Standard Operating Procedure for Document Control in Vaginal Dosage Form Manufacturing

1) Purpose

The purpose of this SOP is to establish a system for the control, issuance, revision, and archival of documents related to the manufacturing of vaginal dosage forms to ensure compliance with regulatory requirements and consistency in document management.

2) Scope

This SOP applies to all departments involved in the creation, review, approval, distribution, and maintenance of documents at [Company Name] related to vaginal dosage form manufacturing.

3) Responsibilities

Quality Assurance (QA) is responsible for implementing and maintaining the document control system. Department heads and personnel are responsible for following document control procedures and ensuring adherence to document requirements.

4) Procedure

4.1 Document Creation and Review

1. Create new documents or revise existing documents as required.
2. Assign document number, title, and version control.
3. Review documents for accuracy, completeness, and compliance.

4.2 Document Approval and Distribution

1. Submit documents for approval according to the document approval matrix.
2. Distribute approved documents to relevant departments or personnel.

4.3 Document Change Control

1. Initiate change requests for document revisions.
2. Assess the impact of proposed changes and obtain necessary approvals.
3. Implement approved changes and update documents accordingly.

4.4 Document Retrieval and Obsolete Document Control

1. Maintain a master list of controlled documents and their locations.
2. Retire and archive obsolete documents in accordance with retention policies.

4.5 Document Training and Awareness

1. Provide training on document control procedures to relevant personnel.
2. Ensure awareness of document control requirements and responsibilities.

5) Abbreviations, if any

QA: Quality Assurance; SOP: Standard Operating Procedure; GMP: Good Manufacturing Practice

6) Documents, if any

Document control procedure template, Document change request form, Document approval matrix

7) Reference, if any

ICH Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients, WHO Technical Report Series No. 992, Annex 4: Guidelines for Good Manufacturing Practices for Pharmaceutical Products: Main Principles

8) SOP Version

Version 1.0