Standard Operating Procedure for Document Control and Management
1) Purpose
The purpose of this Standard Operating Procedure (SOP) is to establish a framework for the creation, review, approval, distribution, and maintenance of documents within the pharmaceutical manufacturing facility to ensure accuracy, traceability, and compliance with regulatory requirements.
2) Scope
This SOP applies to all documents generated, maintained, or used within the pharmaceutical manufacturing facility, including policies, procedures, specifications, batch records, and forms. It covers procedures for document creation, revision control, distribution, and archiving.
3) Responsibilities
– Quality Assurance (QA) Department: Ensures compliance with SOP and regulatory guidelines for document control.
– Document Control Coordinator: Manages document control processes, including revision control and distribution.
– Department Heads: Review and approve documents relevant to their respective departments.
4) Procedure
4.1 Document Creation
4.1.1 Develop new documents using approved templates and formats.
4.1.2 Assign unique document numbers and version control identifiers.
4.2 Document Review and Approval
4.2.1 Conduct initial review of documents by relevant stakeholders for accuracy and completeness.
4.2.2 Obtain approvals from designated personnel (e.g., department heads, QA) before finalizing documents.
4.3 Document Distribution
4.3.1 Distribute approved documents to relevant personnel or departments based on defined distribution lists.
4.3.2 Maintain records of document distribution and
4.4 Document Revision Control
4.4.1 Implement a document change control process to manage revisions, including change requests and approvals.
4.4.2 Update documents promptly upon approval of revisions and ensure obsolete versions are archived.
4.5 Document Retrieval and Archiving
4.5.1 Establish procedures for document retrieval to ensure timely access to current versions.
4.5.2 Archive superseded or obsolete documents in a controlled manner to prevent unintended use.
4.6 Document Training
4.6.1 Provide training to relevant personnel on document control procedures and responsibilities.
4.6.2 Maintain training records to demonstrate competence in document handling and use.
4.7 Documentation
4.7.1 Maintain comprehensive records of all document control activities, including creation, review, distribution, and archiving.
4.7.2 Ensure that all records are reviewed and approved by the QA department.
4.8 Reporting
4.8.1 Prepare periodic reports summarizing document control metrics, including document status, revisions, and training compliance.
4.8.2 Submit reports to the QA department for review, approval, and archiving.
5) Abbreviations, if any
– QA: Quality Assurance
– SOP: Standard Operating Procedure
6) Documents, if any
– Document Templates
– Document Change Request Forms
– Distribution Lists
7) Reference, if any
– FDA Guidance for Industry: Document Control and Documentation
– ICH Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
8) SOP Version
Version 1.0