Monday, 5 May 2014

Pharmaceutical Regulatory Inspections

‘Pharmaceutical Regulatory Inspections’ is a new book edited by Madhu Raju Saghee. The book contains practical advice and insight to help different types of pharmaceutical organisation prepare for GMP inspections. The book also provides an overview of current regulatory issues.

In over 600 pages and twelve chapters this unique book provides a focussed account of regulatory issues from pre-approval inspections and the inspection itself to postinspection and maintaining compliance. This is a book that every pharmaceutical company will wish to study before and during any inspection process to ensure a successful outcome.

The chapters are:
  • Basic concepts of global GMP requirements by Tim Sandle and Madhu Raju Saghee
  • FDA Drug Regulation and Enforcement by Seth Mailhot
  • System based approach to GMP inspections by David Barr and Tim Sandle
  • Preparing for preapproval inspections by Ron Johnson
  • Effectively managing and surviving FDA inspections by John Avellanet
  • Guide to successful EU inspection management by Siegfired Schmitt and Nabila Nazir
  • Regulatory requirements for Japanese GMP inspections by Yoshikazu Hayashi
  • Preparing and management of international inspections by Andreas Brutsche and Tim Sandle
  • Handling and responding to post inspectional observations by Tim Sandle, Madhu Raju Saghee and David Barr
  • Preparing for regulatory inspections of sterile facilities: the focal points by Tim Sandle
  • Preparing for regulatory inspections of API facilities: the focal points by Siegfried Schmitt and Richard Einig
  • Optimising tour regulatory compliance by Mark Tucker

For further details about this impressive and comprehensive book, see Euromed.

Posted by Tim Sandle