İlaç Endüstrisinde Proses Validasyonu ve Tasarımla Kalite (QbD) Yaklaşımı

Öz

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. In the last decade, continuous process verification has been introduced, which is based on a continuous monitoring of manufacturing performance. This approach is based on the knowledge from product and process development studies and/ or previous manufacturing experiences. Continuous process verification may be applicable to both a traditional and enhanced approach to pharmaceutical development. 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. QbD is considered in examining validation within a product lifecycle framework. In this review, after reviewing the process validation approaches that are described in the current national and international guidelines, the focus will be on QbD and its significance in process validation.

Anahtar Kelimeler

• Drug production
• Process validation
• Quality by Design (QbD)
• PAT
• Continuous process verification

Kaynakça

1. Agalloco, J. (1995, Jul-Aug). Validation: an unconventional review and reinvention. PDA J Pharm SciTechnol, 49(4), 175-179.