Qualifying master and working cell banks.When the 1987 FDA guidance was published, validation during early stages of product development (before Phase 1 clinical trials) was minimal: This definition has since been adopted in guidance documents worldwide, including the current good manufacturing practices (cGMP) regulations promulgated by European regulatory agencies and the International Conference on Harmonisation (ICH). The principles of process validation were initially established in the 1987 US Food and Drug Administration (FDA) document “Guideline on General Principles of Process Validation,” which defined process validation as “establishing documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its pre-determined specifications and quality attributes.” 1 Manufacturing processes should be validated by applying a scientifically rigorous and well-documented exercise demonstrating that the process, and every piece of equipment used in it, consistently performs as intended, and that the process, when operated within established limits, generates a product that routinely and reliably meets its required quality standards. This entails removing impurities and contaminants that include endotoxins, viruses, cell membranes, nucleic acids, proteins, culture media components, process chemicals, and ligands leached from chromatography media, as well as product modifications, aggregates, and inactive forms. Manufacturing processes for biopharmaceuticals must be designed to produce products that have consistent quality attributes. Process validation today is a continual, risk-based, quality-focused exercise that encompasses the entire product life cycle.
0 kommentar(er)
