Good manufacturing practice (GMP) is a cornerstone in the regulated production of pharmaceuticals. As a result of historical accidents like the thalidomide disaster around 1960, regulations have evolved into a quality system that is nowadays called GMP. The main focus of GMP is to control preparation of pharmaceuticals during all stages of the manufacturing process. Both traceability of the product as well as of all production parameters and quality control data are assured by a quality system. This quality system consists of standard procedures meant to guide personnel through its dedicated tasks as well as monitoring data forms to fill out. Furthermore, all batch documentation is used for proper registration of batch related data. This book chapter focuses on GMP dedicated to PETradiopharmaceuticals. Thus, all relevant items regarding this theme are briefly discussed, such as design and development of hotcells and cleanroom facilities, qualification and validation, starting materials and clothing procedures. We conclude that GMP is important in order to be able to ensure patient safety and manufacturing concistency. Furthermore, to sustain operational flexibility for PET-preparations, a pragmatic, risk-based approach regarding GMP is needed.
|Titel||Trends on the Role of PET in Drug Development|
|Redacteuren||Philip H. Elsinga, Aren van Waarde, Anne M. J. Paans, Rudi A. J. O. Dierckx|
|Uitgeverij||World Scientific Publishing Co., Singapore|
|ISBN van elektronische versie||9789814317740|
|ISBN van geprinte versie||981431773X, 9789814317733|
|Status||Published - 2021|