The full form of PQ in the pharmaceutical industry is Performance Qualification.
Performance Qualification (PQ) Explained
Performance Qualification (PQ) is a crucial step in the validation process of pharmaceutical equipment and processes. It's the documented evidence that the equipment or process performs effectively and reproducibly according to pre-approved specifications throughout the defined operating range. This ensures consistent product quality.
Key Aspects of Performance Qualification:
- Objective: To demonstrate that the equipment or process consistently produces a product meeting pre-determined quality attributes under normal operating conditions.
- Timing: PQ is typically conducted after Installation Qualification (IQ) and Operational Qualification (OQ) have been successfully completed. IQ verifies that the equipment is installed correctly, and OQ verifies that it operates as intended.
- Documentation: A comprehensive PQ protocol is essential. This protocol outlines the tests to be performed, acceptance criteria, and testing schedule. Results must be meticulously documented.
- Testing Parameters: PQ involves testing under various operating conditions, including worst-case scenarios, to assess the equipment's robustness and ensure consistent performance. This often includes assessing the impact of variations in raw materials, environmental conditions, and operator performance.
- Acceptance Criteria: Clearly defined acceptance criteria are established in the PQ protocol. The equipment or process must meet these criteria to be deemed qualified.
- Regulatory Compliance: PQ is a regulatory requirement in the pharmaceutical industry, ensuring compliance with Good Manufacturing Practices (GMP).
Example of PQ in Pharmaceutical Manufacturing:
Consider a tablet press. After IQ and OQ are complete, PQ would involve running the tablet press for extended periods under various conditions (e.g., different tablet sizes, compression forces, raw material batches) to verify that the tablets consistently meet quality specifications for weight, hardness, disintegration time, and drug content.
Stages of Validation:
The Validation process usually involves four steps in sequence. They are:
- Design Qualification (DQ)
- Installation Qualification (IQ)
- Operational Qualification (OQ)
- Performance Qualification (PQ)
