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Outsourcing Qualification

No. 17/2012 - May 2012

Outsourcing Qualification - API EU Import Template - Special Offer CSV

Dear Colleagues,

GMP compliant qualification of technical systems is still a critical issue in the sector. In early days of GMP qualification was performed by the pharmaceutical companies itself. Today - this task is outsourced! But what critical topics are there to think about when you award a contract? Read our feature today to learn more about it.

The European Commission published a draft template for API imports to Europe. If you want to comment this paper you have time until June 1, 2012 (see our GMP News).

Thomas Peither

PS: Take the chance to save €30/$40 for "Computer Systems Validation" today!



Outsourcing qualification activities to suppliers

What should an all-inclusive qualification package include?

What is the content of a contractor agreement?

What are the obligations of the contract giver and the contract acceptor?

Learn about the following topics in the feature today:

  • Reconciliation of definitions and contents
  • Definition of the scope of qualification
  • Adaptation of the contract giver's qualification strategy
  • Processing times for approving documents
  • Use of subcontractors
  • Certificates
  • Handling of raw data
  • Handling of changes and deviations

>>> Click here to read the feature "Transfer of qualification activities to suppliers" by Ulrike Reuter, Sanofi (Germany), Max Lazar, Consultant, (USA)

You know that you can save time and money every day if you use the GMP MANUAL in your daily business. Learn more about the GMP MANUAL...


Last chance: Promotion Price valid until Friday

The promotion price for our new GMP Subject Download "Computer System Validation" is only valid until Friday.

Take the chance and save more than 20% now!

Your benefits:

  • time-limited offer: 99.00 €*/149.00 US$* promotion price until May 25, 2012, then 129.00 €*/195.00 US$*.
    * plus tax if applicable
  • no shipping costs
  • no waiting period: if you choose payment by credit card you will receive an email with the download information immediately after payment.

>>> Click here to buy the GMP Subject Download "Computer System Validation"


GMP News: API Import Template

EC: API Import Template (Draft)

The European Commission has published a draft template"Written confirmation for active substances imported into the European Union (EU) for medicinal products for human use" in accordance with article 46b(2)(b) of Directive 2001/83/EC1, for public consultation.



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