Standard Operating Procedure for Sampling Plan for In-Process Tablet Testing

Department	Quality Control
SOP No.	SOP/TAB/130/2025
Supersedes	SOP/TAB/130/2022
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 procedure for selecting representative tablet samples during the in-process testing stage to ensure the quality and consistency of tablets throughout the manufacturing process.

2. Scope

This SOP applies to the sampling plan for in-process testing of tablets during production. It ensures that samples are taken at appropriate intervals to evaluate the critical quality attributes of tablets.

3. Responsibilities

• Quality Control (QC): Responsible for executing the sampling plan, collecting representative samples, and conducting tests on the selected samples.
• Production Operator: Responsible for providing samples at the appropriate times during the production process and ensuring the tablets are appropriately handled for testing.
• Quality Assurance (QA): Ensures that the sampling process follows this SOP and reviews the results for compliance with specifications.

4. Accountability

The QC Manager is accountable for ensuring the correct implementation of this sampling plan. The QA Manager is responsible for reviewing and ensuring the accuracy of the sampling and testing processes.

5. Procedure

5.1 Sampling Frequency

1. Samples should be taken at predetermined intervals throughout the production process, such as after every 100 tablets, or at significant stages of production (e.g., after compression, coating, etc.).
2. Sampling should also be done whenever there is a process change or after any deviation from normal conditions to verify consistency.
3. Sample size should be statistically representative of the entire batch. A minimum of 10 tablets should be sampled per interval for most tests (e.g., hardness, weight variation, disintegration).

5.2 Sample Collection Procedure

1. Collect samples from the middle, beginning, and end of the batch to ensure representation from all parts of the batch.
2. For each sampling interval, collect a minimum of 10 tablets, ensuring that the tablets are not damaged during the collection process.
3. Label each sample clearly with the sample number, batch number, time of collection, and the operator’s name for traceability.
4. If automated systems are used for sample collection, ensure that the systems are calibrated, and the samples are properly logged and tracked.

5.3 Testing of Samples

1. Test the collected samples for critical quality attributes such as hardness, weight variation, disintegration time, and dissolution, based on the in-process requirements for the specific batch.
2. If any of the test results fall outside the acceptable limits, further investigation must be conducted, and corrective actions should be taken.
3. Document the results of each test and compare them against the acceptance criteria for each quality attribute.

5.4 Adjustments Based on Results

1. If the in-process testing results do not meet specifications (e.g., for hardness or weight variation), notify the production operator immediately to adjust the production process.
2. Adjustments may include modifying compression force, changing the tablet press speed, or adjusting the granulation process to achieve the desired tablet attributes.
3. Re-sample and re-test after adjustments have been made to confirm that the process is back within specification.

5.5 Documentation

1. Record the details of each sample, including the sample number, collection time, results of the tests performed, and any deviations or corrective actions taken in the batch record (Annexure-2).
2. All test results and corrective actions should be documented and reviewed by QA to ensure compliance.

5.6 Acceptance Criteria

1. The collected samples should meet the required specifications for each quality attribute (e.g., hardness, weight variation, disintegration time) within predefined acceptable limits.
2. If any sample results fall outside the specified limits, the batch may need to be adjusted or rejected depending on the severity of the deviation.

5.7 Post-Sampling Actions

1. Once the samples are collected, proceed with the next stages of tablet manufacturing if the results meet the required specifications. If any deviations are found, rework the batch or take corrective actions before proceeding.
2. Ensure that the equipment used for sampling is cleaned and calibrated as required before the next sampling session.

6. Abbreviations

• SOP: Standard Operating Procedure
• GMP: Good Manufacturing Practice
• QC: Quality Control
• QA: Quality Assurance
• API: Active Pharmaceutical Ingredient

7. Documents

1. Batch Record (Annexure-2)
2. Deviation Report (Annexure-1)

8. References

• USP <905> – Content Uniformity
• 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals (US FDA)
• European Pharmacopoeia (EP) – Tablet Quality Control 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: Deviation Report

Deviation Date	Batch Number	Deviation Description	Corrective Action	Responsible Person
15/12/2025	Batch 001	Hardness below target specification	Adjusted compression force	John Doe

Annexure-2: Batch Record

Sample Number	Test Result	Action Taken
Sample 1	Pass	Accepted

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 plan and frequency	Improved monitoring processes	QA Head