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

Book

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

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

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

Regulations, Standards, and Guidelines

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

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

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

Regulations, Standards, and Guidelines
ByLeonard Steinborn
Edition 6th Edition
First Published 2004
eBook Published 30 December 2004
Pub. Location Boca Raton
Imprint CRC Press
DOI https://doi.org/10.3109/9780203026656
Pages 452
eBook ISBN 9780429216374
Subjects Bioscience, Engineering & Technology
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Steinborn, L. (2004). GMP/ISO Quality Audit Manual for Healthcare Manufacturers and Their Suppliers, (Volume 2 - Regulations, Standards, and Guidelines): Regulations, Standards, and Guidelines (6th ed.). CRC Press. https://doi.org/10.3109/9780203026656

ABSTRACT

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 1Easy-to-read and organized to provide fa

TABLE OF CONTENTS

chapter |8 pages

Part II Electronic Records/Electronic Signatures

chapter |3 pages

Part 803 Medical Device Reporting

chapter |3 pages

Part 806 Medical Devices; Reports of Corrections and Removals

chapter |3 pages

The European Community (EC) Guide to Good Manufacturing Practices for Medicinal Products, including Annexes 1 and

chapter |20 pages

Part 820 Quality System Regulation

chapter |29 pages

Part 211 Current Good Manufacturing Practice for Finished Pharamaceuticals

chapter |45 pages

Guidance for Industry* Q7A Giid Manufacturing Practice Guidance for Active Pharmaceutical Ingredients

chapter |105 pages

Part 1301 Registration of Manufacturers, Distributors and Dispensers of Controlled Substances

chapter |14 pages

Military Specification

chapter |20 pages

Standard Practice for Established Reliability and High Reliability Qualified Products List (QPL) Systems For Electrical, Electronic, and Other Optic Parts Specifications

chapter |60 pages

The Rules Governing Medicinal Products in the European Union

chapter |41 pages

Quality Managemnet and Quality Assurance Standards—Part 3

chapter |18 pages

Quality Systems—Models for Quality Assurance in Design, Development, Production, Installation and Servicing

chapter |32 pages

Quality Management Systems—Requirements

chapter |13 pages

Quality Systems—Medical Devices—Particular Requirements for the Application of ISO 9001

chapter |12 pages

Quality Systems—Medical Devices Particular Requirements for the Application of ISO 9002

chapter |35 pages

International Standard ISO/IEC 17025 General Requirements for the Competence of Testing and Calibration Laboratories

chapter |37 pages

International Standard ISO 19011* Guidelines for Quality And/Or Environmental Management Systems Auditing

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