Equipment Qualification in the Pharmaceutical Industry (Aspects of Pharmaceutical Manufacturing)

Equipment Qualification in the Pharmaceutical Industry provides guidance that needs to be included in quality qualification programs. The book outlines guidelines for the preparation and execution of qualification protocols, including Installation (IQ), Operational (OQ), and Performance (PQ) factors. In addition, it discusses the importance of related qualification programs (e.g., computer system and cleaning) and how to incorporate them into a fully compliant qualification program. Further, it provides matrices of what could be included for major types of process equipment. While primarily for people entering the pharmaceutical industry, those established in the field will benefit from the examples, matrices, and integration of related systems.

• | Author: Steven Ostrove
• | Publisher: Academic Press
• | Publication Date: Jun 14, 2019
• | Number of Pages: 234 pages
• | Language: English
• | Binding: Paperback
• | ISBN-10: 0128175680
• | ISBN-13: 9780128175682