Procedure for Ensuring Batch Uniformity in Ointments
| Department | Production/Quality Control (QC)/Quality Assurance (QA) |
|---|---|
| SOP No. | SOP/Ointment/074 |
| 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 ensuring batch uniformity in ointment manufacturing. Uniformity in batch production is critical for consistency, efficacy, and compliance with Good Manufacturing Practices (GMP).
2. Scope
This SOP applies to all personnel in the Production, Quality Control (QC), and Quality Assurance (QA) departments responsible for monitoring, testing, and verifying batch uniformity during ointment manufacturing.
3. Responsibilities
- Production Operator: Ensures that all mixing and blending procedures are followed accurately.
- Production Supervisor: Monitors batch processes and verifies uniformity checks.
- Quality Control Analyst: Conducts physical, chemical, and microbiological tests to confirm uniformity.
- Quality Assurance (QA) Personnel: Reviews batch records and approves release based on uniformity compliance.
4. Accountability
The Production, QC, and QA Managers are accountable for ensuring that batch uniformity is maintained and documented as per regulatory standards.
5. Procedure
5.1 Equipment and Materials
- Mixing tanks with agitators
- Viscometer
- pH meter
- Sampling containers
- High-Performance Liquid Chromatography (HPLC) system
- Microbiological testing kits
- Batch Manufacturing Record (BMR)
5.2 Pre-Manufacturing Checks
- Ensure all raw materials meet specification requirements.
- Verify mixing equipment calibration and functionality.
- Ensure accurate weighing and dispensing of raw materials.
- Review Batch Manufacturing Record (BMR) for compliance.
5.3 Monitoring Batch Uniformity
5.3.1 Mixing and Blending
- Start mixing at the defined speed and duration as per the batch process.
- Monitor temperature and viscosity at intervals to ensure uniform blending.
- Perform in-process sampling to check consistency.
- Ensure that phase separation does not occur.
5.3.2 In-Process Sampling
- Collect samples from different points in the mixing vessel.
- Ensure sampling from the top, middle, and bottom layers.
- Analyze pH, viscosity, and active ingredient content.
5.3.3 Testing for Uniformity
- Perform HPLC or UV spectrophotometry for active ingredient uniformity.
- Check for microbial contamination as per batch release requirements.
- Ensure the final product meets viscosity and spreadability standards.
5.4 Acceptance Criteria
- Active ingredient content must be within ±5% of the target value.
- pH variation should not exceed 0.5 units from the defined range.
- Viscosity should remain within predefined limits.
- No phase separation or foreign particles should be observed.
5.5 Documentation
- Record all uniformity test results in the Batch Uniformity Log.
- Document all corrective actions if uniformity deviations occur.
- QA personnel must review and approve batch records before release.
6. Abbreviations
- GMP – Good Manufacturing Practices
- QA – Quality Assurance
- QC – Quality Control
- BMR – Batch Manufacturing Record
- HPLC – High-Performance Liquid Chromatography
7. Documents
- Batch Uniformity Log (Annexure-1)
- Batch Release Report (Annexure-2)
8. References
- WHO GMP Guidelines for Pharmaceutical Manufacturing
- USP <905> – Uniformity of Dosage Units
- ICH Q6A – Specifications: Test Procedures and Acceptance Criteria
9. SOP Version
Version 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Batch Uniformity Log
| Date | Batch Number | Sample Location | Active Ingredient (%) | pH | Viscosity | Result | Verified By |
|---|---|---|---|---|---|---|---|
| 01/02/2025 | OINT-101 | Top | 98.5% | 6.3 | 45,000 cP | Pass | QA Officer |
| 01/02/2025 | OINT-101 | Middle | 98.8% | 6.4 | 45,500 cP | Pass | QA Officer |
| 01/02/2025 | OINT-101 | Bottom | 98.2% | 6.3 | 44,900 cP | Pass | QA Officer |
Annexure-2: Batch Release Report
| Date | Batch Number | Uniformity Test | Acceptance Criteria | Result | Final Status | Approved By |
|---|---|---|---|---|---|---|
| 01/02/2025 | OINT-101 | HPLC Assay | 95% – 105% | 98.5% | Approved | QA Head |
| 01/02/2025 | OINT-101 | pH Measurement | 6.0 – 6.5 | 6.3 | Approved | QA Head |