The FDA and Worldwide Current Good Manufacturing Practices and Quality System Requirements Guidebook for Finished Pharmaceuticals

Rodriguez-Perez, Jose (Pepe)

Omschrijving

Good Manufacturing Practices (GMP) for human pharmaceuticals affects every patient taking a medicine. GMP covers all aspects of the manufacturing process, from defining manufacturing processes to systems for recall and investigation of complaints. Consumers expect that each batch of medicines they take will meet quality standards so that they will be safe and effective. GMPs provide for systems that assure proper design, monitoring, and control of manufacturing processes and facilities. This formal system of controls at a pharmaceutical company, if adequately put into practice, helps to prevent instances of contamination, mix-ups, deviations, failures, and errors. This assures that drug products meet their quality standards. This guidance book is meant as a resource to manufacturers of pharmaceuticals, providing up-to-date information concerning required and recommended quality system practices. It should be used as a companion to the regulations/standards themselves and texts on the specific processes and activities contained within the QMS. As a bonus, this package contains dozens of FDA guidance documents as well as international harmonization documents (WHO, PIC/S, and ICH). A check list for GMP audit is also included based on risk management criteria. An exam complements the extra material.
Gratis verzending vanaf
€ 19,95 binnen Nederland
Schrijver
Rodriguez-Perez, Jose (Pepe)
Titel
The FDA and Worldwide Current Good Manufacturing Practices and Quality System Requirements Guidebook for Finished Pharmaceuticals
Uitgever
ASQ Quality Press
Jaar
2014
Taal
Engels
Pagina's
394
Gewicht
998 gr
EAN
9780873898690
Afmetingen
254 x 184 x 32 mm
Bindwijze
Hardback

U ontvangt bij ons altijd de laatste druk!


Rubrieken

Boekstra