Standard Operating Procedure for Documentation Control in Gels Production
1) Purpose
The purpose of this SOP is to establish procedures for the creation, revision, distribution, storage, and retention of documents related to gels production to ensure accuracy, traceability, and compliance with regulatory requirements.
2) Scope
This SOP applies to all personnel involved in document creation, management, and control within the pharmaceutical manufacturing facility’s gels production department.
3) Responsibilities
Quality Assurance (QA) Team: Oversee the document control process and ensure compliance with SOPs.
Document Control Officer: Manage document lifecycle, including creation, revision, and archiving.
Production Department: Follow document control procedures during the production process.
Training Department: Ensure personnel are trained on document control procedures.
4) Procedure
4.1 Document Creation and Review
4.1.1 Identify the need for a new document or revision based on operational changes or regulatory updates.
4.1.2 Draft the document using approved templates and ensure it includes required information.
4.2 Document Approval
4.2.1 Review and approve documents by designated personnel, ensuring accuracy and compliance.
4.2.2 Obtain signatures from authorized personnel, including QA and relevant department heads.
4.3 Document Distribution
4.3.1 Distribute approved documents to relevant departments and personnel electronically or in hard copy.
4.3.2 Maintain distribution records to track document dissemination and receipt.
4.4 Document Storage and Access
4.4.1 Store documents in a secure, controlled environment to prevent unauthorized access, damage, or loss.
4.4.2 Ensure documents are organized and easily retrievable for audits and reviews.
4.5 Document Retrieval and Obsoletion
4.5.1 Establish procedures for retrieving documents for review, revision, or obsoletion as necessary.
4.5.2 Obsolete outdated documents promptly and update document indices and databases accordingly.
4.6 Document Retention
4.6.1 Define retention periods for various types of documents based on regulatory requirements and business needs.
4.6.2 Archive documents securely after the retention period expires or as per document control procedures.
5) Abbreviations, if any
SOP: Standard Operating Procedure
QA: Quality Assurance
6) Documents, if any
– Document Control Procedures
– Document Templates (e.g., SOP templates, batch record templates)
– Document Distribution Records
7) Reference, if any
– FDA CFR 21 Part 211: Current Good Manufacturing Practice for Finished Pharmaceuticals
– ICH Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
– Company-specific document control policies and guidelines
8) SOP Version
Version 1.0