Establishing a CGMP laboratory audit system
Subtitle: a practical guide
By: David M. Bliesner.
Publisher: Wiley-Interscience
Published: 2006
Place of publication: Hoboken, N.J
Language: eng
Subjects: Pharmaceutical industry -- Law and legislation -- United States.; Drug Industry -- standards -- United States.; Laboratories -- standards -- United States.; Management Audit -- methods -- United States.; Drug Industry -- legislation & jurisprudence -- United States.; Laboratories -- legislation & jurisprudence -- United States.
Notes: Includes bibliographical references and index.
Table of contents: title: Preface; title: Introduction to the quality systems approach to CGMP compliance; title: Preparing for the audit; title: Auditing and data capture; title: Organizing data and reporting the results; title: Developing and implementing a corrective action plan; title: Developing and implementing a verification plan; title: Developing and implementing a monitoring plan; title: Summary; title: Appendixes; title: Example audit checklists: laboratory sub elements; title: Audit summary report example-template; title: Glossary of CGMP and audit system terms; title: Food and drug administration compliance program: guidance manual 7356.002 "drug manufacturing inspections"; title: 21 Code of Federal Regulations parts 210 and 211: 487 current good manufacturing practice regulations.