Capsule: SOP for Capsule Size Customization for Clinical Trials – V 2.0

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Capsule: SOP for Capsule Size Customization for Clinical Trials – V 2.0

Standard Operating Procedure for Capsule Size Customization for Clinical Trials

Department Capsule Manufacturing
SOP No. SOP/CM/099/2025
Supersedes SOP/CM/099/2022
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 customizing capsule size for clinical trials. Capsule size customization is crucial in clinical trials to ensure that the dosage is appropriate for trial participants, while also complying with regulatory and quality requirements.

2. Scope

This SOP applies to the process of customizing capsule size for clinical trials within the capsule manufacturing department. It covers the steps from the selection of the appropriate capsule size to the manufacturing and inspection of capsules to ensure they meet the specific requirements for clinical trial formulations.

3. Responsibilities

  • Production Operators: Responsible for loading and customizing the capsule sizes according to the clinical trial specifications and ensuring the process runs smoothly.
  • Quality Control (QC) Team: Responsible for inspecting and verifying that the capsules meet the required specifications for size, fill volume, and integrity.
  • Quality Assurance (QA) Team: Ensures that the SOP is followed and that the final product is compliant with clinical trial requirements and regulatory standards.
  • Production Supervisor: Oversees the capsule size customization process and ensures that all steps are completed according to the SOP. The supervisor is also responsible for addressing any deviations in the process.

4. Accountability

The Capsule Manufacturing Supervisor is accountable for ensuring that capsule sizes are customized according to the clinical trial requirements and that the process is compliant with all regulatory standards. The QA Manager is responsible for approving the final product and ensuring compliance with SOP and regulatory standards.

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5. Procedure

5.1 Selecting the Appropriate Capsule Size

The selection of the appropriate capsule size is based on clinical trial requirements and the formulation of the active ingredient. Follow these steps to select the appropriate capsule size:

  1. Review Clinical Trial Requirements

    1. Determine the dosage requirements for the clinical trial based on the active pharmaceutical ingredient (API) and excipients used in the formulation.
    2. Consult the trial specifications to determine the amount of API and excipient required per capsule.
  2. Select Capsule Size

    1. Based on the required dosage, select the capsule size that can accommodate the correct fill volume. Consider factors such as capsule size, volume, and patient tolerance.
    2. Refer to a standard capsule size chart or consult with the formulation team to ensure the selected size meets the clinical trial requirements.

5.2 Customizing Capsule Size

Once the appropriate capsule size is selected, the following steps should be followed to customize the capsule size for clinical trials:

  1. Adjust Capsule Filling Equipment

    1. Ensure the filling machine is properly set up to accommodate the selected capsule size, including adjusting the fill weight and volume settings.
    2. Ensure that the capsule filling machine can handle the specific formulation (e.g., powder, pellets, liquid) being used in the clinical trial.
  2. Prepare the Formulation

    1. Prepare the API and excipient formulation according to the clinical trial’s specifications, ensuring that the fill weight matches the required dosage for the selected capsule size.
    2. Ensure that the formulation is homogeneous and free from clumps or other defects that could affect capsule size and weight.
  3. Encapsulate the Formulation

    1. Load the formulation into the capsule filling machine and start the encapsulation process, ensuring that each capsule is filled to the required weight and size.
    2. Monitor the process to ensure that capsules are being filled correctly and that the size remains consistent throughout production.
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5.3 Quality Control and Inspection

Once the capsules have been filled, the following quality control steps should be performed:

  1. Verify Capsule Size

    1. Perform a visual inspection of the capsules to ensure that they conform to the selected size and that there are no deformities or irregularities.
    2. Measure a sample of capsules from each batch to ensure that they are within the size tolerances specified in the clinical trial requirements.
  2. Check Fill Weight

    1. Check the weight of a random sample of capsules to verify that the fill weight is within the specified limits.
    2. Ensure that the capsules are consistent in weight and meet the required specifications for the clinical trial.
  3. Reject Non-Conforming Capsules

    1. Any capsules that do not meet the size or weight specifications should be rejected. These capsules should be segregated and disposed of according to company waste disposal procedures.
    2. Document all deviations or rejections in the Reject Log (Annexure-1) and investigate the cause of non-conformance.

5.4 Documentation and Reporting

Ensure that all steps in the capsule size customization process are documented:

  1. Maintain Batch Records

    1. Document all details related to the clinical trial capsule size, including capsule size selection, formulation preparation, machine settings, and capsule inspection results in the Batch Production Record (BPR) (Annexure-2).
  2. Record Deviations

    1. Document any deviations from the SOP, including reasons for deviations and corrective actions taken, in the Deviation Log (Annexure-3).
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5.5 Final Approval for Clinical Trial Capsules

Once the capsules meet all required specifications, follow these steps:

  1. QA Review

    1. The QA team should review the batch records and quality control results to ensure that the capsules meet the clinical trial specifications.
  2. Approval for Packaging

    1. If the capsules meet all required specifications, the batch is approved for packaging and labeling, and can be used in the clinical trial.

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-2)
  2. Deviation Log (Annexure-3)
  3. Reject Log (Annexure-1)

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: Reject Log

Batch ID Reason for Rejection Number of Rejected Capsules Corrective Action
Batch 001 Capsules out of size specifications 50 Recalibrated filling machine settings

Annexure-2: Batch Production Record (BPR)

Batch ID Capsule Size Fill Weight Capsule Quality Check Rejected Capsules
Batch 001 Size 0 500 mg Pass 0

Annexure-3: Deviation Log

Deviation ID DescriptionCorrective Action Operator Name Approval Status
DEV-001 Capsules outside acceptable size tolerance Recalibrated capsule filling machine and adjusted machine speed 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 process and documentation for capsule size customization Standardization QA Head
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