Standard Operating Procedure for In-process Testing for Gels

1) Purpose

The purpose of this SOP is to outline procedures for conducting in-process testing during the manufacturing of gels to ensure product quality, consistency, and compliance with specifications.

2) Scope

This SOP applies to all personnel involved in the production and testing of gels within the pharmaceutical manufacturing facility.

3) Responsibilities

Quality Control (QC) Analyst: Perform in-process testing according to this SOP.
Production Operators: Collect samples and assist in testing procedures as required.
Quality Assurance (QA) Team: Review and approve in-process testing results.

4) Procedure

4.1 Sampling
4.1.1 Collect representative samples at specified stages of the manufacturing process.
4.1.2 Follow sampling procedures to ensure samples are taken aseptically and accurately.

4.2 Testing Methods
4.2.1 Perform tests as per approved methods and specifications for each in-process stage.
4.2.2 Include tests such as viscosity, pH, clarity, homogeneity, and any other relevant parameters.

4.3 Recordkeeping
4.3.1 Document all in-process testing activities promptly and accurately.
4.3.2 Record test results, observations, and any deviations from expected outcomes.

4.4 Evaluation and Acceptance Criteria
4.4.1 Evaluate test results against established acceptance criteria.
4.4.2 Notify production and QA of