Qualifications and Validations

The three pillars of GMP are efficacy, safety and quality. At MG Health the focus is on Quality by Design which begins with the inception of a potential new process or equipment piece and is followed through the entire life cycle. The User Requirements Specification (URS) is the foundation of the qualification process and defines all the expectations of the equipment/process.

This is followed by the subsequent phases of qualification starting with a Design Qualification (DQ). During the DQ the proposed equipment design is measured against the user requirement. Once the design phase has been completed, the equipment is built to specification and installed. Following installation, the Installation Qualification (IQ) process starts and serves to ensure the received equipment follows the DQ. With the successful completion of the IQ, the Operation Qualification (OQ) tests the operation of the equipment to ensure that it operates as per its intended use.

Included in the OQ is ‘worst-case’ scenario testing to define the limits of the equipment. With these limits defined the final stage of the qualification is the Performance Qualification (PQ) which qualifies the performance of the equipment using processing material and production batch sizes. With the completion of the qualification process, there is a Process Validation Procedure (PVP) which is designed to illustrate a state of control and consistency from batch to batch. After each step, there is a thorough analysis of the results to define the limits and confirm a robust process that will ensure a consistently high-quality product.