GMP/ISO Quality Audit Manual for Healthcare Manufacturers and Their Suppliers, (Volume 1 - with Checklists and Software Package) : With Checklists and Software Package

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GMP/ISO Quality Audit Manual for Healthcare Manufacturers and Their Suppliers, (Volume 1 - with Checklists and Software Package) : With Checklists and Software Package

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  • 製本 Hardcover:ハードカバー版／ページ数 448 p.
  • 言語 ENG
  • 商品コード 9780849318467
  • DDC分類 338.47610280685

Full Description

Volume 1 of this two-part package provides a complete set of checklists for internal and contract device and drug manufacturers and developers, contract software developers, and suppliers of chemical, printed material, electronic component, and general supplies. It also includes a simulated QSIT audit, and a new-product market launch. All of these are referenced to the relevant relevant FDA regulations, EC and IPEC guidelines, and ISO/BSI standards. The text also explains various audit types, do's and don'ts for auditors, and guidance for audit preparation, performance, conclusion, report derivation, and follow up activities. A CD-ROM packaged with the book contains all of the checklists in a customizable electronic format.

Contents

VOLUME 1 includes checklists for: Internal Device Manufacturer/Developer, Internal Drug Manufacturer/Developer, Contract Device Manufacturer/Developer, Contract Drug Manufacturer/Developer, Contract Software Developer, General Supplier, Chemical Supplier, Printed Material Supplier, Electronic Component Supplier, Simulated QSIT Audit (FDA Approach), and New Product Market Launch - all referenced to the relevant FDA regs, EC and IPEC guidelines, and ISO/BSI standards. It also includes complete explanation of audit types, their advantages/disadvantages, do's and don'ts for auditors and guidance for audit preparation, performance, conclusion, report derivation and follow up activities. VOLUME 2 contains full texts of the regulations, standards, and guidelines referenced in Volume I.