Successful process validation assures drug quality. The fundamental rule in quality assurance is that if a drug is produced, it must be fit for its intended use. This rule incorporates the understanding that conditions like a) quality, efficacy and safety are built into the product b) quality should not be assured just by testing the in-process and final-product.
1. Approach to Process Validation
Process validation is the compilation and valuation of data, right from the design stage to production, which creates scientific evidence that a process is eligible of delivering quality product consistently. Process validation involves a lot of activities happening over the lifecycle of the product as well as process. This guidance explains the activities of process validation in three stages -- process design, continued process verification and process qualification.
2. Process Qualification
During the process qualification (PQ) phase of the process validation, the process design is assessed to establish if it is capable of reproducible commercial manufacture. There are two elements in this stage: 1) designing the facility and qualification of the utilities and equipment and 2) process performance qualification (PPQ). During process performance qualification, Current Good Manufacturing Practices (CGMP) compliant procedures must be followed.
3. Continued Process Verification
The aim of the third validation stage is persistent assurance that the process remains in a validated state (state of control) during commercial manufacture. A system for checking unintended departures from the process as designed is important to achieve this goal. Complying with the CGMP regulations, purposely, the collection and valuation of information and data about the process performance, will allow detection of undesired process variability.