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Japanese Pharmaceuticals Inspection Guide

Published: December 2008 |  Pages: 120 |  Price:  $297  | ISBN:  978-1-60004-024-5
Japanese Pharmaceuticals Inspection Guide is your single source for Japanese GMP regulations and guidances — all translated into English and published by the PMDA — and the resource you need to make your next PMDA inspection successful.

Place your order today and get:

  • An overview of the GMP inspection process followed by Japanese inspectors
  • The five key systems that will be inspected by PMDA inspectors
  • Documents required to be submitted in advance of a PMDA inspection
  • Japanese regulations covering warehousing facilities
  • Procedures for issuing inspection reports and timelines for responding to PMDA findings

Inspections by Japanese regulators are on the rise, and they won’t wait for you to get ready. The government documents included in Japanese Pharmaceuticals Inspection Guide are:

  • The Ministerial Ordinance on Standards for Manufacturing Control and Quality Control for Drugs and Quasi-Drugs
  • Regulations for Buildings and Facilities of Pharmacies
  • The Explanation of Application for Accreditation of Foreign Manufacturers
  • GMP Compliance Inspection Concerning Pharmaceuticals (Including APIs)
  • Documents to Be Submitted for GMP Compliance Inspection
  • Overview Guidance of GMP Compliance Inspection for Foreign Manufacturers
  • Documents Required by PMDA for the Application of GMP Compliance
  • Inspection Outline of Drug Manufacturing Site (Foreign Manufacturing Site)
  • Guidance on Master File System
  • A Q&A on the Master File System

Buy Now!
Get ready for the PMDA’s visit with Japanese Pharmaceuticals Inspection Guide, priced at $297.

Interested in purchasing more than one print copy?
Significant volume discounts are available for ordering three or more copies of the same book. You must order them at the same time and provide a single payment to take advantage of the discount. Order below by clicking submit and then change your quantity in the shopping cart. The discount will be calculated automatically.

3-4 copies – 10%
5-6 copies – 15%
7-9 copies – 20%
10+ copies – 25%

Call (888) 838-5578 in the U.S. or +1 (703) 538-7600 globally with any questions.

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Print Version

PDF Version
ISBN: 978-1-60004-024-5 ISBN: 978-1-60004-025-2
PDF will be available to download after your purchase is complete.