Capsule: SOP for Sampling In-Process Capsules for Quality Checks – V 2.0

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Capsule: SOP for Sampling In-Process Capsules for Quality Checks – V 2.0

Standard Operating Procedure for Sampling In-Process Capsules for Quality Checks

Department Capsule Manufacturing
SOP No. SOP/CM/057/2025
Supersedes SOP/CM/057/2022
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 outline the procedure for sampling in-process capsules during the manufacturing process for quality control checks. Regular sampling is critical for verifying the uniformity, integrity, and compliance of capsules with regulatory and quality standards.

2. Scope

This SOP applies to all in-process capsules during manufacturing, from capsule filling to final product inspection. It covers sampling methods, frequency, and testing requirements to ensure that all capsules meet the required specifications.

3. Responsibilities

  • Manufacturing Team: Responsible for providing capsules for sampling according to the SOP and ensuring the proper handling and transfer of capsules to the QC team.
  • Quality Control (QC) Team: Responsible for performing the sampling and testing of in-process capsules and ensuring that samples are representative of the batch. QC also documents and reports the test results.
  • Quality Assurance (QA) Team: Ensures compliance with this SOP and verifies the results of quality checks to ensure regulatory requirements are met.
  • Capsule Manufacturing Supervisor: Ensures that the sampling process is carried out according to the SOP and that any deviations are addressed appropriately.

4. Accountability

The Capsule Manufacturing Supervisor is accountable for ensuring that the sampling process follows the SOP. The QA Manager is responsible for ensuring the results are reviewed and corrective actions are taken if necessary.

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5. Procedure

5.1 Sampling Methodology

Follow these steps to properly sample in-process capsules:

  1. Sampling Plan

    1. Develop a sampling plan based on the batch size and the critical quality attributes to be tested. The number of samples should be statistically significant and represent the entire batch.
    2. Ensure that the plan specifies the sampling method, frequency, and testing parameters (e.g., capsule weight, content uniformity, hardness, etc.).
  2. Sampling Procedure

    1. Sample capsules at different stages of the manufacturing process. Typical stages include after filling, after sealing, and after drying (for soft gelatin capsules).
    2. Use clean, dedicated sampling tools to collect the capsules. Ensure that the sampling method is designed to avoid contamination of the sample.
  3. Frequency of Sampling

    1. Samples should be taken at regular intervals throughout the production process. For large batches, samples should be collected from multiple points of the production line to ensure uniformity.
    2. Adjust the sampling frequency based on batch size, product risk, and historical data on process performance.

5.2 Handling and Transport of Samples

Ensure that in-process capsule samples are handled and transported properly:

  1. Labeling of Samples

    1. Label each sample container clearly with batch number, time of sampling, and the name of the operator. Record any observations about the sample, such as color, shape, or abnormalities.
  2. Transporting Samples

    1. Transport samples to the QC testing area promptly to minimize the risk of contamination or degradation.
    2. Ensure that samples are stored in appropriate conditions (e.g., temperature, humidity) while awaiting testing.
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5.3 Quality Control Testing

Perform the following tests on the in-process capsules:

  1. Weight Uniformity Test

    1. Weigh a sample of capsules from the batch and ensure that the average weight is within the specified range. Check individual capsule weights to ensure they meet the required specifications.
  2. Hardness and Friability Test

    1. Perform a hardness test on the capsules to ensure they can withstand mechanical stress during handling and packaging.
    2. Conduct a friability test to determine the capsule’s resistance to mechanical breakage during handling.
  3. Content Uniformity Test

    1. Test the capsule fill material for uniformity of the active ingredient content. Ensure that the fill weight and content are within the acceptable range.
  4. Visual Inspection

    1. Visually inspect the capsules for defects, such as cracks, discoloration, or improper sealing. Reject any capsules that do not meet visual quality standards.

5.4 Documentation and Record-Keeping

Ensure all sampling activities are documented properly:

  1. Sampling Records

    1. Document the details of the sampling procedure, including batch number, time, number of capsules sampled, and sampling location.
    2. Ensure that any deviations from the standard sampling plan are recorded and justified.
  2. Test Results

    1. Document the results of all quality control tests performed on the in-process capsule samples, including any out-of-specification (OOS) results.
  3. Deviation Reports

    1. If any deviations from the established specifications are observed, document them in a deviation report. Include corrective actions and preventive measures taken to address the issue.

5.5 Handling of Non-Conforming Capsules

If non-conforming capsules are detected during sampling, follow these steps:

  1. Segregation of Non-Conforming Capsules

    1. Immediately segregate any non-conforming capsules from the production line to prevent contamination of the remaining capsules.
  2. Root Cause Analysis

    1. Investigate the cause of non-conformance, whether it is due to material issues, equipment malfunction, or operator error.
    2. Perform corrective actions to address the root cause and prevent recurrence.
  3. Disposition of Non-Conforming Capsules

    1. Work with the QA team to determine whether the non-conforming capsules should be rejected, reworked, or disposed of according to regulatory guidelines.
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6. Abbreviations

  • SOP: Standard Operating Procedure
  • GMP: Good Manufacturing Practice
  • QC: Quality Control
  • QA: Quality Assurance
  • OOS: Out of Specification

7. Documents

  1. In-Process Capsule Sampling Record (Annexure-1)
  2. Quality Control Test Report (Annexure-2)
  3. Deviation Report (Annexure-3)

8. References

  • USP <1163> – Pharmaceutical Dosage Forms: Capsules
  • FDA Guidelines for Capsule Manufacturing
  • International Conference on Harmonization (ICH) Guidelines for Pharmaceutical Manufacturing

9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: In-Process Capsule Sampling Record

Batch ID Sampling Time Number of Capsules Sampled Operator Name Test Results
Batch 001 10:00 AM 10 John Doe Pass

Annexure-2: Quality Control Test Report

Test Type Result Specification Remarks
Weight Uniformity Pass 95-105 mg Meets standards

Annexure-3: Deviation Report

Deviation ID Description Corrective Action Action Taken By
DR-001 Capsule underweight Adjusted fill weight Manufacturing Supervisor

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 methodology Standardization QA Head
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