Process validation is the process for establishing documented evidence to provide a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality characteristics. Process validation is a key element in assuring that these quality assurance goals are met. Proof of validation is obtained through collection and evaluation of data, preferably beginning at the process development phase and continuing through the production phase.
[wp_ad_camp_4]The product’s end use should be a determining factor in the development of product (and component) characteristics and specifications. All pertinent aspects of the product that may affect safety and effectiveness should be considered. These aspects include performance, reliability, and stability. Acceptable ranges or limits should be established for each characteristic to set up allowable variations. Specifications are the quality standards (ie, tests, analytical procedures, and acceptance criteria) that confirm the quality of drug substances, drug products, intermediates, raw material reagents, components, in-process material, container closure systems, and other materials used in the production of the drug substance or drug product.
Through careful design and validation of both the process and process controls, a manufacturer can establish with a high degree of confidence that all manufactured units from successive lots will be acceptable. Successfully validating a process may reduce the dependence on intensive in-process and finished product testing. In most cases, end-product testing plays a major role in assuring that quality assurance goals are met; ie, validation and end-product testing are not mutually exclusive.