Standard Operating Procedure for Preparing Technical Dossiers for Capsules

Department	Capsule Manufacturing
SOP No.	SOP/CM/047/2025
Supersedes	SOP/CM/047/2022
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 define the procedures for preparing technical dossiers for capsules. These dossiers are essential for regulatory submissions, ensuring that capsules meet the necessary safety, efficacy, and quality standards as required by authorities such as the FDA, EMA, and other global regulatory bodies.

2. Scope

This SOP applies to the preparation of technical dossiers for capsule formulations in pharmaceutical manufacturing. It covers all required documents, data, and test results that need to be compiled for the regulatory approval process.

3. Responsibilities

• Formulation Development Team: Responsible for providing all formulation-related data, including stability studies, excipient compatibility, and product development history.
• Regulatory Affairs Team: Responsible for compiling the dossier, ensuring all required documents are included and up to date, and submitting the dossier to regulatory bodies.
• Manufacturing Team: Responsible for providing production process documentation, including batch records, equipment validation, and process controls.
• Quality Control (QC) Team: Responsible for providing testing data, including analytical testing, quality control procedures, and testing results for the capsules.
• Quality Assurance (QA) Team: Ensures that the dossier complies with Good Manufacturing Practices (GMP), regulatory guidelines, and internal quality standards.

4. Accountability

The Capsule Manufacturing Supervisor is accountable for ensuring that the technical dossier is prepared in accordance with this SOP. The Regulatory Affairs Manager is responsible for reviewing the dossier and ensuring that it complies with all relevant regulatory requirements.

5. Procedure

5.1 Document Collection

The following documents should be collected and reviewed to form the technical dossier:

1. Product Information
   1. Provide a detailed description of the capsule, including its composition (API, excipients), dosage form, strength, and intended use.
2. Manufacturing Process
   1. Include detailed descriptions of the capsule manufacturing process, including formulation, granulation, encapsulation, and coating processes.
   2. Provide process flow diagrams and detailed batch records for each manufacturing step.
3. Stability Data
   1. Include data from stability studies conducted on the capsules, covering accelerated and long-term stability testing results, and any observed changes in product performance over time.
4. Analytical Test Data
   1. Provide results of all analytical tests, including dissolution profiles, content uniformity, potency testing, and any other relevant tests conducted during product development.
5. Excipient Information
   1. Provide details of all excipients used in the formulation, including their chemical composition, source, and rationale for selection. Ensure that excipient compatibility data is included.

5.2 Regulatory Requirements

Ensure that the technical dossier complies with the requirements of the relevant regulatory authority:

1. International Guidelines
   1. Ensure that the dossier meets the requirements of international regulatory bodies, such as the FDA (USA), EMA (EU), and ICH guidelines, ensuring that all necessary documents are included.
2. Country-Specific Requirements
   1. In addition to international guidelines, ensure compliance with country-specific regulations regarding pharmaceutical dossiers for the intended market.
3. Submission Format
   1. Follow the submission format required by the regulatory body, which may include electronic submissions (eCTD) or paper-based formats.

5.3 Compilation of the Technical Dossier

Once all required data is collected, proceed to compile the dossier:

1. Document Organization
   1. Organize all collected documents into sections, such as product information, manufacturing process, stability data, and test results. Ensure that each section is clearly labeled and easy to navigate.
2. Cross-Referencing
   1. Ensure that all relevant documents are cross-referenced appropriately within the dossier. For example, analytical test results should reference the specific product batch and manufacturing process.
3. Formatting
   1. Ensure the technical dossier is formatted according to the regulatory authority’s guidelines. Use appropriate headings, numbering, and pagination for ease of reading.
4. Review and Approval
   1. Before submission, the technical dossier should undergo a thorough internal review by all relevant departments (e.g., formulation development, QC, regulatory affairs) to ensure completeness and compliance with regulatory requirements.

5.4 Submission of the Dossier

Once the technical dossier is complete, submit it to the regulatory authority:

1. Electronic Submission
   1. If the submission is electronic, prepare the dossier in the required format (eCTD or other regulatory submission systems) and submit it via the appropriate regulatory submission portal.
2. Paper Submission
   1. If paper submission is required, ensure that the dossier is printed and bound according to regulatory specifications and sent to the appropriate regulatory authority.

5.5 Post-Submission Activities

After submission, monitor the progress of the submission and respond to any queries raised by the regulatory body:

1. Regulatory Review
   1. Monitor the status of the submission and address any queries or requests for additional information raised by the regulatory authorities during the review process.
2. Approval and Marketing Authorization
   1. Once the regulatory authority grants marketing authorization, update all internal records to reflect the approved formulation and include the approval documentation in the dossier.

5.6 Documentation and Record-Keeping

Ensure that all aspects of the dossier preparation and submission process are documented:

1. Dossier Compilation Records
   1. Maintain records of all documents included in the technical dossier, as well as the review and approval process.
2. Regulatory Submission Records
   1. Document the submission date, method of submission, and any communication with regulatory authorities related to the dossier submission.
3. Approval Documentation
   1. Keep a copy of the marketing authorization or approval letter from the regulatory authority in the company’s records.

6. Abbreviations

• SOP: Standard Operating Procedure
• QA: Quality Assurance
• QC: Quality Control
• API: Active Pharmaceutical Ingredient
• GMP: Good Manufacturing Practice
• eCTD: Electronic Common Technical Document

7. Documents

1. Technical Dossier Compilation Record (Annexure-1)
2. Regulatory Submission Record (Annexure-2)
3. Approval Documentation (Annexure-3)

8. References

• FDA Guidance for Industry: Preparing Drug Applications
• International Conference on Harmonization (ICH) Guidelines for Technical Dossier Preparation
• EMA Guidelines for Submission of Pharmaceutical Applications

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Technical Dossier Compilation Record

Document Type	Status	Reviewed By
Formulation Data	Completed	Regulatory Affairs
Stability Data	Completed	QC Department

Annexure-2: Regulatory Submission Record

Submission Method	Submission Date	Regulatory Authority
eCTD	01/02/2025	FDA

Annexure-3: Approval Documentation

Approval Date	Approval Authority	Approval Number
15/03/2025	FDA	FDA-123456

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 submission procedures	Standardization	QA Head