are stored as per defined conditions.
5.2.2 Process Compliance Audit
- Observe the adherence to standard operating procedures (SOPs).
- Review batch manufacturing records for completeness and accuracy.
- Verify in-process quality control checks and test result documentation.
5.2.3 Documentation and Record Review
- Ensure batch manufacturing records (BMR) and batch packaging records (BPR) are complete.
- Verify deviation reports and corrective actions taken.
- Ensure compliance with change control procedures.
5.2.4 Personnel Training and Hygiene
- Check that manufacturing personnel are trained as per regulatory requirements.
- Ensure hygiene and protective clothing standards are maintained.
- Verify documentation of training records.
5.3 Identifying Non-Conformances
- Classify audit findings into:
- Critical: Issues affecting patient safety or regulatory compliance.
- Major: Non-conformances that may impact product quality.
- Minor: Issues that require procedural improvements.
- Document all observations in the QA Audit Report.
5.4 Corrective and Preventive Actions (CAPA)
- Discuss audit findings with relevant department heads.
- Develop a Corrective and Preventive Action (CAPA) plan.
- Ensure that corrective actions address the root cause of non-conformances.
- Set timelines for implementing corrective measures.
5.5 Follow-Up and Audit Closure
- Perform a follow-up audit to verify corrective actions have been implemented.
- Close the audit once all non-conformances have been resolved.
- Ensure that audit records are stored for regulatory review.
6. Abbreviations
- GMP – Good Manufacturing Practices
- QA – Quality Assurance
- QC – Quality Control
- CAPA – Corrective and Preventive Action
- BMR – Batch Manufacturing Record
- BPR – Batch Packaging Record
7. Documents
- QA Audit Checklist (Annexure-1)
- QA Audit Report (Annexure-2)
8. References
- WHO GMP Guidelines for Pharmaceutical Manufacturing
- ICH Q9 – Quality Risk Management
- ICH Q10 – Pharmaceutical Quality System
9. SOP Version
Version 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: QA Audit Checklist
| Audit Area | Checklist Item | Compliant (Yes/No) | Remarks |
|---|---|---|---|
| Facility | Manufacturing area cleanliness | Yes | Compliant |
| Equipment | Calibration records available | Yes | Compliant |
| Documentation | BMR and BPR records complete | No | Missing entries |
Annexure-2: QA Audit Report
| Date | Audit Location | Audit Findings | Non-Conformance Level | Corrective Action | Status |
|---|---|---|---|---|---|
| 01/02/2025 | Ointment Manufacturing Area | Incomplete batch records | Major | Re-train operators | Open |
| 02/02/2025 | Filling Line | Equipment calibration overdue | Critical | Immediate recalibration | Closed |