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Top 10 GMP Deficiencies

No. 20/2012 - June 2012
       
Contents

Dear Colleagues,

the recent PDA-PIC/S event in Geneva was a great success. The Pharmaceutical Inspection Cooperation Scheme (PIC/S) is doing a great job in the field of GMP harmonization and made a survey with its members about the most critical deficiencies in the field of GMP.

We all know that we have to improve our quality systems in the pharmaceutical industry. Find out for yourself in today's feature what you have to look out for. Don't miss the chance to challenge your quality systems. Read also about the outcomes of the WHO World Pharmacopeias Meeting in our GMP news.

Regards,

Thomas Peither

       

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The Top 10 GMP Deficiencies of PIC/S Members

The feature gives an overview of the most critical deficiencies that have been reported by the PIC/S member authorities in an internal survey. The most severe deficiencies have been observed in the areas of

  • Production
  • Quality Systems
  • Premises and equipment

>>> Read more about the outcome of this PIC/S survey in our article "The Top 10 Deficiencies of PIC/S members".

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Site Master File according to PIC/S PE 008-4

Do you want to get an EU GMP certificate?

Then you need to have a Site Master File which is in compliance with the EU regulation framework. Make the preparatory work of your SMF easier and use our new e-book:

It contains a sample Site Master File (with a virtual company as an example) and useful comments on the separate sections.

For € 169.00* / US$ 255.00* you can download this convenient e-book.
*plus tax if applicable

>>> Order now: Site Master File - PDF Download

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GMP News: World Pharmacopoeias Meeting

2012-06-25
WHO: World Pharmacopoeias Meeting

For the first time in 10 years, representatives from pharmacopoeias from 23 countries came together on 29 February – 2 March 2012 at WHO headquarters in Geneva and committed to working further towards harmonization and strengthening WHO's role when developing global standards for the production and testing of medicines.

Read more...

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GMP In Practice - Regulatory Expectations

This book is a valuable source of references to the most important 33 elements of a pharmaceutical quality system. The book gives answers to the question:

"Where in the GMPs does it say I have to .......?"

The subtitle depicts the content: "Regulatory expectations for the pharmaceutical industry"

You will find specific references to the regulations of

  • the United States
  • Europe
  • the World Health Organisation (WHO)
  • the International Conference on Harmonisation (ICH)
  • Health Canada

>>> Order now: GMP In Practice

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