Document Control – Standard Operating Procedure

1) Purpose

To establish guidelines for controlling the creation, review, approval, distribution, and maintenance of documents within the pharmaceutical manufacturing department.

2) Scope

This SOP applies to all documents, including procedures, specifications, forms, and records, that are critical to the quality and compliance of pharmaceutical products.

3) Responsibilities

Quality Assurance Team: Responsible for overseeing document control processes.
Department Heads: Responsible for document creation, review, and approval.

4) Procedure

4.1) Document Creation:
4.1.1) Define document requirements and format based on regulatory standards and internal guidelines.
4.1.2) Draft documents using approved templates and ensure clarity, accuracy, and completeness.

4.2) Document Review and Approval:
4.2.1) Review documents for technical accuracy, compliance, and alignment with procedures.
4.2.2) Obtain approval from designated personnel before distribution and use.

4.3) Document Distribution:
4.3.1) Distribute approved documents to relevant personnel or departments.
4.3.2) Ensure controlled distribution to prevent unauthorized use or outdated versions.

4.4) Document Maintenance:
4.4.1) Maintain documents in a controlled environment to prevent loss, damage, or unauthorized access.
4.4.2) Archive obsolete documents and ensure availability of current versions.

4.5) Document Retrieval and Accessibility:
4.5.1) Establish procedures for document retrieval and access by authorized personnel.
4.5.2) Provide training on document control procedures and ensure awareness among staff.

4.6) Document Change Control:
4.6.1) Implement a change control process to manage revisions, amendments, and updates to documents.
4.6.2) Review and approve document changes according to established procedures.

5) Abbreviations, if any

N/A

6) Documents, if any

• Document Templates
• Document Change Request Forms
• Document Distribution Logs
• Obsolete Document Archive

7) Reference, if any

Regulatory Guidelines: FDA CFR Part 211.100, ICH Q7
Industry Standards: ISO 9001:2015

8) SOP Version

Version 1.0