Procedure for Pilot Batch Production of Ointments
| Department | Production/Research and Development (R&D)/Quality Assurance |
|---|---|
| SOP No. | SOP/Ointment/019 |
| 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 outline the standardized method for the pilot batch production of ointments. This ensures that the formulation is reproducible, scalable, and meets quality and regulatory requirements before commercial manufacturing.
2. Scope
This SOP applies to the Research and Development (R&D) and Production departments responsible for the preparation, processing, and evaluation of pilot-scale batches of ointments.
3. Responsibilities
- Production Supervisor: Oversees the pilot batch production process.
- Formulation Scientist: Ensures the formulation is prepared as per defined parameters.
- Quality Control (QC) Analyst: Conducts in-process and final quality testing.
- Quality Assurance (QA) Officer: Verifies compliance with GMP standards.
- R&D Head: Reviews and approves pilot batch reports before scale-up.
4. Accountability
The Production and R&D Managers are accountable for ensuring that the pilot batch is produced under controlled conditions and that all records are maintained.
5. Procedure
5.1 Pre-Production Preparation
- Ensure all required raw materials and excipients are available and approved.
- Check the equipment for cleanliness and calibration.
- Review the Master Formula Record (MFR) and ensure all process parameters are defined.
- Assign batch number and document
all details in the Pilot Batch Manufacturing Record (BMR).
5.2 Weighing and Dispensing of Ingredients
- Weigh all active pharmaceutical ingredients (APIs) and excipients using a calibrated balance.
- Record the weighed quantities in the Weighing Log.
- Ensure proper labeling and identification of all materials.
5.3 Mixing and Heating Process
- Transfer base components (e.g., waxes, emulsifiers) into the heating vessel.
- Heat to the specified temperature while stirring continuously.
- Add APIs and other excipients under controlled conditions.
- Maintain temperature and mixing speed as per the validated parameters.
5.4 Homogenization and Cooling
- Use a homogenizer to ensure uniform distribution of ingredients.
- Gradually cool the batch to prevent crystallization.
- Monitor viscosity and pH at different cooling stages.
5.5 Sampling and In-Process Quality Control
- Take samples at predefined stages for analysis.
- Perform in-process checks including:
- pH measurement
- Viscosity analysis
- Homogeneity testing
- Microbial limit testing
- Ensure all test results comply with specified limits.
5.6 Filling and Packaging
- Fill the ointment into appropriate containers using a calibrated filling machine.
- Label and seal containers as per packaging specifications.
- Perform weight variation checks on filled units.
5.7 Final Quality Testing
- Submit finished samples to QC for final analysis.
- Conduct stability testing under accelerated and long-term conditions.
- Compare results with predefined acceptance criteria.
5.8 Documentation and Reporting
- Record all production and testing details in the Pilot Batch Manufacturing Record (BMR).
- Summarize findings in the Pilot Batch Report.
- Obtain approval from the R&D Head and QA before proceeding to commercial scale-up.
6. Abbreviations
- BMR – Batch Manufacturing Record
- MFR – Master Formula Record
- API – Active Pharmaceutical Ingredient
- QC – Quality Control
- QA – Quality Assurance
7. Documents
- Pilot Batch Manufacturing Record (Annexure-1)
- Pilot Batch Report (Annexure-2)
8. References
- WHO GMP Guidelines for Pharmaceutical Manufacturing
- ICH Q1A (R2) Stability Testing Guidelines
- 21 CFR Part 211 – Current Good Manufacturing Practices
9. SOP Version
Version 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Pilot Batch Manufacturing Record
| Date | Batch Number | Process Stage | Observation | Checked By |
|---|---|---|---|---|
| 01/02/2025 | SOP/Ointment/001 | Weighing | All materials weighed accurately | QA Officer |
| 02/02/2025 | SOP/Ointment/002 | Homogenization | Uniform distribution achieved | QA Officer |
Annexure-2: Pilot Batch Report
| Date | Batch Number | Parameter | Specification | Final Result | Final Status |
|---|---|---|---|---|---|
| 01/02/2025 | SOP/Ointment/001 | pH | 5.5-7.0 | 6.2 | Pass |
| 02/02/2025 | SOP/Ointment/002 | Viscosity | 1000-2000 cP | 1500 cP | 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 |