By Holger Shen, Bora Pharmaceuticals
The Process Validation (PV) Guidance from the FDA (January 2011) adopts the product lifecycle concept, emphasizing the expectation that process validation starts with process design and carries throughout the entire lifecycle of a commercial product. During the process qualification stage, the process design is evaluated to determine if the process is capable of consistently delivering quality products. The goal of Process Validation is to confirm the process design and demonstrate that the commercial manufacturing process performs as expected.
Process validation occurs in a series of activities taking place over the lifecycle of a product and its process. The product lifecycle is comprised of three stages including process design as Stage I, process qualification as Stage II, and continued process verification as Stage III, in compliance with relevant regulations.