GMP Publishing is launching its new GMP MANUAL Volume 1 - Manufacturing. The book is intended to support staff in the pharmaceutical production field by providing internationally accepted GMP guidance.
International GMP experts share their knowledge of GMP implementation according to GMP regulations of the FDA, Europe, ICH, PIC/S and WHO. The reader is learning how leading industry experts solve challenges and improve and refine procedures accordingly. The book answers quality related questions that affect daily business.
The compendium on manufacturing was written by Dr. Helmut Bender, Dr. Christian Gausepohl, Dr. Ralph Gomez, Dr. Michael Hiob, Dr. Josef Kuenzle, Paolomi Mukherji, Michael Schulte, Dr. Hanfried Seyfarth, and Cornelia Wawretschek, all experts and key opinion leaders in the field of GMP from the US and Europe. The writers' expertise combined with a peer review process ensures up-to-date and authentic guidance in the field of GMP.
The book is an excerpt from the GMP MANUAL, the world's 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 is helpful to people responsible for GMP in all areas of pharmaceutical manufacturing or in charge of conducting GMP-audits. It offers the perfect tool to keep up-to-date with a constantly changing environment.
The book is divided in four chapters: production, packaging, laboratory and analytical controls, and documentation. Every part starts with an overview of questions that will be answered in the following chapter and ends with a brief summary.
The first chapter on production explains amongst others all aspects of sanitation, personal and production hygiene, environmental monitoring, and in process-control. A special part offers tips on how to deal with deviations and how deviations are documented. Packaging is the topic of the second chapter and covers all aspects of the packaging process on ninety pages. The third chapter contains GMP-related information around laboratory and analytical controls. Last but not least the reader will find a chapter about documentation. According to FDA statistics poor documentation is one of the main issues for audit complaints. The chapter starts with official and legal requirements (US as well as EU) in relation to documentation - which formal aspects must be observed, how should documents be structured, managed, and reviewed. In addition the compendium carries on more than 50 pages of a collection of sample documents which can be adapted for the specific needs of the reader.
To order, visit: www.gmp-publishing.com, call: +49 7622 666 8670 or e-mail: service@gmp-publishing.com
