PHARMACY
eip26-sep15
eip26-sep15
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A unique and comprehensive guide to ensure<br />
regulatory compliance and success in<br />
pharmaceutical regulatory<br />
inspections<br />
Edited by Madhu Raju Saghee<br />
Quality Assurance, Micro Labs,<br />
and Director of PHSS, India<br />
Foreword by Peter D. Smith<br />
Vice President, Strategic Compliance,<br />
PAREXEL Consulting, USA<br />
PHARMACEUTICAL<br />
REGULATORY<br />
INSPECTIONS<br />
“EVERY INSPECTION A SUCCESS STORY –<br />
A PRACTICAL GUIDE TO MAKE IT HAPPEN"<br />
In over 500 pages and twelve chapters this<br />
unique book provides a focussed account of<br />
regulatory issues from pre-approval<br />
inspections and the inspection itself to postinspection<br />
and maintaining compliance. This is<br />
a book that every pharmaceutical company will<br />
wish to study before and during any inspection<br />
process to ensure a successful outcome.<br />
Complete Remit<br />
The book is a fully detailed and practical guide<br />
containing advice and insight to help any<br />
pharmaceutical organisation prepare for GMP<br />
Inspections, understand key regulatory issues<br />
and review inspectorate trends and findings.<br />
Expert Advice<br />
The authors, with a wealth of regulatory<br />
experience behind them, express their views<br />
and provide useful and practical tips for<br />
succeeding in vital regulatory inspections<br />
EDITED BY MADHU RAJU SAGHEE<br />
International Applications<br />
The book includes chapters covering FDA<br />
Inspections, EU Inspections, Japanese<br />
Inspection and International Inspection<br />
processes.<br />
Foreword<br />
– Peter D. Smith<br />
Preface<br />
–Madhu Raju Saghee<br />
1 Basic Concepts of Global GMP<br />
Requirements<br />
by Tim Sandle and Madhu Raju<br />
Saghee<br />
2 FDA Drug Regulation and<br />
Enforcement<br />
by Seth Mailhot<br />
3 System Based Approach to<br />
Inspections<br />
by David Barr and Tim Sandle<br />
4 Preparing for Preapproval<br />
Inspections<br />
by Ron Johnson<br />
5 Effectively Managing and Surviving<br />
FDA Inspections<br />
by John Avellanet<br />
6 Guide for Successful EU<br />
Inspection Management<br />
by Siegfried Schmitt and Nabila Nazir<br />
7 Regulatory Requirements of<br />
Japanese GMP Inspections<br />
by Yoshikazu Hayashi<br />
8 Preparing and Management of<br />
International Inspections<br />
by Andreas Brutsche and Tim Sandle<br />
9 Handling and Responding to Post<br />
Inspectional Observations<br />
by Tim Sandle, Madhu Raju Saghee<br />
and David Barr<br />
10 Preparing for Regulatory<br />
Inspections of Sterile Facilities:<br />
The Focal Points<br />
by Tim Sandle<br />
11 Preparing for Regulatory<br />
Inspections of API Facilities: The<br />
Focal Points<br />
by Siegfried Schmitt and Richard<br />
Einig<br />
12 Optimizing your Regulatory<br />
Compliance<br />
by Mark Tucker<br />
order online at www.euromedcommunications.com<br />
Or contact the publishers: email: publisher@euromedcommunications.com;<br />
Tel: +44 (0)1428 752222; Fax: +44 (0)1428 752223.
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