Standard Operating Procedure for Documentation Control 

Purpose

The purpose of this SOP is to establish guidelines for controlling and maintaining accurate records and documentation in the pharmaceutical warehouse to ensure compliance with regulatory requirements, traceability, and effective communication.

Scope

This SOP applies to all personnel involved in document creation, revision, approval, distribution, and archiving within the warehouse.

Responsibilities

• Document Control Officer: Overall responsibility for implementing documentation control procedures and ensuring compliance.
• Quality Assurance: Responsible for reviewing and approving controlled documents to ensure accuracy and compliance.
• Warehouse Managers: Responsible for ensuring that warehouse staff adhere to documentation control procedures.
• Operations Team: Responsible for following document control procedures and maintaining accurate records.

Procedure

1. Document Creation and Revision:
   • Assign responsibility for creating and revising documents to designated personnel.
   • Use standardized templates and formats for document creation to ensure consistency and clarity.
   • Establish a documented review and approval process for all new and revised documents.
2. Document Approval and Distribution:
   • Route documents for review and approval by designated personnel, such as subject matter experts and supervisors.
   • Maintain a record of document approvals and revisions, including dates and signatures of approvers.
   • Distribute approved documents to relevant personnel through controlled channels, such as document management systems or printed copies.
3. Document Control and Versioning:
   • Establish a centralized document repository or database to manage controlled documents.
   • Assign unique document numbers or identifiers to track document versions and revisions.
   • Implement document version control procedures to ensure that only the latest approved version is available for use.
4. Document Retrieval and Archiving:
   • Ensure that controlled documents are readily accessible to authorized personnel as needed.
   • Establish procedures for document retrieval, including search capabilities and access controls.
   • Regularly review and update document archives to ensure that obsolete or superseded documents are properly archived or disposed of.

Abbreviations

• SOP: Standard Operating Procedure

Documents

• Document Control Procedure Manual
• Document Review and Approval Forms
• Document Distribution Records
• Document Version Control Log
• Document Retrieval and Archiving Guidelines

SOP Version

Version 1.0