Standard Operating Procedure for Capsule Weight Variation Testing
| Department | Capsule Manufacturing |
|---|---|
| SOP No. | SOP/CM/182/2025 |
| Supersedes | SOP/CM/182/2022 |
| Page No. | Page 1 of 9 |
| Issue Date | 01/02/2025 |
| Effective Date | 05/02/2025 |
| Review Date | 01/02/2026 |
1. Purpose
The purpose of this SOP is to define the procedure for performing weight variation testing on capsules. Capsule weight variation testing is critical for ensuring uniformity in the weight of capsules, which is essential for ensuring the correct dosage of the active pharmaceutical ingredients (APIs) and excipients. This SOP ensures that capsule weight meets the defined standards and complies with regulatory requirements.
2. Scope
This SOP applies to the testing of capsule weight variation during the manufacturing process. It covers the sampling procedure, testing methods, and criteria for determining whether the capsules comply with the weight variation limits. The SOP is applicable to both soft and hard gelatin capsules.
3. Responsibilities
- Quality Control (QC) Team: Responsible for performing the weight variation tests on the capsules, ensuring that samples are representative, and documenting the results accurately. QC is also responsible for identifying capsules that do not meet the weight variation standards.
- Quality Assurance (QA) Team: Responsible for reviewing and approving the weight variation test criteria, methods, and ensuring that the process complies with GMP and regulatory standards.
- Production Team: Responsible for ensuring that capsules are sampled for weight variation testing at the appropriate stages of production and that corrective actions are implemented when deviations are detected.
- Supervisory Personnel: Responsible for overseeing the testing procedure and ensuring that operators and inspectors are trained to perform weight variation testing according to the SOP.
4. Accountability
The QA Manager is accountable for ensuring the validation of the weight variation testing procedure and ensuring that it is compliant with regulatory requirements. The QC Supervisor is responsible for the execution of weight variation testing, including the proper collection of samples and documentation of results. The Production Supervisor ensures that capsules are appropriately sampled for testing during production and that corrective actions are taken when necessary.
5. Procedure
5.1 Pre-Testing Setup
Before performing weight variation testing, ensure the following steps are completed:
-
Review Weight Variation Criteria
- Review the weight variation acceptance criteria, which should align with regulatory requirements (e.g., USP or ICH guidelines). The weight variation limits must be approved by the QA department before testing.
-
Prepare Testing Area
- Ensure that the testing area is clean, organized, and equipped with calibrated balance scales that meet the required precision standards. The scales should be calibrated according to the manufacturer’s instructions, and calibration details must be documented in the Equipment Calibration Log (Annexure 1).
-
Prepare Sample Collection Plan
- Define the sampling plan, including the number of capsules to be tested. Typically, a representative sample of 20 capsules is taken from the batch. The sample must be randomly selected to ensure that it accurately represents the full batch.
5.2 Weight Variation Testing Procedure
Follow these steps to perform the weight variation testing:
-
Sample Capsule Selection
- Select 20 capsules randomly from the batch as per the sampling plan. The capsules should be sampled from different parts of the batch to avoid bias.
-
Weighing Capsules
- Weigh each capsule individually using a calibrated analytical balance. Ensure that the balance is set to zero before weighing each capsule. Record the weight of each capsule in the Capsule Weight Log (Annexure 2).
-
Calculate Average Weight
- Calculate the average weight of the 20 sampled capsules. The average weight is determined by adding the individual weights and dividing by 20.
-
Calculate Weight Variation
- Calculate the weight variation for each capsule by comparing the individual weight to the average weight. The individual weight variation should not exceed the prescribed limits defined by the applicable regulatory guidelines.
-
Evaluate Results
- If more than two capsules are outside the allowable weight variation limits, or if the average weight exceeds the acceptable deviation from the mean, the batch should be considered non-compliant. Record these findings and notify the production team for corrective action.
-
Document Results
- Document all weight variation test results in the Capsule Weight Variation Testing Log (Annexure 3). Include the capsule batch number, the weights of the individual capsules, the average weight, and any deviations noted.
5.3 Post-Testing Activities
After the weight variation testing is complete, ensure the following actions are taken:
-
Review Test Results
- The QA Manager reviews the weight variation test results to confirm that they meet the predefined acceptance criteria. If necessary, initiate further investigation or root cause analysis for deviations.
-
Corrective Actions
- If weight variations are detected, the Production Supervisor must implement corrective actions, such as adjusting the filling process or equipment calibration, to prevent recurrence.
-
Training and Feedback
- Provide additional training to operators or technicians if errors in the process are found to be the root cause of the weight variations. Feedback should be given to improve the process.
-
Record Keeping
- Ensure that all weight variation testing records, including the testing log, batch details, and corrective action reports, are properly filed and stored in accordance with regulatory and company requirements.
6. Abbreviations
- SOP: Standard Operating Procedure
- GMP: Good Manufacturing Practice
- QA: Quality Assurance
- QC: Quality Control
- RH: Relative Humidity
7. Documents
- Annexure 1: Equipment Calibration Log
- Annexure 2: Capsule Weight Log
- Annexure 3: Capsule Weight Variation Testing Log
8. References
- FDA Guidance on Capsule Weight Variation Testing
- Good Manufacturing Practice (GMP) Guidelines
- USP <711> – Dissolution Testing
- ICH Q6A – Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure 1: Equipment Calibration Log
| Equipment ID | Calibration Date | Operator | Calibration Details | Next Calibration Due |
|---|---|---|---|---|
| Capsule Scale 302 | 01/02/2025 | John Doe | Calibration of precision balance | 01/02/2026 |
Annexure 2: Capsule Weight Log
| Capsule ID | Weight (mg) | Operator | Test Date | Remarks |
|---|---|---|---|---|
| Batch 001 | 500 | Jane Smith | 02/02/2025 | Standard weight |
Annexure 3: Capsule Weight Variation Testing Log
| Batch ID | Test Date | Capsule Weight (mg) | Average Weight (mg) | Weight Variation (%) | Result |
|---|---|---|---|---|---|
| Batch 001 | 02/02/2025 | 499 | 500 | 0.2% | Pass |
12. Revision History
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 01/01/2024 | 1.0 | Initial version of SOP | Creation of SOP for capsule weight variation testing | QA Head |
| 01/02/2025 | 2.0 | Updated weight variation acceptance criteria | Enhancement of testing parameters | QA Head |