Procedure for Ensuring Proper Batch Size in Each Stage
| Department | Production/Quality Assurance (QA)/Research and Development (R&D) |
|---|---|
| SOP No. | SOP/Ointment/039 |
| 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 proper batch size at each stage of ointment manufacturing. Maintaining consistent batch size ensures product uniformity, process efficiency, and compliance with regulatory requirements.
2. Scope
This SOP applies to all personnel involved in batch size determination, verification, and adjustment during the ointment manufacturing process.
3. Responsibilities
- Production Supervisor: Ensures batch sizes adhere to formulation guidelines.
- Machine Operator: Monitors and adjusts equipment settings to maintain batch consistency.
- Quality Assurance (QA) Personnel: Verifies batch size compliance with GMP standards.
- R&D Scientist: Defines acceptable batch size ranges for each process stage.
4. Accountability
The Production and QA Managers are accountable for ensuring that batch size determination is conducted as per GMP standards and properly documented.
5. Procedure
5.1 Determining Batch Size
- Refer to the Batch Manufacturing Record (BMR) for the defined batch size.
- Verify availability of raw materials to meet batch requirements.
- Confirm equipment capacity aligns with the prescribed batch volume.
5.2 Ensuring Proper Batch Size at Different Stages
5.2.1 Raw Material Dispensing
- Weigh
each raw material precisely using calibrated balances.
Ensure all weighed materials match the defined batch size.
Record actual weight and verify against target values.
5.2.2 Mixing and Emulsification
- Ensure correct proportions of active ingredients, excipients, and base materials.
- Adjust mixing vessel volume to prevent overflow or underfilling.
- Verify uniform dispersion before proceeding to the next stage.
5.2.3 Cooling and Solidification
- Monitor batch size to prevent loss due to evaporation or spills.
- Adjust cooling vessel capacity to accommodate full batch volume.
- Ensure no batch reduction due to excessive processing time.
5.2.4 Filling and Packaging
- Check for uniform batch division before transferring to the filling machine.
- Ensure final batch yield matches expected output after filling.
- Document any batch variations and report to QA for approval.
5.3 Handling Batch Size Deviations
- If batch size exceeds or falls below the allowable limit, halt production.
- Identify the cause (e.g., ingredient miscalculation, equipment error).
- Implement corrective actions and document in the Batch Size Deviation Log.
5.4 Documentation and Approval
- Record batch size measurements in the Batch Size Monitoring Log.
- QA must review and approve batch records before release.
- Retain batch size data for audit and compliance purposes.
6. Abbreviations
- GMP – Good Manufacturing Practices
- QA – Quality Assurance
- QC – Quality Control
- BMR – Batch Manufacturing Record
- R&D – Research and Development
7. Documents
- Batch Size Monitoring Log (Annexure-1)
- Batch Size Deviation 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: Batch Size Monitoring Log
| Date | Batch Number | Stage | Target Batch Size (Kg) | Actual Batch Size (Kg) | Verified By |
|---|---|---|---|---|---|
| 01/02/2025 | SOP/Ointment/001 | Mixing | 100 | 98 | QA Officer |
| 02/02/2025 | SOP/Ointment/002 | Filling | 100 | 101 | QA Officer |
Annexure-2: Batch Size Deviation Log
| Date | Batch Number | Stage | Deviation | Corrective Action | Approved By |
|---|---|---|---|---|---|
| 02/02/2025 | SOP/Ointment/002 | Mixing | Batch volume reduced by 2% | Adjusted raw material ratio | QA Head |
| 03/02/2025 | SOP/Ointment/003 | Filling | Overfill by 1% | Calibrated filling machine | 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 |