Standard Operating Procedure for Process Validation

1) Purpose

This SOP outlines the procedures for conducting process validation studies to ensure that manufacturing processes consistently produce pharmaceutical products meeting predefined quality attributes and specifications.

2) Scope

This SOP applies to all stages of process validation, including process design, qualification, and continued process verification, within the pharmaceutical manufacturing operations.

3) Responsibilities

The Validation department or designated personnel are responsible for planning, executing, and documenting process validation activities. Production, Quality Assurance (QA), and Engineering departments are responsible for providing necessary support and ensuring compliance with validation requirements.

4) Procedure

4.1 Process Design (Stage 1)

1. Define critical process parameters (CPPs) and their acceptable ranges based on product and process knowledge.
2. Develop a process flow diagram and identify potential sources of variability.
3. Perform risk assessment to identify and prioritize critical process steps.

4.2 Process Qualification (Stage 2)

1. Perform Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) to verify that equipment and processes operate as intended.
2. Conduct process simulations or trials under controlled conditions to demonstrate process capability.
3. Collect and analyze data to establish process control limits and acceptance criteria.

4.3 Continued Process Verification (Stage 3)

1. Implement ongoing monitoring and verification activities to ensure the process remains in a state of control.
2. Monitor key performance indicators