Standard Operating Procedure for Regulatory Submission for Gels

1) Purpose

The purpose of this SOP is to establish procedures for the preparation, compilation, and submission of regulatory documents related to gels to regulatory authorities, ensuring compliance with applicable laws, regulations, and guidelines.

2) Scope

This SOP applies to all personnel involved in the pharmaceutical manufacturing facility’s Regulatory Affairs department, including Regulatory Affairs Managers, Quality Assurance (QA), Formulation Scientists, and other relevant personnel responsible for regulatory submissions.

3) Responsibilities

Regulatory Affairs Managers: Coordinate and oversee regulatory submission activities, ensuring compliance with timelines and regulatory requirements.
Quality Assurance (QA): Verify accuracy and completeness of regulatory documents and provide support during regulatory inspections.
Formulation Scientists: Provide technical data and information required for regulatory submissions.
Legal Counsel: Provide legal guidance on regulatory requirements and ensure compliance with laws and regulations.
Clinical Research: Provide clinical trial data and reports necessary for regulatory submissions.

4) Procedure

4.1 Document Preparation
4.1.1 Identify regulatory requirements and compile necessary documentation, including drug master files (DMFs), quality data, and clinical trial reports.
4.1.2 Review and ensure accuracy of all regulatory documents, including labeling, product information, and safety data sheets.

4.2 Submission Planning
4.2.1 Develop a Regulatory Submission Plan outlining submission timelines, milestones, and responsibilities.
4.2.2 Coordinate with cross-functional teams to gather required information and data for timely submission.

4.3 Submission Compilation
4.3.1 Compile all required documents in accordance with regulatory guidelines and submission formats (e.g., Common Technical Document (CTD)).
4.3.2 Ensure translations of documents into local languages where required for submission to international regulatory agencies.

4.4 Submission to Regulatory Authorities
4.4.1 Submit regulatory documents electronically or in hard copy format as per regulatory requirements.
4.4.2 Monitor submission status and address any queries or requests for additional information from regulatory authorities promptly.

4.5 Post-Submission Activities
4.5.1 Track and record submission timelines, approval statuses, and any regulatory commitments.
4.5.2 Prepare for and support regulatory inspections and audits related to the submitted applications.

4.6 Documentation and Archiving
4.6.1 Maintain comprehensive documentation of all regulatory submissions, correspondence with regulatory authorities, and approvals.
4.6.2 Archive regulatory submission documents in accordance with company and regulatory requirements.

5) Abbreviations, if any

SOP: Standard Operating Procedure
DMF: Drug Master File
CTD: Common Technical Document

6) Documents, if any

– Regulatory Submission Plan
– Compiled Regulatory Documents (e.g., CTD sections)
– Correspondence with Regulatory Authorities
– Approval Notifications and Commitments

7) Reference, if any

– FDA Guidance for Industry: Providing Regulatory Submissions in Electronic Format — Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications
– ICH Guidelines for Regulatory Affairs
– Company-specific regulatory submission procedures and guidelines

8) SOP Version

Version 1.0