Procedure for Preventing Contamination at Each Stage
| Department | Production/Quality Assurance (QA)/Quality Control (QC) |
|---|---|
| SOP No. | SOP/Ointment/040 |
| 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 for preventing contamination at each stage of ointment manufacturing. Proper contamination control ensures product safety, maintains GMP compliance, and prevents cross-contamination.
2. Scope
This SOP applies to all personnel involved in the manufacturing, handling, storage, and transfer of materials within the ointment production facility.
3. Responsibilities
- Production Supervisor: Ensures adherence to contamination control measures.
- Machine Operator: Follows hygiene protocols and cleaning procedures.
- Quality Assurance (QA) Personnel: Conducts environmental monitoring and compliance checks.
- Engineering Technician: Maintains and sanitizes equipment as per the cleaning schedule.
4. Accountability
The Production and QA Managers are accountable for ensuring that contamination control is implemented as per GMP standards and properly documented.
5. Procedure
5.1 Contamination Control Measures
- Implement a cleanroom policy with restricted access.
- Ensure personnel follow gowning procedures before entering manufacturing areas.
- Maintain proper air filtration and ventilation systems.
5.2 Preventing Contamination at Different Stages
5.2.1 Raw Material Handling
- Ensure raw materials are received in contamination-free packaging.
- Verify raw material quality before use.
- Store materials in designated clean areas.
5.2.2 Mixing and Emulsification
- Ensure all mixing vessels and equipment are cleaned before use.
- Maintain closed systems to prevent airborne contamination.
- Monitor environmental conditions (temperature, humidity, airflow).
5.2.3 Cooling and Storage
- Use sealed containers to prevent microbial growth.
- Regularly clean storage tanks and ensure no residue buildup.
- Keep the manufacturing area free from dust and debris.
5.2.4 Filling and Packaging
- Maintain sterile conditions during filling operations.
- Ensure operators wear gloves and masks during handling.
- Inspect packaging for defects that may cause contamination.
5.3 Handling Contamination Incidents
- If contamination is detected, immediately halt production.
- Isolate the affected batch and conduct a root cause analysis.
- Implement corrective and preventive actions (CAPA) and document in the Contamination Incident Log.
5.4 Documentation and Approval
- Record all contamination control measures in the Contamination Prevention Log.
- QA must review and approve contamination reports.
- Maintain records for regulatory inspections.
6. Abbreviations
- GMP – Good Manufacturing Practices
- QA – Quality Assurance
- QC – Quality Control
- CAPA – Corrective and Preventive Action
7. Documents
- Contamination Prevention Log (Annexure-1)
- Contamination Incident Log (Annexure-2)
8. References
- WHO GMP Guidelines for Pharmaceutical Manufacturing
- 21 CFR Part 211 – Current Good Manufacturing Practices
- ICH Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
9. SOP Version
Version 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Contamination Prevention Log
| Date | Batch Number | Stage | Preventive Measure | Verified By |
|---|---|---|---|---|
| 01/02/2025 | SOP/Ointment/001 | Mixing | Air filtration verified | QA Officer |
| 02/02/2025 | SOP/Ointment/002 | Filling | Operator gloves changed | QA Officer |
Annexure-2: Contamination Incident Log
| Date | Batch Number | Stage | Contamination Type | Corrective Action | Approved By |
|---|---|---|---|---|---|
| 03/02/2025 | SOP/Ointment/003 | Mixing | Microbial growth detected | Equipment sterilized | QA Head |
| 04/02/2025 | SOP/Ointment/004 | Filling | Particulate matter observed | Batch 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 |