Presse

Good Manufacturing Practice (GMP) is a term that is recognized worldwide for the control and management of manufacturing and quality control testing of foods, pharmaceutical products and medical devices. The GMP MANUAL is published in the paper version with approx. 3,500 pages in a series of 5 binders plus CD-ROM. This worldwide most extensive knowledge database in the field of GMP is also available as a CD-ROM version or as an online version at www.gmp-manual.com. As a how-to-do document for daily business in the pharmaceutical and related industries it is used in more than 60 countries around the world. Early this year - responding to increased demand - Maas & Peither 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.

The GMP MANUAL combines regulatory guidelines and their interpretation in practice.

GMP in Practice (part I) includes the following topics: Quality Management, Personnel, Quality Control, Documentation, Contract Manufacturing, Quality Tools, Premises, Qualification, Process Validation, Cleaning Validation, Computer System Validation, Production, Equipment, Packaging and Inspections, Pharmaceutical Water, Sterile Production, Research and Development, Active Pharmaceutical Ingredients.

GMP Regulations (part II) covers the most important GMP guidelines from EU, FDA, ICH, PIC/S, Japan and WHO, and a complete index.

There are hyper-linked cross-references throughout both parts. This flexible structure of the document (CD-ROM or Online) allows rapid identification and easy navigation within this valuable resource.

Updated 2-3 times a year by a team of more than 50 experts and key opinion leaders from the US and Europe, the GMP MANUAL provides reliable guidance in the field of GMP. Thus, ensuring clients to keep up-to-date with a continuously changing environment. Every article is reviewed by multiple experts from corresponding specialized fields. This peer review process guarantees the outstanding quality of the GMP MANUAL. As a testimony to this, the GMP MANUAL is on the recommendation list of selected international publications of the Parenteral Drug Association (PDA) and can be ordered through the PDA bookstore.

Maas & Peither 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 which 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 responded to the expanding demand of the international community.

Headquartered in Schopfheim (Germany) Maas & Peither is strategically located near the heart of the European pharmaceutical industry in Basel (Switzerland). A team of 14 employees is responsible for printing, distribution and shipping as well as customer service. Maas & Peither has alliances with partners around the world supporting them with the shipment of GMP MANUALs.

Find here the table of contents and an excerpt Documentation: example of an SOP

Price: GMP MANUAL plus CD-ROM: 695.- €, 2-3 updates per year, each approx. 160 € (excluding shipping and tax)
GMP MANUAL Online Corporate license (floating license): 2,100 € , Subscription fee: 1200 €/year