Standard Operating Procedure for Preparing Development Reports for Capsule Dosage Forms

Department	Capsule Manufacturing
SOP No.	SOP/CM/037/2025
Supersedes	SOP/CM/037/2022
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 preparing development reports for capsule dosage forms. These reports are critical for documenting the formulation, development process, and testing results, ensuring that the capsules meet all required specifications for efficacy, safety, and stability.

2. Scope

This SOP applies to the preparation of development reports for all capsule dosage forms under development. The report includes formulation details, testing data, and any necessary adjustments made during the development process.

3. Responsibilities

• Formulation Development Team: Responsible for providing all necessary information related to the formulation process, including ingredient details, process parameters, and modifications.
• Quality Control (QC) Team: Responsible for providing data on the quality of the capsule dosage forms, including stability, dissolution, and release testing results.
• Quality Assurance (QA) Team: Ensures that the development report adheres to regulatory requirements and company policies, and that all necessary documentation is properly reviewed and signed off.
• Manufacturing Team: Responsible for providing details on the production process, including any challenges faced during manufacturing and batch records.

4. Accountability

The Capsule Manufacturing Supervisor is accountable for ensuring that the development report is completed accurately and on time. The QA Manager is responsible for reviewing and approving the development report before it is finalized.

5. Procedure

5.1 Structure of the Development Report

The development report for capsule dosage forms should include the following sections:

1. Formulation Information
   1. Provide a detailed list of all ingredients, including APIs, excipients, and their respective quantities.
   2. Describe the purpose of each ingredient in the formulation (e.g., binder, filler, disintegrant, lubricant).
2. Manufacturing Process
   1. Document the step-by-step procedure for manufacturing the capsule dosage form, including any mixing, granulation, drying, and encapsulation steps.
   2. Include equipment specifications and settings used during the manufacturing process (e.g., mixer speed, granulation time, drying temperature).
3. Development Objectives
   1. State the primary objectives for the development of the capsule formulation (e.g., bioavailability, controlled release, taste masking).
   2. Include any specific challenges or objectives, such as optimizing capsule size or ensuring uniform content distribution.
4. Testing and Results
   1. Include all relevant testing data, such as stability, dissolution, release profiles, and microbiological testing.
   2. Ensure that all tests are conducted as per the protocol, and provide detailed results, including any deviations from the expected outcomes.
5. Formulation Adjustments
   1. Document any modifications made to the formulation based on test results or during the manufacturing process.
   2. Include reasons for adjustments, such as improving bioavailability, modifying release characteristics, or optimizing manufacturing efficiency.

5.2 Data Collection

Accurate data collection is critical for the development report:

1. Batch Records
   1. Ensure that batch records are completed for each batch of capsules produced during the development process.
   2. Document batch sizes, production times, and any deviations from standard operating procedures.
2. Testing Data
   1. Record all testing data, including particle size analysis, dissolution testing, moisture content, and other relevant parameters.
   2. Ensure that all testing is performed using validated methods and according to the approved protocols.
3. Observations
   1. Note any observations during the formulation or manufacturing process that may have impacted the development of the capsule dosage form, such as material behavior or equipment malfunction.

5.3 Report Writing

The report should be written in a clear and concise manner, including the following key points:

1. Introduction
   1. Provide an overview of the development project, including objectives, timeline, and scope of work.
2. Formulation Development
   1. Describe the formulation process, including ingredient selection, development of the formulation, and rationale behind each choice.
3. Process Development
   1. Document the step-by-step procedure for manufacturing the capsules, including the methods and equipment used during production.
4. Testing and Evaluation
   1. Provide a summary of all testing conducted on the capsules, including the results and any conclusions drawn from the data.
5. Conclusion and Recommendations
   1. Summarize the findings of the development process, including any necessary recommendations for future formulations or improvements in the manufacturing process.

5.4 Review and Approval

Before finalizing the development report, ensure that the following steps are completed:

1. Internal Review
   1. The report should be reviewed internally by the formulation development, quality control, and manufacturing teams for completeness and accuracy.
   2. Ensure that all data and results are clearly presented, and that the report aligns with the project objectives.
2. Quality Assurance Approval
   1. The final development report should be submitted to the QA team for review and approval to ensure that it complies with all regulatory requirements and internal standards.

5.5 Documentation and Record-Keeping

Ensure that all related documents and records are properly maintained:

1. Development Report Archive
   1. Once approved, the development report should be stored in an accessible location for future reference and audits.
2. Supporting Documents
   1. Maintain copies of all supporting documents, including batch records, test results, and observations, for traceability and compliance purposes.

6. Abbreviations

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

7. Documents

1. Development Report Template (Annexure-1)
2. Test Results Summary (Annexure-2)

8. References

• USP <711> – Dissolution Testing
• FDA Guidance for Industry: Stability Testing of Drug Products
• International Conference on Harmonization (ICH) Guidelines for Pharmaceutical Development

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Development Report Template

Section	Description
Formulation Information	Details of ingredients and their quantities.
Manufacturing Process	Step-by-step procedure used for capsule production.
Development Objectives	Specific goals set for the formulation and process.

Annexure-2: Test Results Summary

Test Type	Result	Specification	Remarks
Dissolution Test	Pass	Within USP limits	No deviations

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 report format	Standardization	QA Head