GMP/ISO Audit Manual for Healthcare Manufacturers
and Their Suppliers

Sixth Edition • 2 Volume Set • by Leonard Steinborn

Features:

• Standardizes audits and minimize subjectivity amongst auditors

• Provides easy, objective, and quantifiable results for management track and trend compliance

• Assures comprehensive auditing of all facets of applicable regulations and standards

• Enables auditors to easily trace checklist questions to the requirements in preparation for closing meetings

Are you compliance ready for 2003 and beyond? Have you audited against the following new standards and regulations?

• US CFR PART 11 Electronic Records and Signatures
• ISO 9001-2000 Quality Management Systems Requirements (replacement for ISO 9001, 9002 & 9003 -1994)
• ISO 13485/13488 Quality Systems - Medical Devices (replacements for EN46001 and EN46002)
• ISO 17025 General Requirements For The Competency Of Testing and Calibration Laboratories (replacement for EN 45001)

And is your organization prepared for the latest US FDA inspection approach?

• QSIT - Quality System Inspection Technique

If you are unsure, help is here—the Sixth Edition of the GMP/ISO Quality Audit Manual for Healthcare Manufacturers and Their Suppliers. The world's most widely recognized QA manual has been updated to provide the audit system you need to assess compliance with these new standards/regulations and those that continue in effect.

Additionally, the acclaimed author provides a checklist that simulates FDA QSIT audits. This new edition continues a two decade tradition of widely recognized and used guidance for performing effective audits. Comprehensive in its coverage, this practical guide is an invaluable tool that offers effective training for new auditors and updates current auditors on new standards and regulations. It helps defuse FDA inspectors frustration in not being able to view audit reports. When combined with a procedure, the checklists demonstrate that comprehensive auditing is part of the quality system.

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 1.

The Software Package consists of the checklists in electronic format that permits users to:

• Load them onto computers and use as is
• Modify them by adding users' own questions
• Complete the checklists and store as an electronic record
• Print all checklists

Computer requirements: Windows 95, 98, or NT. The software can be installed on laptops, single-user stations, or a network (but is enabled for only one user at a time).

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