GMP MANUAL Volume 2 - Validation Procedures by Maas & Peither AG – GMP Publishing
|Pressemitteilung von: Maas & Peither AG, GMP-Publishing|
(openPR) - GMP Publishing is launching its new GMP MANUAL Volume 2 – Validation Procedures. |
The compendium on validation procedures was written by Dr. Doris Borchert, Dr. Peter Bosshard, Dr. Ralph Gomez, Dr. Michael Hiob, Dr. Christine Oechslein, Max Lazar, Ulrike Reuter, Michael Schulte, Uwe Schwarzat – all international experts and key opinion leaders. They share their detailed understanding of the various aspects of the validation process in clear and comprehensive style on approx. 500 pages. The book is an excerpt from the GMP MANUAL, the worlds leading comprehensive reference book in the field of GMP and tailored towards people who need a concise and authoritative how-to-do document for daily business. It offers the perfect tool for them to keep up-to-date with a constantly changing environment.
GMP MANUAL Volume 2 – Validation Procedures is divided into four chapters: qualification, process validation, cleaning validation and computer validation. Every part starts with an overview on regulatory requirements. The first chapter explains, amongst others, all aspects of preparations of qualifications, documentation and installation. Here the reader will also find some detailed information on how to deal with special cases of qualifications like content of a review or maintenance of the qualified status. Process Validation is the topic of the second chapter. It covers a validation master plan, risk analysis and a helpful guide for creating protocols and reports. The third chapter contains GMP-related information around cleaning validation dedicating extra chapters to sampling procedures and analytical procedures. Last but not least there is a chapter on computer validation which, after explaining basic terminology, offers facts and information on the life cycle of software and systems.
GMP MANUAL Volume 2 – Validation Procedures
Maas & Peither – GMP Publishing was founded by Anita Maas, Barbara Peither, and Thomas Peither in Germany in 1999 with the vision of providing their colleagues in industry and regulatory authorities with a resource that enables them to implement and maintain GMP regulations. In 2000 they released the first GMP-BERATER in German which soon became a market leader and standard reference work in the pharmaceutical and related industries. In 2006 was the first release of the GMP MANUAL – the English version of the GMP BERATER. By extending their portfolio Maas & Peither – GMP Publishing responded to the expanding demand of the international community. Headquartered in Schopfheim (Germany) Maas & Peither – GMP Publishing is strategically located near the heart of the European pharmaceutical industry in Basel (Switzerland). Maas & Peither – GMP Publishing has alliances with partners around the world supporting them with the distribution and shipment of GMP MANUALs. Early this year responding to increased demand GMP Publishing has decided to put the growing community of their American customers in the center of their efforts. Opening a new office in Philadelphia, PA the company can now provide immediate, high quality service and respond to all its clients’ needs in the USA and Canada.
Thomas Peither +49/ 7622/ 666 86 70
Maas & Peither AG
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