Steinborn GMP/ISO Quality Audit Manual for Healthcare Manufacturers and Their Suppliers, (Volume 2 - Regulations, Standards, and Guidelines)

Regulations, Standards, and Guidelines
6. Auflage 2004
ISBN: 978-0-203-02665-6
Verlag: Taylor & Francis
Format: PDF
Kopierschutz: Adobe DRM (»Systemvoraussetzungen)

E-Book, Englisch, 452 Seiten

This well-known QA manual has been updated to provide the guidance readers need to assess their compliance with standard regulations. This Volume 2 of a three-part package contains the full text on:

* FDA regulations
* EC and IPEC guidelines
* ISO/BSI standards referenced in the checklists furnished in volume 1

Easy-to-read and organized to provide fast access to guidelines and regulations, this is an essential reference for those working in the field.

Autoren/Hrsg.

Steinborn, Leonard

Fachgebiete

• Technische Wissenschaften Verfahrenstechnik | Chemieingenieurwesen | Biotechnologie Pharmazeutische Technologie
• Wirtschaftswissenschaften Wirtschaftssektoren & Branchen Fertigungsindustrie Pharmaindustrie

Inhaltsverzeichnis

The world's most widely recognized QA manual has been updated to provide guidance readers need to assess their compliance with standards and regulations. Volume 2 of this three-part package contains the full text of the
FDA regulations, EC and IPEC guidelines, and ISO/BSI standards referenced in the checklists furnished inVolume I.