Equipment Qualification in the Pharmaceutical Industry
Series: Aspects of Pharmaceutical Manufacturing;
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42 966 Ft
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Product details:
- Publisher Elsevier Science
- Date of Publication 14 June 2019
- ISBN 9780128175682
- Binding Paperback
- No. of pages234 pages
- Size 229x152 mm
- Weight 360 g
- Language English 0
Categories
Long description:
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.
MoreTable of Contents:
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
AppendixA. DefinitionsB. ExamplesC. References
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