Process validation is defined as the collection and evaluation of data, from the process design stage through commercial production, which establishes scientific evidence that a process is capable of consistently delivering quality product. Process validation involves a series of activities taking place over the life cycle of the product and process. Process validation has 3 stages: Process Design, Process Qualification, and Continued Process Verification. In the Process Design, the commercial manufacturing process is defined during this stage based on knowledge gained through development and scale-up activities. In the Process Qualification, the process design is evaluated to determine if the process is capable of reproducible commercial manufacturing. In Continued Process Verification, Ongoing assurance is gained during routine production that the process remains in a state of control. A successful validation program depends upon information and knowledge from product and process development. This knowledge and understanding is the basis for establishing an approach to control of the manufacturing process that results in products with the desired quality attributes. Manufacturers should understand the sources of variation, detect the presence and degree of variation, understand the impact of variation on the process and ultimately on product attributes, and control the variation in a manner commensurate with the risk it represents to the process
and product.
Based on the FDA website, there are steps to make a design validation better. Each manufacturer shall establish and maintain procedures for validating the device design. Design validation shall be performed under defined operating conditions on initial production units, lots, or batches, or their equivalents. Design validation shall ensure that devices conform to defined user needs and intended uses and shall include testing of production units under actual or simulated use conditions. Design validation shall include software validation and risk analysis, where appropriate. The results of the design validation, including identification of the design, method(s), the date, and the individual(s) performing the validation, shall be documented in the Design History File.