Standard Operating Procedure for Sampling Plans for Finished Products in QA
| Department | Tablet |
|---|---|
| SOP No. | SOP/TAB/194/2025 |
| Supersedes | SOP/TAB/194/2022 |
| Page No. | Page 1 of 6 |
| Issue Date | 01/03/2026 |
| Effective Date | 06/03/2026 |
| Review Date | 01/03/2027 |
1. Purpose
To define the procedures for establishing and implementing sampling plans for finished products in Quality Assurance (QA), ensuring that the quality of the products is consistently verified through appropriate sample sizes and testing.
2. Scope
This SOP applies to all finished products manufactured within the tablet production facility. It covers the procedures for creating and executing sampling plans for in-process and final product testing in QA, ensuring compliance with regulatory standards.
3. Responsibilities
- Quality Assurance (QA): Responsible for overseeing the creation of sampling plans, ensuring that they comply with applicable regulatory standards and internal procedures. QA is also responsible for ensuring the accuracy and reliability of the sampling process.
- Production Team: Responsible for providing accurate batch records and coordinating with QA to implement sampling plans.
- Laboratory Personnel: Responsible for conducting the analysis on samples taken during production and ensuring that results are documented accurately.
4. Accountability
The QA Manager is accountable for the creation, implementation, and review of sampling plans for finished products. The Production Manager is responsible for ensuring the correct implementation of these sampling plans during production.
5. Procedure
5.1 Sampling Plan Creation
- The sampling plan should be based on the characteristics of the product and the risk associated with non-conformance. The size and frequency of sampling should be determined based on these factors.
- Sampling plans should specify the type of sample (e.g., composite or individual), the sample size, the frequency of sampling, and the method of sampling (Annexure-1).
- Ensure that the sampling plan complies with applicable regulatory guidelines (e.g., USP, ICH Q7) and internal quality control standards.
- The plan should include acceptance criteria for each quality attribute (e.g., content uniformity, dissolution, hardness) and establish the number of samples to be tested per batch.
5.2 Sampling Execution
- Once the sampling plan has been approved, the Production Team should coordinate with the QA team to execute the plan at appropriate intervals during the production process.
- Ensure that sampling is performed according to the plan at each stage of production, including raw material testing, in-process testing, and finished product testing (Annexure-2).
- Samples should be taken in a manner that avoids cross-contamination, and clean, calibrated tools should be used for sampling.
- Each sample should be properly labeled with relevant information such as batch number, product name, sampling date, and the person responsible for sampling.
5.3 Sample Handling and Analysis
- Once the samples are collected, they should be stored in a controlled environment to maintain their integrity until testing is performed.
- Ensure that all samples are analyzed according to the testing requirements specified in the sampling plan (e.g., identity testing, potency, dissolution, microbial testing, etc.).
- All analysis results should be recorded, and any deviations from the acceptance criteria must be documented, investigated, and corrected (Annexure-3).
- If any sample does not meet the specified criteria, QA must determine whether the entire batch should be rejected or reworked based on the severity of the non-conformance.
5.4 Documentation and Record Keeping
- Document all sampling activities, including the sampling plan, the results of the analysis, and any deviations from the plan.
- Maintain records of all sampling activities, including dates, batch numbers, sample identification numbers, and test results. These records should be readily available for audit or inspection (Annexure-4).
- Ensure that all records are maintained for a minimum of five years or as per regulatory requirements.
5.5 Sampling Plan Review and Revision
- Sampling plans should be reviewed periodically to ensure that they are still relevant and effective in ensuring the quality of the product.
- If changes in production processes, equipment, or raw materials occur, the sampling plan should be revised accordingly.
- Revised plans must be approved by QA before implementation, and all affected personnel should be trained on the updated procedures.
5.6 Corrective Actions
- If any deviations from the sampling plan are identified during the execution of the plan, corrective actions should be implemented immediately.
- Document all deviations and corrective actions taken. Any changes to the sampling plan should be recorded in the Revision History (Annexure-5).
6. Abbreviations
- SOP: Standard Operating Procedure
- QA: Quality Assurance
- GMP: Good Manufacturing Practice
- USP: United States Pharmacopeia
- ICH: International Council for Harmonisation
7. Documents
- Sampling Plan Template (Annexure-1)
- Sampling Record Log (Annexure-2)
- Analysis Report (Annexure-3)
- Sampling Deviation Log (Annexure-4)
- Sampling Plan Revision History (Annexure-5)
8. References
- USP <671> – Tablet Friability
- ICH Q7 – Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
- 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals (US FDA)
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Sampling Plan Template
| Sample ID | Product | Sample Size | Sampling Frequency | Acceptance Criteria |
|---|---|---|---|---|
| SMP-001 | Tablet A | 10 units | Every batch | 100% pass in dissolution |
Annexure-2: Sampling Record Log
| Batch Number | Sample ID | Sampling Date | Sampled By | Test Result |
|---|---|---|---|---|
| Batch-12345 | SMP-001 | 01/03/2026 | John Doe | Pass |
Annexure-3: Analysis Report
| Sample ID | Test Type | Test Results | Tested By |
|---|---|---|---|
| SMP-001 | Dissolution | Pass | Jane Smith |
Annexure-4: Sampling Deviation Log
| Deviation ID | Deviation Description | Corrective Action | Completion Date |
|---|---|---|---|
| DEV-001 | Incorrect sampling method used | Retrained personnel | 02/03/2026 |
Annexure-5: Sampling Plan 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 for finished products | Clarification of testing criteria | QA Head |
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 for finished products | Clarification of testing criteria | QA Head |