Cleaning Validation Manual
Productivity Press (Verlag)
978-1-4987-7966-1 (ISBN)
- Titel ist leider vergriffen;
keine Neuauflage - Artikel merken
During the past decades, enormous progress and enhancement of pharmaceutical manufacturing equipment and its use have been made. And while there are support documents, books, articles, and online resources available on the principles of cleaning and associated processing techniques, none of them provides a single database with convenient, ready-to-use training tools. Until now. Cleaning Validation Manual: A Comprehensive Guide for the Pharmaceutical and Biotechnology Industries elucidates how to train the man power involved in development, manufacturing, auditing, and validation of bio pharmaceuticals on a pilot scale, leading to scale-up production.
With over 20 easy-to-use template protocols for cleaning validation of extensively used equipments, this book provides technical solutions to assist in fulfilling the training needs of finished pharmaceutical manufacturers. Drawing on the authors’ more than two decades of experience in the pharmaceutical and biotech industries, the text offers hands-on training based on current approaches and techniques. The book does not merely provide guidelines or thought processes, rather it gives ready-to-use formulas to develop Master Plan, SOPs, and validation protocols. It includes cleaning procedures for the most commonly used equipment in various manufacturing areas and their sampling points, using a pharmaceutical manufacturing site with both sterile and non-sterile operations as the case facility. It also provides the training guidelines on downloadable resources to enable users to amend or adopt them as necessary.
Grounded in practicality, the book’s applicability and accessibility set it apart. It can be used as a guide for implementing a cleaning validation program on site without the help of external consultants, making it a resource that will not be found collecting dust on a shelf, but rather, referred to again and again.
Syed Imtiaz Haider is a long standing professional in the biopharmaceutical industry, largely based in the United Arab Emirates. He has over 25 years in direct line supervision in all quality control aspects of biopharmaceuticals. He is currently the Chief Scientist at the Gulf Pharmaecutical Industrie in Saudi Arabia. Dr. Haider has published 7 books in related technologies and published over150 pagers in biopharmaceutical research and development.
How to Establish a Cleaning Validation Program. Introduction. Scope and Approach. Cleaning Validation Team Members and Responsibilities. Cleaning Validation Philosophy. Planning Phase; Analytical Testing and Reporting Phase. Equipment Description. Facility Description. Utilies Description. Utilities Monitoring and Microbiological Controls. Microbiological Cleaning of Equipment Surfaces. Solubility of Active Materials in Water. Toxicity of Active Materials. Cleaning Validation Products Grouping Matrix. Product Equipment Training Matrix. Cleaning Validation Protocols for Fluid Bed Dryer. for Mixer. for Granulation Machines. for Powder Bins. for Sieve. for Encapsulation Machines. for Protocol Pans. Cleaning Validation Protocol for Freeze Dryer. for Glass- Lined Mobile Tank. WHO Good Manufacturing Guidelines for Cleaning Validation.Health Products and Food Branch Inspectorate Guidance Document Cleaning Validation Guidelines. Qualification and Validation. Sampling Tools. Recommended Readings.
| Erscheint lt. Verlag | 31.12.2019 |
|---|---|
| Verlagsort | Portland |
| Sprache | englisch |
| Maße | 178 x 254 mm |
| Themenwelt | Medizin / Pharmazie ► Medizinische Fachgebiete ► Laboratoriumsmedizin |
| Naturwissenschaften ► Biologie | |
| Technik ► Umwelttechnik / Biotechnologie | |
| ISBN-10 | 1-4987-7966-2 / 1498779662 |
| ISBN-13 | 978-1-4987-7966-1 / 9781498779661 |
| Zustand | Neuware |
| Haben Sie eine Frage zum Produkt? |
aus dem Bereich
