Equipment Qualification in the Pharmaceutical Industry

Provides a guideline for the preparation and execution of qualification (Installation, Operational, and Performance) protocols

Steven Ostrove (Author)

9780128175682, Elsevier Science

Paperback, published 14 June 2019

234 pages
22.9 x 15.1 x 1.6 cm, 0.36 kg

Equipment Qualification in the Pharmaceutical Industry provides guidance and basic information for the preparation of a quality qualification program. It has been noted that there is a general lack of understanding in the industry, especially for those new to the industry, as to what constitutes a compliant qualification program. Even experienced professionals have felt a lack of security in reaching a compliant state. This book outlines a guideline for the preparation and execution of qualification protocols including the installation (IQ), operational (OQ), and performance (PQ) protocols. It discusses the importance of related qualification programs (e.g., quality systems, commissioning, computer system, and cleaning) and how to incorporate them into a fully compliant qualification program. Furthermore, it provides matrices of what could be included in each type of protocol for major types of process equipment. While primarily for people entering the pharmaceutical industry, those established in the field will benefit from the multiple examples and matrices as well as integration of related systems.

1. Introduction2. Documentation - Getting Ready 3. Quality Systems4. Equipment Design Considerations5. Equipment Controls and Automation6. Preparing the Protocols - General Approach7. Commissioning & Decommissioning8. Equipment Qualification Protocols9. Equipment Checklist10. Protocol Execution11. Protocol Reports

Subject Areas: Biochemistry [PSB], Life sciences: general issues [PSA], Organic chemistry [PNN], Biophysics [PHVN], Medical study & revision guides & reference material [MR], Pharmacy / dispensing [MQP], Pharmacology [MMG], Cytology [MFCC], Epidemiology & medical statistics [MBNS], Pharmaceutical industries [KNDP], Production & quality control management [KJMV5]