Sterile Manufacturing: Regulations, Processes, and Guidelines
Sterile Manufacturing: Regulations, Processes, and Guidelines
English | 2022 | ISBN: 0367754355 | 207 Pages | PDF (True) | 11 MB
English | 2022 | ISBN: 0367754355 | 207 Pages | PDF (True) | 11 MB
This book highlights key ideas and factors to coach and guide professionals involved in learning about Sterile Manufacturing and operational requirements. It covers regulations and guidelines instituted by the FDA, ISPE, EMA, MHRA, and ICH, emphasizing good manufacturing practice and inspection requirements in the manufacturing of medicinal products.