Standard Operating Procedure for Documentation Control

1) Purpose

This SOP outlines the procedures for the creation, review, approval, distribution, and maintenance of documents to ensure consistency, accuracy, accessibility, and compliance with regulatory requirements.

2) Scope

This SOP applies to all departments and personnel involved in creating, reviewing, approving, distributing, and maintaining documents within the company, including quality assurance, regulatory affairs, manufacturing, and research and development.

3) Responsibilities

The Quality Assurance (QA) department is responsible for overseeing the document control process. All personnel are responsible for adhering to document control procedures and ensuring that documents are accurate, current, and accessible.

4) Procedure

4.1 Document Creation and Review

1. Create documents using approved templates and formats.
2. Assign document numbers or codes for identification purposes.
3. Ensure documents are reviewed by designated personnel for accuracy, completeness, and compliance with established procedures.

4.2 Document Approval

1. Obtain approval for documents from authorized personnel, such as department heads or designated approvers.
2. Document approvals and ensure signatures or electronic approvals are obtained as per company procedures.

4.3 Document Distribution

1. Distribute approved documents to relevant departments or individuals as per distribution lists.
2. Ensure controlled distribution to prevent unauthorized use of obsolete documents.

4.4 Document Maintenance

1. Maintain a master list or document register to track document status, including revision history, current versions, and location of documents.
2. Regularly review and update documents as necessary to ensure accuracy and relevance.

4.5 Document Retrieval and Control of Obsolete Documents

1. Establish procedures for document retrieval to ensure access to current versions.
2. Identify and control obsolete documents to prevent unintended use.

4.6 Document Archiving and Record Retention

1. Archive documents in accordance with document retention policies and regulatory requirements.
2. Ensure documents are stored securely and are readily retrievable for audits and inspections.

5) Abbreviations, if any

QA: Quality Assurance
SOP: Standard Operating Procedure

6) Documents, if any

Document Templates, Document Register, Distribution Lists, Document Retention Policy

7) Reference, if any

Regulatory guidelines such as FDA, EMA, ICH Q7 (Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients), and ISO 9001 (Quality Management Systems)

8) SOP Version

Version 1.0