“Key Responsibilities of the Qualification Department in Pharma”
“Key Responsibilities of the Qualification Department in Pharma”
The qualification department plays a key role in the pharmaceutical industry by ensuring that all equipment, processes, and systems are thoroughly tested and validated to meet regulatory and operational standards. The department follows a systematic approach to qualification, ensuring that each phase of the equipment’s lifecycle—design, installation, operation, and performance—meets the required specifications.
Major Responsibilities:
- Design Qualification (DQ): This stage verifies that the equipment’s design meets predefined requirements. It involves collaboration between the equipment manufacturer and the pharmaceutical company to ensure that all functional, safety, and operational needs are addressed before the equipment is built or deployed. Early detection of design flaws in this phase reduces the need for costly changes later on.
- Installation Qualification (IQ): IQ confirms that equipment is installed according to its design and technical specifications. It ensures that all supporting infrastructure, such as utilities and environmental controls, meets the necessary standards. Proper documentation and labeling are completed, preparing the equipment for operational testing.
- Operational Qualification (OQ): OQ tests the equipment under different operating conditions to ensure it functions as expected. The equipment is assessed for its performance under both standard and extreme conditions, verifying that it consistently meets operational requirements. This phase ensures that safety features, control systems, and overall performance are functioning correctly.
- Performance Qualification (PQ): PQ is conducted in real production settings to confirm that the equipment consistently produces products that meet quality and regulatory standards. It validates the equipment’s ability to maintain reliable performance during actual operations, ensuring that the product’s quality remains uncompromised. This is done by taking some runs of machine with real products to see the performance
The qualification department ensures that all equipment and processes are reliable, safe, and compliant with regulatory guidelines, minimizing risks and ensuring smooth production operations.