Standard Operating Procedure for Document Control and Management
1) Purpose
The purpose of this Standard Operating Procedure (SOP) is to establish procedures for the control, distribution, storage, retrieval, and archiving of documents within the pharmaceutical manufacturing facility to ensure compliance with regulatory requirements and facilitate efficient document management.
2) Scope
This SOP applies to all documents generated, maintained, and controlled within the pharmaceutical manufacturing facility, including SOPs, batch records, protocols, reports, and forms. It covers procedures for document creation, revision control, review, approval, distribution, retention, and archiving.
3) Responsibilities
– Quality Assurance (QA) Department: Oversees document control and management activities to ensure compliance with SOP and regulatory requirements.
– Document Owners: Create, review, and approve documents in accordance with approved procedures and timelines.
– Document Control Officer: Maintains the document control system, including document numbering, version control, and archival processes.
4) Procedure
4.1 Document Creation and Revision
4.1.1 Develop documents using approved templates and formats that include clear objectives, responsibilities, and procedural steps.
4.1.2 Assign unique document numbers, version identifiers, and effective dates to each document for traceability.
4.2 Document Review and Approval
4.2.1 Conduct initial review of documents by relevant personnel (e.g., document owners, QA) to ensure accuracy, completeness, and compliance.
4.2.2 Obtain approvals from designated personnel (e.g., QA Manager, Department Heads) before finalizing documents for distribution and use.
4.3 Document Distribution
4.3.1 Distribute approved documents to relevant departments and individuals in electronic or hard copy format as per distribution matrix.
4.3.2 Maintain records of document distribution and acknowledge receipt from recipients.
4.4 Document Storage and Retrieval
4.4.1 Store documents in a secure, organized manner to prevent loss, damage, or unauthorized access.
4.4.2 Establish procedures for the retrieval of documents in response to regulatory inspections, audits, or operational needs.
4.5 Document Revision Control
4.5.1 Implement a document change control process to manage revisions, including revision history, rationale for changes, and approvals.
4.5.2 Ensure that only current and approved versions of documents are available for reference and use.
4.6 Document Archiving
4.6.1 Archive obsolete or superseded documents in a controlled manner to maintain document integrity and accessibility for future reference.
4.6.2 Label archived documents with document numbers, version identifiers, and archival dates for easy retrieval and traceability.
4.7 Documentation
4.7.1 Maintain comprehensive records of document creation, review, approval, distribution, revision, storage, retrieval, and archiving activities.
4.7.2 Ensure that all records are legible, accurate, and readily accessible for review by regulatory authorities.
4.8 Reporting
4.8.1 Prepare periodic reports summarizing document control and management activities, including compliance status, issues identified, and corrective actions taken.
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
– SOPs (Standard Operating Procedures)
– Batch Records
– Protocols and Reports
7) Reference, if any
– FDA Guidance for Industry: Document Control and Management Systems
– ICH Q10 Pharmaceutical Quality System
8) SOP Version
Version 1.0
