Procedure for Homogeneity Testing at Different Stages
| Department | Quality Control (QC)/Quality Assurance (QA)/Production |
|---|---|
| SOP No. | SOP/Ointment/036 |
| 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 process for homogeneity testing at different stages of ointment manufacturing. Homogeneity testing ensures uniform distribution of active ingredients, consistency, and quality compliance.
2. Scope
This SOP applies to all ointment batches produced in the manufacturing facility, covering pre-mixing, final mixing, cooling, and filling stages.
3. Responsibilities
- Production Supervisor: Ensures samples are collected at required intervals.
- QC Analyst: Conducts homogeneity testing as per batch specifications.
- QA Personnel: Reviews test results and ensures compliance with GMP standards.
- R&D Scientist: Defines homogeneity testing parameters for each formulation.
4. Accountability
The QA and QC Managers are accountable for ensuring that homogeneity testing is conducted as per GMP standards and properly documented.
5. Procedure
5.1 Sampling for Homogeneity Testing
- Collect representative samples from different parts of the batch:
- Top
- Middle
- Bottom
- Edges of the mixing vessel
- Ensure aseptic handling of samples to avoid contamination.
- Label samples with batch number, sampling location, and stage.
5.2 Homogeneity Testing at Different Stages
5.2.1 Pre-Mixing Stage
- Verify uniform dispersion of active ingredients before heating.
- Perform visual inspection for any signs of separation.
- Check the initial viscosity of the batch.
5.2.2 Final Mixing Stage
- Perform pH and viscosity testing to confirm uniformity.
- Check for particle size distribution using a suitable analyzer.
- Compare test results with pre-defined batch specifications.
5.2.3 Cooling Stage
- Check for phase separation or crystallization.
- Perform homogeneity testing for emulsions.
- Ensure uniform consistency across all sampling locations.
5.2.4 Filling Stage
- Test for weight variation to ensure uniform filling.
- Analyze random filled containers to confirm content uniformity.
- Perform final physical and chemical analysis before batch release.
5.3 Acceptance Criteria for Homogeneity
- Active ingredient distribution should be within ±5% of the target concentration.
- pH and viscosity must match the batch specification.
- No signs of phase separation, air entrapment, or inconsistencies.
- Test results should comply with pharmacopeial requirements (USP, BP, IP).
5.4 Documentation and Approval
- Record test results in the Homogeneity Test Log.
- QA must verify and approve homogeneity before batch release.
- Retain test samples for stability analysis if required.
6. Abbreviations
- GMP – Good Manufacturing Practices
- QA – Quality Assurance
- QC – Quality Control
- USP – United States Pharmacopeia
- BP – British Pharmacopeia
- IP – Indian Pharmacopeia
7. Documents
- Homogeneity Test Log (Annexure-1)
- In-Process Quality Control Report (Annexure-2)
8. References
- WHO GMP Guidelines for Pharmaceutical Manufacturing
- 21 CFR Part 211 – Current Good Manufacturing Practices
- USP/BP/IP Standard Test Methods
9. SOP Version
Version 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Homogeneity Test Log
| Date | Batch Number | Sampling Location | Test Parameter | Specification | Result | Verified By |
|---|---|---|---|---|---|---|
| 01/02/2025 | SOP/Ointment/001 | Top | Active Ingredient % | 95-105% | 98% | QA Officer |
| 02/02/2025 | SOP/Ointment/002 | Bottom | pH | 5.5-7.0 | 6.3 | QA Officer |
Annexure-2: In-Process Quality Control Report
| Date | Batch Number | Stage | Test Parameter | Specification | Result | Final Status |
|---|---|---|---|---|---|---|
| 01/02/2025 | SOP/Ointment/001 | Final Mixing | Viscosity | 1000-2000 cP | 1500 cP | Pass |
| 02/02/2025 | SOP/Ointment/002 | Cooling | Phase Separation | None | None | Pass |
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 |