İlaç Endüstrisinde Proses Validasyonu ve Tasarımla Kalite (QbD) Yaklaşımı

SUMMARY Process validation, which is defined as documented evidence that the process, operated within established parameters, can perform effectively and reproducibly to produce a medicinal product meeting its predetermined specifications and quality attributes. Process validation incorporates a lifecycle approach linking product and process development, validation of the commercial manufacturing process and maintenance of the process in a state of control during routine commercial production. Many pharmaceutical companies are adopting the principles of Quality by Design (QbD) for pharmaceutical development and manufacturing, which enables enhanced process understanding, and a more systematic and scientific approach to pharmaceutical development, so that better controls can be implemented. Key Words: Drug production, Process validation ,Quality by Design (QbD) ,PAT, Continuous process verification ÖZ Proses validasyonu, belirlenmiş parametreler dahilinde yürütülen prosesin, önceden belirlenmiş spesifikasyonlan ve kalite özelliklerini karşılayan bir tıbbi ürünü üretmek için etkin ve tekrarlanabilir bir şekilde performans gösterebildiǧinin belgelenmiş kanıtıdır.