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

ISBN-13: 9780849318474 / Angielski / Twarda / 2004 / 452 str.

Leonard Steinborn

Opis

Volume 2 of this set contains the full text of the FDA regulations, EC and IPEC guidelines, and ISO/BSI standards referenced in the checklists furnished in Volume I. The book is organized to provide fast access to the guidelines and regulations of interest.

Spis treści

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.

O autorze

Steinborn, Leonard