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No. 5 - Quality Management System
September 2009
       
Contents

Dear Colleagues,

GMPs are constantly changing and sometimes it is interesting to see it from a new perspective.  ISO is used in a lot of industry areas and we think the article below could also be interesting for you.

I am getting ready for my next US trip and you can meet me at the PDA/FDA Joint Conference in Washington. Did you know that the GMP MANUAL is featured as a recommended reading for this event?

NEW! During the summer our team has been working hard to make our new website as user friendly as possible. Read below about  the new features, or check out the excerpt of the GMP MANUAL.

With kind regards,

Thomas Peither
President
       

ISO 9001:2008 Quality Management System

This article compares the old standard ISO 9001:2000 with the latest edition ISO 9001:2008, which has acquired the status of a global benchmark for quality requirements and customer satisfaction in supplier-customer relationships.

Click here to read the lead article:

This article is an excerpt of the quarterly published gmp review which is published by our partner Euromed Communications.



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www.gmp-publishing.com

 

New Maas & Peither Website

Since July 2009 the new website of Maas & Peither - GMP Publishing is online.

With new features which help you to keep current :

  • News page: Here you can find news from the GMP community such as publication of new regulations, warning letters, initiatives or news about companies, developments, events, etc.
  • RSS feed: You can read our news by using RSS feed. This way you will see the news directly in your browser.
  • Web shop: Here you can buy directly through a secure shopping system with your credit card and we will ship your order within 24 hours after online payment
  • Links: We provide one of the most comprehensive GMP link lists in the internet. Have a look and check all the international regulators and industry sources from here.
  • GMP MANUAL: You can access the most powerful GMP knowledge base through this new website.

And you can find so much more on this website... Have fun browsing!

We appreciate comments, suggestions for improvement, etc. to our new online profile.We intend to deliver you the best GMP information around the globe.

New website Maas & Peither



PDA-FDA-Logo

PDA/FDA Joint Regulatory
Conference Brochure

GMP MANUAL featured as Recommended Reading

Come and meet our President Thomas Peither in Washington at the PDA/FDA Joint Regulatory Conference in Washington, D.C. (September 14-15) at  booth No. 34. Max Lazar will also available at the booth and meet authors and more advisory board members.

The PDA/FDA Joint Regulatory Conference offers the unique opportunity for you to join FDA representatives and industry experts in face-to-face dialogues. Each year, FDA speakers provide updates on the current state of efforts impacting the development of global regulatory strategies; while industry professionals from some of today’s leading pharmaceutical companies present case studies on how they employ global strategies in their daily processes.

Come, see and win a prize of the raffle which is also sponsored by Maas & Peither.

For more information go to: PDA/FDA Joint Regulatory Conference

The GMP MANUAL is listed by the PDA for this conference as: Recommended Reading



Manual50
GMP MANUAL
- Hardcopy
- CD-ROM
- Online

In-Process-Control (Reading Sample)

In this excerpt of the Chapter Production you will find answers to the following questions:

  • What are the in-process control tasks?
  • Where should the in-process control group be established in organisational and disciplinary terms?
  • How are the responsibilities regulated?
  • How are in-process controls carried out?

Click here for an actual reading sample of the GMP MANUAL

Update 7 for the GMP MANUAL will become available by the end of September 2009.
Please check out the latest table of contents here:

Link to GMP MANUAL table of contents



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NEW EDITION: Manufacturing

We are proud to announce that the book MANUFACTURING will be available shortly.

This is an excerpt from the comprehensive reference work GMP MANUAL. It is intended to support staff in the pharmaceutical production field by providing internationally accepted GMP guidance. In this book, international GMP experts share their knowledge of GMP implementation according to GMP regulations of the FDA, Europe, ICH, PIC/S and WHO. You’ll learn how noted industry specialists solve the quality challenges in their companies, and improve and fine-tune your procedures accordingly. You will receive answers to quality related questions that affect your daily business.

620 pages, € 175 / US$ 250

More information: Volume 1 Manufacturing



Latest GMP news

What else is happening around the world?

Just click on the link:

find more news at: NEWS



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