Procedure for Preparing a Trial Batch of Ointments
| Department | Research and Development (R&D)/Quality Assurance |
|---|---|
| SOP No. | FD-012 |
| 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 standardized method for preparing a trial batch of ointments in the Research and Development (R&D) department. This process ensures the reproducibility, stability, and effectiveness of the formulation before scaling up to pilot production.
2. Scope
This SOP applies to the R&D team responsible for preparing and evaluating trial batches of ointments. It covers ingredient weighing, mixing, heating, cooling, and documentation of batch preparation.
3. Responsibilities
- Formulation Scientist: Responsible for the preparation of the trial batch and ensuring adherence to the formulation protocol.
- Analytical Chemist: Conducts testing and analysis on the trial batch.
- Quality Assurance (QA) Personnel: Verifies compliance with formulation and process parameters.
- R&D Head: Reviews and approves trial batch reports before further development.
4. Accountability
The R&D Manager is accountable for ensuring that the trial batch is prepared under controlled conditions and that all results are documented accurately.
5. Procedure
5.1 Pre-Batch Preparations
- Ensure all raw materials are approved and available in the required quantities.
- Verify that all necessary equipment, including weighing balances,
mixers, and heating apparatus, are calibrated.
Prepare a Batch Manufacturing Record (BMR) for the trial batch.
5.2 Weighing of Ingredients
- Weigh all raw materials as per the batch formula using a calibrated balance.
- Record the actual weights in the Trial Batch Weighing Log.
- Ensure all materials are labeled and segregated before processing.
5.3 Mixing and Heating
- Transfer base ingredients (such as emulsifiers and waxes) into a heating vessel.
- Heat the mixture to the specified temperature, ensuring uniform melting.
- Incorporate active pharmaceutical ingredients (APIs) into the heated base while stirring continuously.
- Use a homogenizer if required to ensure uniform dispersion.
5.4 Cooling and Final Mixing
- Gradually cool the batch while stirring at a controlled speed.
- Monitor viscosity and texture changes during cooling.
- Adjust pH, if required, to meet product specifications.
- Perform initial physical inspections, including spreadability and homogeneity tests.
5.5 Sampling and Testing
- Take representative samples for physical and microbiological analysis.
- Conduct pH, viscosity, spreadability, and stability tests.
- Record all test results in the Trial Batch Evaluation Log.
5.6 Documentation and Reporting
- Complete the Batch Manufacturing Record (BMR) with all observations.
- Prepare a Trial Batch Report, including formulation details, test results, and deviations.
- Obtain approval from the R&D Head before proceeding with further optimization or pilot batch production.
6. Abbreviations
- BMR – Batch Manufacturing Record
- API – Active Pharmaceutical Ingredient
- QA – Quality Assurance
- R&D – Research and Development
7. Documents
- Trial Batch Weighing Log (Annexure-1)
- Trial Batch Evaluation Log (Annexure-2)
8. References
- WHO GMP Guidelines for Pharmaceutical Manufacturing
- 21 CFR Part 211 – Current Good Manufacturing Practices
- ICH Q8(R2) Pharmaceutical Development Guidelines
9. SOP Version
Version 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Trial Batch Weighing Log
| Date | Batch Number | Material Name | Weighed Quantity (g) | Weighed By | Verified By |
|---|---|---|---|---|---|
| 01/02/2025 | TB-001 | API-A | 10.00 | John Doe | QA Officer |
| 02/02/2025 | TB-002 | Emulsifier | 5.00 | Jane Smith | QA Officer |
Annexure-2: Trial Batch Evaluation Log
| Date | Batch Number | Test Parameter | Specification | Result | Verified By |
|---|---|---|---|---|---|
| 01/02/2025 | TB-001 | Viscosity | 1000-2000 cP | 1500 cP | QA Officer |
| 02/02/2025 | TB-002 | pH | 5.5-7.0 | 6.2 | QA Officer |
12. Revision History:
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By | Page No. | Ref. Point No. | Details of Revision |
|---|---|---|---|---|---|---|---|
| 01/01/2024 | 1.0 | Initial Version | New SOP | QA Head | All | All | Created new SOP |
| 01/02/2025 | 2.0 | Updated SOP Format | Standardization of Document | QA Head | All | All | Revised to meet new documentation standards |