Standard Operating Procedure for Process Validation Protocols for Gels

1) Purpose

The purpose of this SOP is to define the procedures for conducting process validation protocols for gels production to ensure consistent product quality, reliability, and compliance with regulatory requirements.

2) Scope

This SOP applies to all stages of the process validation lifecycle, including process design, qualification, and continued process verification, within the pharmaceutical manufacturing facility’s gels production department.

3) Responsibilities

Quality Assurance (QA) Team: Develop and oversee implementation of process validation protocols.
Production Managers: Execute process validation activities and ensure adherence to protocols.
Validation Specialists: Perform data collection, analysis, and reporting related to process validation.

4) Procedure

4.1 Process Design
4.1.1 Define critical process parameters (CPPs) and their acceptable ranges based on product specifications and regulatory requirements.
4.1.2 Develop process flow diagrams and control strategies to ensure consistent product quality.

4.2 Installation Qualification (IQ)
4.2.1 Verify that equipment and utilities are installed correctly and meet operational specifications.
4.2.2 Document installation qualification activities and observations.

4.3 Operational Qualification (OQ)
4.3.1 Perform operational tests to demonstrate that the equipment operates within specified limits.
4.3.2 Document operational qualification protocols and results.

4.4 Performance Qualification (PQ)