Procedure for Maintaining GMP Standards
| Department | Quality Assurance (QA)/Production/Quality Control (QC) |
|---|---|
| SOP No. | SOP/Ointment/089 |
| 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 systematic approach to maintaining Good Manufacturing Practices (GMP) in ointment manufacturing. GMP ensures that products are consistently produced and controlled to meet quality standards and regulatory requirements.
2. Scope
This SOP applies to all personnel in the Production, Quality Assurance (QA), and Quality Control (QC) departments responsible for implementing and maintaining GMP standards in the manufacturing facility.
3. Responsibilities
- Production Operator: Ensures GMP compliance during manufacturing processes.
- Production Supervisor: Monitors GMP adherence and provides necessary training.
- QC Analyst: Conducts tests to verify GMP compliance.
- QA Officer: Conducts GMP audits and ensures regulatory adherence.
- QA Manager: Approves GMP policies and oversees implementation.
4. Accountability
The QA and Production Managers are accountable for ensuring that GMP standards are implemented, followed, and continuously improved.
5. Procedure
5.1 General GMP Requirements
- Ensure all manufacturing processes follow written and approved SOPs.
- Maintain clean and controlled production environments.
- Ensure proper documentation practices (Good Documentation Practices, GDP).
5.2 Facility and Equipment Compliance
- Keep production areas free from contamination and cross-contamination risks.
- Ensure regular maintenance and calibration of equipment.
- Document equipment cleaning and maintenance activities.
5.3 Personnel Hygiene and Training
- Ensure all personnel wear appropriate protective clothing.
- Maintain personal hygiene to prevent product contamination.
- Provide regular GMP training for all employees.
5.4 Material Handling and Storage
- Ensure raw materials and finished products are stored under proper conditions.
- Label all materials correctly to prevent mix-ups.
- Use a First-In-First-Out (FIFO) or First-Expiry-First-Out (FEFO) system.
5.5 Manufacturing Process Controls
- Monitor and document critical process parameters.
- Ensure in-process quality control checks are performed.
- Address deviations through corrective and preventive actions (CAPA).
5.6 Cleaning and Sanitation
- Follow approved cleaning procedures for all equipment and areas.
- Use validated cleaning agents and ensure proper documentation.
- Perform regular environmental monitoring.
5.7 Documentation and Record Keeping
- Maintain batch manufacturing records (BMR) and batch packaging records (BPR).
- Document all deviations and investigations.
- Ensure traceability of all processes and materials.
5.8 Internal Audits and Continuous Improvement
- Conduct regular GMP audits to identify compliance gaps.
- Implement corrective actions based on audit findings.
- Review GMP policies periodically for updates.
6. Abbreviations
- GMP – Good Manufacturing Practices
- QA – Quality Assurance
- QC – Quality Control
- BMR – Batch Manufacturing Record
- BPR – Batch Packaging Record
- CAPA – Corrective and Preventive Action
7. Documents
- GMP Compliance Checklist (Annexure-1)
- GMP Audit Report (Annexure-2)
8. References
- WHO GMP Guidelines for Pharmaceutical Manufacturing
- ICH Q7 – Good Manufacturing Practice Guide
- 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: GMP Compliance Checklist
| GMP Area | Compliance Item | Compliant (Yes/No) | Remarks |
|---|---|---|---|
| Facility | Clean and contamination-free | Yes | Compliant |
| Equipment | Calibration records up to date | Yes | Compliant |
| Documentation | BMR and BPR records complete | No | Missing entries |
Annexure-2: GMP 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 |
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 |