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 any results that do not meet acceptance criteria for further investigation.
4.5 Reporting and Documentation
4.5.1 Prepare in-process testing reports and ensure they are reviewed and approved by QA.
4.5.2 Maintain complete and traceable records of all in-process testing activities.
5) Abbreviations, if any
SOP: Standard Operating Procedure
QC: Quality Control
QA: Quality Assurance
6) Documents, if any
– In-process Testing Records
– SOP for Sampling and Testing Procedures
– Specifications for In-process Parameters
7) Reference, if any
– USP <1116> Microbiological Control and Monitoring of Aseptic Processing Environments
– ICH Q2(R1): Validation of Analytical Procedures
– Company-specific quality control and testing guidelines
8) SOP Version
Version 1.0