Standard Operating Procedure for Documentation in Gels Production
1) Purpose
The purpose of this SOP is to establish guidelines for the documentation practices in the production of gels to ensure accuracy, completeness, and compliance with regulatory requirements.
2) Scope
This SOP applies to all personnel involved in documentation activities within the pharmaceutical manufacturing facility where gels are produced.
3) Responsibilities
Documentation Control Officer: Oversee documentation procedures and maintain document control.
Production Operators: Complete production records accurately and in a timely manner.
Quality Assurance (QA) Personnel: Review and approve documentation for completeness and compliance.
4) Procedure
4.1 Document Creation and Preparation
4.1.1 Use approved templates and forms for creating production documents (e.g., batch records, logbooks).
4.1.2 Include all necessary information such as batch numbers, dates, materials used, and process steps.
4.2 Recording of Information
4.2.1 Record production data in real-time during each stage of gel manufacturing.
4.2.2 Use clear and legible handwriting or electronic entry for data recording.
4.3 Review and Approval
4.3.1 Review completed documents for accuracy, consistency, and compliance with SOPs.
4.3.2 Obtain necessary approvals from authorized personnel before proceeding to the next production stage.
4.4 Document Retention and Storage
4.4.1 Store completed documents in designated areas with appropriate labeling and indexing.
4.4.2 Ensure documents are retained as per regulatory requirements and company policies.
4.5 Document Control
4.5.1 Implement document version control to manage revisions and updates.
4.5.2 Archive obsolete documents securely and maintain a documented history of changes.
5) Abbreviations, if any
SOP: Standard Operating Procedure
QA: Quality Assurance
6) Documents, if any
– Batch Production Records
– Logbooks for Equipment and Facility Monitoring
– Document Change Control Forms
7) Reference, if any
– FDA Regulations on Good Documentation Practices (GDP)
– ICH Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
– Company-specific document management procedures
8) SOP Version
Version 1.0
