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