MTU Library Catalogue

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Quality and GMP auditing. : clear and simple / James L. Vesper.

By: Vesper, James L.
Material type: materialTypeLabelBookPublisher: Boca Raton : CRC Press, 1997Description: xiii, 226 p. : ill. ; 24 cm. + hbk.ISBN: 1574910558.Subject(s): Pharmaceutical technology | Drugs -- Quality controlDDC classification: 615.10685
Contents:
What is a GMP or quality audit? -- The big picture -- Regulatory requirements and expectations for GMP audits -- Your auditing policy and SOP -- Types of audits -- Audit approaches -- Auditor qualifications and skills -- Phase I: preparation -- Phase II: conduct the audit -- Interviewing auditees -- Phase III: analyzing audit data -- Phase IV: the audit report -- Phase V: follow-up and closure -- Auditing vendors and contractors -- Being audited.
Holdings
Item type Current library Call number Copy number Status Barcode
General lending MTU Bishopstown Library Lending 615.10685 (Browse shelf(Opens below)) 1 Available 00099358
General lending MTU Bishopstown Library Lending 615.10685 (Browse shelf(Opens below)) 1 Available 00099357
Total holds: 0

Enhanced descriptions from Syndetics:

This guidebook provides proven methods and techniques for performing effective audits that serve your department, your company, and you. Topics covered relate to the four key competencies essential for successful GMP audits. Includes the rationale for auditing as an important quality tool, along with the audit cycle, broken into five distinct phases. To focus the power of auditing on a particular situation, several different types of audits are presented, as are more than a dozen audit approaches with general questions to answer and specific items to examine. These tools will help you prepare checklists and standards so audits become more effective, consistent, and standardized. The book includes profiles of seasoned professionals in drug and device auditing, who share their experiences (the good and the bad)!

Includes bibliographical references (pages 197-198) and index.

What is a GMP or quality audit? -- The big picture -- Regulatory requirements and expectations for GMP audits -- Your auditing policy and SOP -- Types of audits -- Audit approaches -- Auditor qualifications and skills -- Phase I: preparation -- Phase II: conduct the audit -- Interviewing auditees -- Phase III: analyzing audit data -- Phase IV: the audit report -- Phase V: follow-up and closure -- Auditing vendors and contractors -- Being audited.

CIT Module MGMT 6021 - Core reading

Table of contents provided by Syndetics

  • What Is a GMP or Quality Audit?
  • Big Picture
  • Regulatory Requirements & Expectations for GMP Audits
  • Your Auditing Policy & SOP
  • Types of Audits
  • Audit Approaches
  • Auditor Qualifications & Skills
  • Phase I Preparation
  • Phase II Conduct the Audit
  • Interviewing Auditees
  • Phase III Analyzing the Audit Data
  • Phase IV The Audit Report
  • Phase V Follow-up & Closure
  • Auditing Vendors & Contractors
  • Being Audited

Author notes provided by Syndetics

Vesper, James L.