SOP Guide for Pharma

Capsule: SOP for Designing Clinical Trial Batches of Capsules – V 2.0

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Capsule: SOP for Designing Clinical Trial Batches of Capsules – V 2.0

Standard Operating Procedure for Designing Clinical Trial Batches of Capsules

Department Capsule Manufacturing
SOP No. SOP/CM/026/2025
Supersedes SOP/CM/026/2022
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 the procedure for designing clinical trial batches of capsules, ensuring the development of an appropriate and scalable formulation for clinical testing while maintaining regulatory compliance and safety standards.

2. Scope

This SOP applies to the preparation and manufacturing of clinical trial batches of capsules, from the formulation development phase to the final batch release, ensuring compliance with regulatory requirements and good manufacturing practices (GMP).

3. Responsibilities

4. Accountability

The Formulation Development Supervisor is accountable for ensuring that the clinical trial batches are designed and developed according to this SOP. The QA Manager is responsible for ensuring that all batch production activities comply with quality and regulatory standards.

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5. Procedure

5.1 Defining Clinical Trial Requirements

Ensure that the clinical trial requirements are clearly defined before beginning the formulation development:

  1. Clinical Trial Objectives
    1. Determine the specific goals of the clinical trial, such as bioavailability, safety, efficacy, or dose-ranging studies.
    2. Ensure the formulation meets the requirements for the clinical trial endpoints, considering the type of capsule (e.g., immediate release, controlled release, or enteric coated).
  2. Regulatory Requirements
    1. Review the applicable regulatory guidelines for clinical trials, such as ICH E6 or local regulatory authorities (e.g., US FDA, EMA), to ensure the clinical trial batch meets all regulatory and safety standards.

5.2 Selecting Ingredients for Clinical Trial Batches

Choose the appropriate ingredients based on the clinical trial objectives:

  1. API Selection
    1. Select the API based on its intended therapeutic effect, solubility, stability, and bioavailability profile required for the clinical trial.
    2. Ensure that the API is available in the required quantity and form for clinical trial use.
  2. Excipients Selection
    1. Select excipients based on their ability to provide appropriate release profiles, stability, and compatibility with the API.
    2. Ensure that excipients meet pharmacopoeial standards and have been proven to be safe for use in clinical trials.

5.3 Formulation Development for Clinical Trial Batches

Develop the formulation based on the selected API and excipients, ensuring it meets the clinical trial requirements:

  1. Formulation Optimization
    1. Optimize the formulation for the desired release characteristics (e.g., immediate, sustained, or controlled release).
    2. Conduct stability studies on the formulation to ensure it maintains its efficacy and safety during the trial period.
  2. Capsule Shell Selection
    1. Choose the appropriate capsule shell material based on the formulation type (e.g., gelatin or HPMC for vegetarian capsules).
    2. Ensure that the capsule shell is compatible with the formulation and does not interfere with API release.
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5.4 Manufacturing of Clinical Trial Batches

Prepare the clinical trial batches under controlled conditions, adhering to GMP standards:

  1. Batch Production
    1. Prepare the batch following the developed formulation, ensuring proper mixing and blending of ingredients.
    2. Use the appropriate encapsulation process (e.g., soft gel encapsulation or hard gelatin capsule filling) to produce the clinical trial batches.
  2. Equipment Calibration
    1. Ensure that all equipment used in the manufacturing process is calibrated and functioning correctly before batch production.

5.5 Testing and Evaluation of Clinical Trial Batches

Conduct tests to ensure that the clinical trial batches meet the required specifications:

  1. Quality Control Testing
    1. Test the clinical trial batches for uniformity, content uniformity, dissolution rate, and API release profile.
    2. Conduct stability testing to ensure that the batch will maintain its integrity throughout the clinical trial.
  2. Microbial Testing
    1. Perform microbial testing to ensure the clinical trial batches are free from harmful microorganisms that could affect the safety of participants.

5.6 Documentation of Clinical Trial Batches

Ensure proper documentation for all activities related to the clinical trial batches:

  1. Batch Production Records
    1. Document the batch production process, including the formulation, equipment used, and process parameters for each batch.
  2. Testing and Release Records
    1. Document the results of all quality control and stability tests, including dissolution, content uniformity, and microbial testing.
    2. Ensure that all results are reviewed and approved by the QA team before batch release.
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5.7 Regulatory Submission and Approval

Prepare the necessary documentation for regulatory submission:

  1. Regulatory Filing
    1. Prepare the regulatory submission for the clinical trial batch, including the batch records, testing results, and stability data.
    2. Ensure that all documentation is in compliance with regulatory guidelines and is submitted to the appropriate authorities for approval.

6. Abbreviations

7. Documents

  1. Clinical Trial Batch Report (Annexure-1)
  2. Batch Production Record (Annexure-2)
  3. Stability Testing Report (Annexure-3)

8. References

9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Clinical Trial Batch Report

Date Batch Number Formulation Testing Results Approval
03/02/2025 CTB-123 Capsule A Pass Approved by QA

Annexure-2: Batch Production Record

Date Batch Number Equipment Used Production Parameters
03/02/2025 CTB-123 Encapsulation Machine 1 Temperature: 40°C, Speed: 50 rpm

Annexure-3: Stability Testing Report

Date Test Type Result Action Taken
04/02/2025 Accelerated Stability No degradation Proceed with clinical trials

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 clinical trial batch process Standardization and clarity QA Head
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