Document Control Procedures

1) Purpose

The purpose of this SOP is to establish standardized procedures for managing the creation, approval, distribution, and archiving of documents to ensure accurate and up-to-date documentation within the pharmaceutical manufacturing facility.

2) Scope

This SOP applies to all controlled documents within the pharmaceutical manufacturing facility, including SOPs, batch records, specifications, and quality manuals.

3) Responsibilities

– Document Control personnel are responsible for managing document control activities.
– QA personnel are responsible for reviewing and approving controlled documents.
– Department managers are responsible for ensuring that their team members comply with document control procedures.

4) Procedure

1. Document Creation
1.1. Identify the need for a new document or revision to an existing document.
1.2. Draft the document using the approved template, ensuring clarity and accuracy.
1.3. Include a unique document number, version number, and effective date.
2. Document Review and Approval
2.1. Submit the draft document to the relevant department for review.
2.2. Incorporate any feedback and make necessary revisions.
2.3. Submit the revised document to the QA department for final approval.
2.4. Obtain signatures from authorized personnel to approve the document.
3. Document Distribution
3.1. Distribute approved documents to relevant departments and personnel.
3.2. Ensure that only the most current versions of documents are in use.
3.3. Maintain a distribution log to track the dissemination of controlled documents.
4. Document Control
4.1. Store controlled documents in a secure and easily accessible location.
4.2. Implement a document control system to manage document versions and revisions.
4.3. Regularly review and update documents to ensure they remain current and relevant.
5. Document Archiving
5.1. Archive obsolete or superseded documents in a secure location.
5.2. Maintain an archive log to track archived documents and their retention periods.
5.3. Ensure that archived documents are retrievable for regulatory inspections and audits.
6. Handling Document Changes
6.1. Initiate a Document Change Request (DCR) for any revisions to controlled documents.
6.2. Follow the review and approval process for document changes.
6.3. Update the document control system to reflect the changes.
7. Training
7.1. Train all relevant personnel on document control procedures.
7.2. Provide regular refresher training and updates on any changes to document control policies.
7.3. Document all training activities in the training log.
8. Audits and Inspections
8.1. Conduct regular internal audits to ensure compliance with document control procedures.
8.2. Prepare for external audits and inspections by regulatory authorities.
8.3. Address any findings from audits and implement corrective actions as needed.

5) Abbreviations, if any

– QA: Quality Assurance
– SOP: Standard Operating Procedure
– DCR: Document Change Request

6) Documents, if any

– Document Control Template
– Document Review Log
– Distribution Log
– Archive Log
– Training Log

7) Reference, if any

– FDA 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
– ISO 9001:2015 – Quality Management Systems

8) SOP Version

Version 1.0