Regulatory Filing Process in Formulation Development

1) Purpose

The purpose of this SOP is to outline the procedure for filing regulatory submissions during the formulation development process, ensuring compliance with regulatory requirements and facilitating the approval of products for market entry.

2) Scope

This SOP applies to all formulation development projects within the organization, covering the filing of regulatory submissions for new formulations, changes, or renewals.

3) Responsibilities

The responsibilities for this SOP include:
Regulatory Affairs: Leading and coordinating the regulatory filing process, ensuring submissions are complete, accurate, and submitted on time.
Project Manager: Providing project-specific information and supporting regulatory affairs in preparing and filing submissions.
Quality Assurance: Reviewing and approving submission documents to ensure compliance with regulatory standards.
Formulation Development Team: Providing technical data, reports, and other necessary information for regulatory filings.

4) Procedure

4.1 Preparing for Filing

1. Review the regulatory strategy and requirements outlined in the regulatory submission plan.
2. Ensure all required documentation, technical data, and reports are compiled and finalized.
3. Verify that all documents meet regulatory guidelines and internal quality standards.

4.2 Submission Preparation

1. Organize submission documents according to regulatory agency requirements (e.g., format, sections).
2. Prepare necessary forms, declarations, and supporting documentation as per regulatory guidelines.
3. Ensure accuracy, completeness, and alignment with the regulatory submission plan.

4.3 Filing Submission

1. Submit the prepared regulatory filing package to the appropriate regulatory authority within the designated timeline.
2. Track submission status and promptly respond to any queries or requests for additional information from regulatory agencies.
3. Collaborate with regulatory agencies during the review process and provide clarifications or additional data as needed.

4.4 Review and Approval

1. Monitor the progress of regulatory review activities and communicate updates to stakeholders as necessary.
2. Address any deficiencies or concerns raised during the review process and implement corrective actions promptly.
3. Obtain regulatory approval for the filing based on compliance with regulatory requirements and standards.

4.5 Post-Approval Activities

1. Archive a copy of the approved regulatory filing package and related correspondence for future reference and regulatory inspections.
2. Maintain records of all regulatory filings, approvals, and amendments in accordance with company policies and regulatory requirements.

5) Abbreviations, if any

SOP: Standard Operating Procedure

6) Documents, if any

Regulatory Submission Plan
Submission Documents
Correspondence with Regulatory Agencies
Approved Filing Package

7) Reference, if any

– ICH M4: Common Technical Document for the Registration of Pharmaceuticals for Human Use
– FDA Guidance for Industry: Providing Regulatory Submissions in Electronic Format

8) SOP Version

Version 1.0