Capsule: SOP for Preparing Filled Capsules for Packing – V 2.0

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Capsule: SOP for Preparing Filled Capsules for Packing – V 2.0

Standard Operating Procedure for Preparing Filled Capsules for Packing

Department Capsule Manufacturing
SOP No. SOP/CM/091/2025
Supersedes SOP/CM/091/2022
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 preparing filled capsules for the packing process. Proper preparation ensures that the capsules are correctly handled, verified, and stored in compliance with GMP guidelines before they are packed for distribution.

2. Scope

This SOP applies to all filled capsules that are ready for packing. It covers the procedures for checking the quality, verifying the fill, sorting, and preparing capsules for packaging.

3. Responsibilities

  • Production Operators: Responsible for sorting, verifying, and ensuring the quality of the filled capsules before they are sent to the packing area.
  • Quality Control (QC) Team: Responsible for performing final checks and inspections of the filled capsules, ensuring they meet the required specifications before packing.
  • Quality Assurance (QA) Team: Ensures compliance with GMP standards and the SOP during the preparation process, verifying that the filled capsules are prepared according to company and regulatory requirements.
  • Production Supervisor: Oversees the preparation process, ensures adherence to SOPs, and ensures that capsules are correctly prepared for packing.

4. Accountability

The Capsule Manufacturing Supervisor is accountable for ensuring that all filled capsules are properly prepared for packing according to the SOP. The QA Manager is responsible for reviewing and approving the preparation process and ensuring it meets regulatory standards.

5. Procedure

5.1 Preparing Capsules for Packing

Follow these steps to prepare filled capsules for packing:

  1. Check for Quality and Compliance

    1. Ensure that the filled capsules have passed all in-process inspections and quality checks, such as weight uniformity and capsule fill verification.
    2. Verify that the capsules meet the required specifications for appearance, weight, and integrity.
    3. Check that the batch number and lot number are correctly labeled and recorded in the Batch Production Record (BPR).
  2. Sorting the Capsules

    1. Sort the capsules according to size, shape, and appearance. Remove any damaged, deformed, or discolored capsules.
    2. Ensure that capsules are free from any contamination or foreign particles.
  3. Ensure Capsule Fill Consistency

    1. Check the consistency of the capsule fill to ensure that each capsule has the correct amount of product inside.
    2. Use a sample of capsules to verify fill weight using a calibrated balance or automated filling verification system.
  4. Final Inspection

    1. Perform a final inspection of the filled capsules for uniformity, labeling, and cleanliness. Any capsules that do not meet the specified standards should be removed from the batch.
    2. Inspect capsules for proper sealing, especially for soft gelatin capsules, ensuring they are properly closed and free from any leaks.
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5.2 Preparing Capsules for Packaging

Once the filled capsules have passed the quality checks, they are ready for packaging:

  1. Verify Packaging Materials

    1. Ensure that the correct packaging materials, including bottles, blister packs, and labels, are available and ready for use.
    2. Check that the packaging materials are clean, undamaged, and appropriate for the type of capsules being packed.
  2. Package Capsules

    1. Carefully transfer the sorted and inspected capsules to the packaging line for bottling, blistering, or other packaging processes.
    2. Ensure that the capsules are handled gently to prevent damage or contamination.
  3. Labeling and Documentation

    1. Ensure that all packaging is labeled with the correct lot number, product name, and other required information as per regulatory guidelines.
    2. Record the quantity of capsules packed, the packaging materials used, and any relevant batch information in the Batch Production Record (BPR).
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5.3 Verifying the Prepared Capsules

Once the capsules have been prepared for packing, the following verification steps should be conducted:

  1. Quality Control Inspection

    1. The QC team should perform a final inspection to confirm that all prepared capsules meet the required quality standards and are ready for packing.
    2. QC should verify that all relevant documentation, including the BPR, is completed accurately.
  2. Sign-Off on Prepared Capsules

    1. Once the QC team has completed their inspection and verified that all capsules are prepared properly, the batch can be signed off for packing.
    2. The QA team should review the process and confirm that it complies with the GMP standards before approving the batch for packaging.

5.4 Handling Deviations in Capsule Preparation

If any deviations are observed during the preparation process, the following actions should be taken:

  1. Document Deviations

    1. Any deviations from the expected capsule quality, size, or fill must be documented in the deviation log.
    2. Include the cause of the deviation, corrective actions taken, and any impact on the batch in the deviation report.
  2. Investigate the Cause

    1. Investigate the root cause of the deviation, whether it is related to equipment, material quality, or operator error.
  3. Implement Corrective Actions

    1. Implement corrective actions to address the cause of the deviation, such as adjusting equipment settings or re-training operators.
    2. Perform additional checks on the affected batch to ensure it is brought up to standard before proceeding with packaging.

5.5 Final Approval and Documentation

After the preparation process is completed and verified, the following steps should be taken:

  1. Final QA Review

    1. The QA team should review the entire preparation and inspection process, ensuring that all required steps have been completed.
    2. Ensure that the final product meets all quality standards and that all deviations have been addressed and documented.
  2. Sign-Off and Approval for Packing

    1. Once the final review is complete, the QA team should approve the batch for packaging.
    2. The capsules can then be moved to the packaging area for the next steps in the manufacturing process.
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6. Abbreviations

  • SOP: Standard Operating Procedure
  • GMP: Good Manufacturing Practice
  • QC: Quality Control
  • QA: Quality Assurance
  • BPR: Batch Production Record

7. Documents

  1. Batch Production Record (BPR) (Annexure-1)
  2. Deviation Log (Annexure-2)
  3. Capsule Packaging Log (Annexure-3)

8. References

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

Batch ID Capsules Prepared Lot Number Operator Name Approval Status
Batch 001 10,000 2025-001-01 John Doe Approved

Annexure-2: Deviation Log

Deviation ID Description Corrective Action Taken Operator Name Approval Status
DEV-001 Incorrect fill weight detected Adjusted machine settings and recalibrated Jane Smith Approved

Annexure-3: Capsule Packaging Log

Batch ID Packaging Date Operator Name Quantity Packed Approval Status
Batch 001 02/02/2025 John Doe 10,000 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 Revised packaging and final inspection process Standardization QA Head
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