Ostrove Equipment Qualification in the Pharmaceutical Industry

Erscheinungsjahr 2019
ISBN: 978-0-12-817568-2
Verlag: Elsevier Science Publishing Co Inc

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Beschreibung

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.

Equipment Qualification in the Pharmaceutical Industry provides students and pharmaceutical scientists a guideline for the preparation and execution of qualification (installation, operational, and performance) protocols.



- Incorporates good manufacturing processes into a compliant qualification program
- Provides examples of protocol layout
- Includes matrices for major process equipment, installation quality, operational quality, and performance quality requirements

Autoren

Autoren

Ostrove, Steven (Ostrove Associates, Inc. Elizabeth, NJ, USA)

Ostrove, Steven

Über den Autor

Ostrove, Steven
Dr. Ostrove has over 30 years of experience in validation compliance, quality assurance, and regulatory affairs. In addition, he has developmental and process expertise in mammalian cell culture and separation technology. His general pharmaceutical experience includes sterile techniques (Aseptic processing), Process Validation, Cleaning and Sterilization Validation, Packaging Systems, Process Development and Process Scale-up. He also has industry experience with the development and validation of PC and PLC-based computer control systems for the biotech and pharmaceutical markets, guidance on system optimization for CIP/SIP and has led teams for the review of all GMP documents starting with their preparation (e.g., protocols, SOPs, and validation master plans). Dr. Ostrove has worked on several consent degree remediation and audit teams and his experience covers both EU and US regulations. He is the author of the Elsevier short format book How to Validate a Pharmaceutical Process (Jun 2016, 9780128041482).

Inhaltsverzeichnis

1. Introduction 2. Documentation - Getting Ready 3. Quality Systems 4. Equipment Design Considerations 5. Equipment Controls and Automation 6. Preparing the Protocols - General Approach 7. Commissioning & Decommissioning 8. Equipment Qualification Protocols 9. Equipment Checklist 10. Protocol Execution 11. Protocol Reports

Appendix A. Definitions B. Examples C. References

Zielgruppe

<p>Postgraduate Pharmaceutical Science students, Postdoctoral Pharmaceutical Scientists, Biomedical and Pharmaceutical Engineers, those working in Quality Assurance, Quality Control and Validation professionals, as well as students of engineering</p>

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