Standard Operating Procedure for Retention and Archival of Documents in Vaginal Dosage Form Manufacturing
1) Purpose
The purpose of this SOP is to establish procedures for the retention, storage, and archival of documents related to the manufacturing of vaginal dosage forms to ensure compliance with regulatory requirements and facilitate document retrieval as needed.
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 document retention and archival procedures. Department heads and personnel are responsible for ensuring documents are stored and archived appropriately.
4) Procedure
4.1 Document Retention Period
- Determine retention periods for different types of documents based on regulatory requirements and internal policies.
- Maintain a master list of document types and their respective retention periods.
4.2 Storage Conditions
- Store documents in secure and climate-controlled environments to prevent damage or deterioration.
- Ensure documents are protected from fire, water, pests, and other potential hazards.
4.3 Archival Procedures
- Identify documents eligible for archival based on their retention periods.
- Prepare documents for archival storage, including labeling and packaging.
- Transfer documents to designated archival storage areas.
4.4 Document Retrieval
- Establish procedures for retrieving archived documents as needed.
- Maintain an index or catalog of archived documents for easy retrieval.
4.5 Document Destruction
- Implement procedures for the destruction of documents that have reached the end of their retention periods.
- Ensure destruction methods are compliant with environmental regulations and data protection policies.
5) Abbreviations, if any
QA: Quality Assurance; SOP: Standard Operating Procedure; GMP: Good Manufacturing Practice
6) Documents, if any
Document retention schedule, Archival storage procedure, Destruction certificate template
7) Reference, if any
ICH Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients, WHO Technical Report Series No. 992, Annex 5: Guidelines for Good Manufacturing Practices for Pharmaceutical Products: Document Handling and Record Keeping
8) SOP Version
Version 1.0
