http://www.loc.gov/mods/v3 http://www.loc.gov/standards/mods/v3/mods-3-2.xsd
Establishing a CGMP laboratory audit system
Preface -- Introduction to the quality systems approach to CGMP compliance -- Preparing for the audit -- Auditing and data capture -- Organizing data and reporting the results -- Developing and implementing a corrective action plan -- Developing and implementing a verification plan -- Developing and implementing a monitoring plan -- Summary -- Appendixes -- Example audit checklists: laboratory sub elements -- Audit summary report example-template -- Glossary of CGMP and audit system terms -- Food and drug administration compliance program: guidance manual 7356.002 "drug manufacturing inspections" -- 21 Code of Federal Regulations parts 210 and 211: 487 current good manufacturing practice regulations.
Electronic reproduction. Somerset, New Jersey : Wiley InterScience. Available via World Wide Web.
Includes bibliographical references and index.