Standard Operating Procedure for Conducting Randomized Sampling of Capsules
Department | Capsule Manufacturing |
---|---|
SOP No. | SOP/CM/104/2025 |
Supersedes | SOP/CM/104/2022 |
Page No. | Page 1 of 6 |
Issue Date | 01/02/2025 |
Effective Date | 05/02/2025 |
Review Date | 01/02/2026 |
1. Purpose
The purpose of this SOP is to establish a standardized procedure for conducting randomized sampling of capsules. Randomized sampling ensures that the samples collected are representative of the entire batch, allowing for accurate quality control testing and ensuring the final product meets all quality specifications.
2. Scope
This SOP applies to the process of random sampling during the capsule manufacturing process. It covers the selection, collection, and handling of samples from the production batch for quality control testing.
3. Responsibilities
- Production Operators: Responsible for following the sampling procedure to collect samples from the production batch and ensuring proper labeling.
- Quality Control (QC) Team: Responsible for overseeing the randomized sampling process, ensuring the proper collection of samples, and conducting the necessary tests on the samples.
- Quality Assurance (QA) Team: Ensures that the sampling process is conducted according to the SOP and reviews the testing results to ensure that the batch meets quality specifications.
- Production Supervisor: Oversees the entire sampling process, ensures that proper sampling procedures are followed, and resolves any issues that arise during the sampling process.
4. Accountability
The Capsule Manufacturing Supervisor is accountable for ensuring that the randomized sampling is conducted according to this SOP. The QA Manager is responsible for reviewing and approving the sampling process and ensuring that the results are in compliance with quality standards.
5. Procedure
5.1 Sample Size Determination
Before collecting samples, determine the sample size based on the following:
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Determine Sample Size
- Calculate the appropriate sample size based on batch size, the expected variability of the product, and the level of confidence required for the testing.
- Consult standard sampling tables or quality control guidelines to determine the minimum number of samples required for the batch size.
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Confirm Sampling Requirements
- Ensure that the sample size is representative of the entire batch and that all critical quality attributes (e.g., size, weight, fill volume, appearance) will be covered in the sampling process.
- Ensure that the sampling plan adheres to industry standards or regulatory requirements for randomized sampling.
5.2 Randomized Sampling Process
Follow these steps to ensure that sampling is conducted randomly and represents the entire production batch:
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Ensure Random Selection
- Choose capsules randomly from different stages of the manufacturing process, ensuring that the selected capsules are representative of the entire batch.
- Do not select samples based on visual appearance to avoid selection bias.
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Collect the Samples
- Use clean and properly labeled sampling containers to collect the samples. Ensure that the capsules are not contaminated during the sampling process.
- Collect the samples from different locations in the batch, ensuring that they represent the entire manufacturing run.
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Record Sample Information
- Label each sample with the batch number, sampling time, and location. Ensure that the samples are stored in a clean, secure area until testing.
- Document all relevant details in the Sample Collection Log (Annexure-1), including the operator’s name, the time of sampling, and any other relevant observations.
5.3 Quality Control Testing
Once the samples have been collected, the following steps must be followed to test the capsules for compliance:
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Test the Samples
- QC will perform the necessary tests on the samples to evaluate the critical quality attributes, such as size, weight, fill volume, and appearance.
- Tests should be performed according to the predefined specifications for the capsules, ensuring that they meet the required standards.
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Analyze Test Results
- Analyze the test results to determine whether the capsules meet the established quality standards.
- If the results are within acceptable limits, the batch is deemed to pass the randomized sampling test and can proceed to the next stage of production.
- If the results are outside the acceptable limits, identify the cause of the deviation and take corrective actions.
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Document the Results
- Document all test results, including any deviations found, in the Sampling and Testing Report (Annexure-2).
- Ensure that all documentation is reviewed and signed by the responsible QC team member.
5.4 Handling Deviations and Corrective Actions
If the sampled capsules do not meet the quality specifications, follow these steps:
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Identify the Cause of Deviation
- Investigate the root cause of the deviation by reviewing the manufacturing process, materials, and equipment used during production.
- Consult with the production team to determine if any environmental factors, machine settings, or raw material issues contributed to the deviation.
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Implement Corrective Actions
- Take corrective actions, such as adjusting equipment settings, modifying the process, or addressing raw material issues, to prevent recurrence of the deviation.
- Retest the batch or affected samples after corrective actions are implemented to confirm that the issue has been resolved.
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Document the Deviation and Corrective Actions
- Record all deviations and corrective actions in the Deviation Log (Annexure-3) for future reference and regulatory compliance.
5.5 Final Approval and Release
Once the randomized sampling has been completed and any necessary corrective actions have been taken, the following steps must be taken:
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QA Review
- The QA team reviews the sampling results and corrective actions taken, ensuring that the batch meets the required quality specifications.
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Approval for Next Stage
- If the batch passes the randomized sampling and testing, the batch is approved for the next stage of production or packaging.
6. Abbreviations
- SOP: Standard Operating Procedure
- GMP: Good Manufacturing Practice
- QC: Quality Control
- QA: Quality Assurance
- BPR: Batch Production Record
7. Documents
- Sample Collection Log (Annexure-1)
- Sampling and Testing Report (Annexure-2)
- Deviation Log (Annexure-3)
8. References
- USP <1163> – Pharmaceutical Dosage Forms: Capsules
- FDA Guidelines for Capsule Manufacturing
- Good Manufacturing Practice (GMP) 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: Sample Collection Log
Sample ID | Sample Location | Sample Time | Collected By | Batch ID |
---|---|---|---|---|
Sample 001 | Line 1 | 10:00 AM | John Doe | Batch 001 |
Sample 002 | Line 2 | 10:15 AM | Jane Smith | Batch 001 |
Annexure-2: Sampling and Testing Report
Sample ID | Test Parameter | Test Result | Deviations | Corrective Action |
---|---|---|---|---|
Sample 001 | Capsule Weight | 500 mg | No | None |
Sample 002 | Fill Volume | Standard | No | None |
Annexure-3: Deviation Log
Deviation ID | Batch ID | Description | Corrective Action | Operator | Approval Status |
---|---|---|---|---|---|
DEV-001 | Batch 001 | Capsule weight outside acceptable range | Recalibrated machine | John Doe | Approved |
Revision History:
Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
---|---|---|---|---|
01/01/2024 | 1.0 | Initial Version | New SOP Creation | QA Head |
01/02/2025 | 2.0 | Updated sampling procedures and documentation | Standardization | QA Head |