CAPA in the pharmaceutical and biotech industries: how to implement an effective nine step program

by Rodríguez, J.

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Title Statements

Full title :CAPA in the pharmaceutical and biotech industries : how to implement an effective nine step program / by J. Rodriguez.

Edition Statements

Publication Date:2015.

Publication Statements

Publisher(s):Woodhead Publishing
Place of Publication:Oxford
Language:eng
Publication Date:2015.

Notes

Previously issued in print: Witney: Biohealthcare, 2011.

The Physical Object

Description:1 online resource.

Edition Identifiers

ISBN:9781908818379, 1908818379
oclc:ocn935679448
LC Classification:RS189
Dewey Decimal:615.1900685

Front Cover; Related titles; CAPA in the Pharmaceutical and Biotech Industries; Copyright; Dedication; Contents; Biography; Preface; Introduction; Corrective and preventive action (CAPA); What is an appropriate CAPA program?; Analyze data for trends; Preventive actions; 1 -- Understanding the FDA's CAPA requirements and regulations; Part I. 21 CFR part 820.100 for medical devices; Part II. 21 CFR Part 211: current good manufacturing practice for finished pharmaceuticals; Part III. The FDA's current inspectional approaches; Review of the quality system inspectional technique: medical devices.

QSIT and CAPAWhat is QSIT?; Part IV. QSIT and CAPA: inspectional objectives; Purpose/importance; Part V. Quality systems approach to pharmaceutical current good manufacturing practice regulation, September 2006; Background; In August 2002, the FDA announced the Pharmaceutical CGMPs for the Twenty-First Century Initiative; CGMPs and the concepts of modern quality systems; Review of the concept of corrective action; Preventive actions; Promote improvement; Part VI. ISO 13485 and CAPA: inspectional objectives; Measurement, analysis, and improvement; General; Monitoring and measurement.

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