Procedure for Ensuring Consistent Filling Volume
| Department | Production/Quality Control (QC)/Quality Assurance (QA) |
|---|---|
| SOP No. | SOP/Ointment/077 |
| 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 the method for ensuring consistent filling volume in ointment packaging. Maintaining uniform filling volume is essential for dosage accuracy, product quality, 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 and verifying filling volume in ointment packaging.
3. Responsibilities
- Production Operator: Ensures the filling process adheres to predefined volume specifications.
- Production Supervisor: Monitors and verifies in-process filling volume checks.
- Quality Control Analyst: Conducts volume accuracy tests and records observations.
- Quality Assurance (QA) Personnel: Reviews and approves batch records for compliance.
4. Accountability
The Production, QC, and QA Managers are accountable for ensuring that filling volume consistency is maintained and documented as per regulatory requirements.
5. Procedure
5.1 Equipment and Materials
- Automatic or semi-automatic filling machine
- Calibrated weighing balance
- Graduated cylinders or volumetric pipettes
- Filling volume monitoring log
- Batch Manufacturing Record (BMR)
5.2 Pre-Filling Checks
- Ensure that the filling machine is calibrated according to the batch specifications.
- Verify that the correct nozzle size is used for filling.
- Ensure uniform temperature and viscosity of the ointment.
- Conduct a test fill using a reference container to check the volume before starting batch production.
5.3 Monitoring Filling Volume
5.3.1 In-Process Volume Checks
- Randomly sample filled containers at defined intervals (e.g., every 30 minutes).
- Weigh the filled container and compare it against the target volume.
- Alternatively, use a graduated cylinder to check volume accuracy.
- Ensure that variation does not exceed ±5% of the target volume.
5.3.2 Adjusting Filling Machine
- If underfilling or overfilling is detected, adjust the machine settings accordingly.
- Document any corrective actions taken.
- Re-check the filling volume after adjustments to ensure compliance.
5.4 Acceptance Criteria
- Each filled container should meet the predefined volume specification (e.g., 30 g ± 1 g).
- The filling variation should not exceed the defined acceptance limits.
- Rejected units due to volume deviations must be documented and investigated.
5.5 Post-Filling Verification
- Perform final volume checks before batch release.
- Ensure that all volume-related deviations have been resolved.
- QA personnel must review and approve batch records before shipment.
5.6 Documentation
- Record all filling volume tests in the Filling Volume Monitoring Log.
- Document all corrective actions if volume deviations occur.
- Ensure traceability by maintaining batch-wise records.
6. Abbreviations
- GMP – Good Manufacturing Practices
- QA – Quality Assurance
- QC – Quality Control
- BMR – Batch Manufacturing Record
7. Documents
- Filling Volume Monitoring Log (Annexure-1)
- Batch Filling 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: Filling Volume Monitoring Log
| Date | Batch Number | Sample ID | Target Volume | Observed Volume | Acceptance Criteria | Result | Verified By |
|---|---|---|---|---|---|---|---|
| 01/02/2025 | OINT-101 | SMP-001 | 30 g | 29.8 g | ±1 g | Pass | QA Officer |
| 01/02/2025 | OINT-102 | SMP-002 | 30 g | 30.2 g | ±1 g | Pass | QA Officer |
Annexure-2: Batch Filling Report
| Date | Batch Number | Filling Volume Test | Acceptance Criteria | Result | Final Status | Approved By |
|---|---|---|---|---|---|---|
| 01/02/2025 | OINT-101 | Volume Measurement | 30 g ± 1 g | 29.8 g | Approved | QA Head |
| 01/02/2025 | OINT-102 | Volume Measurement | 30 g ± 1 g | 30.2 g | Approved | 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 |