The ICH Q12 Conference

From 14-15 November 2018 in Berlin: The ICH Steering Committe published the new ICH Q12 Guideline on "Product Life Cycle Management" only recently. Learn from industry experts, authority speakers and 3 Members of the ICH Q12 Expert Working Group about the new guideline.

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European GMPs and the Role of the QP

Understand the European approach and the legal framework – and get familiar with the unique roles and responsibilities of the EU QP.

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Acknowledged GMP/GDP Certification

Highly qualified personnel is crucial in the pharmaceutical industry. The ECA Certification scheme with 14 continuous education programmes trains you adequately.

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GMP/GDP Training Matrix

GMP/GDP Training Matrix

Are you looking for certain GMP/GDP Training Courses? The GMP/GDP Matrix will help you find your training course.

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ECA WebAPP – standing out, outstanding

The ECA WebApp lets you have all GMP/GDP information at hand – anytime, anywhere.

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Latest GMP News

May 23

Brexit: EMA still clear on Timelines ...

Despite the currently discussed "transition period", the European Medicines Agency (EMA) has emphasised that industry should be well prepared even for a so-called "hard Brexit.

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May 23

Must each container of a starting material be sampled for identification? ...

This question has been adopted by Health Canada in their "Good Manufacturing Practices (GMP) Questions and Answers". Read here, what recommendations the Canadian authority gives for sampling APIs and excipients.

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May 23

GMP for APIs practically applied - the revised APIC "How to do" guideline ...

The "How to do" document is one of APIC's many Best Practices Documents and has been upgraded to the current state of the art. Read here which practical recommendations in the implementation of GMP for APIs are included in the most recent version of the How-to-do document.

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May 23

Annex 1: the real Novelty ...

The revised Annex 1 to the EU-GMPs will bring a lot of new requirements. One of the major developments is the need for the implementation of a comprehensive Quality Risk Management System.

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May 23

Warning Letter due to cross contamination ...

In March 2018, the FDA has issued a Warning Letter to a manufacturer of medicinal products in the Dominican Republic due to various GMP violations. One of these violations was cross contamination.

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May 16

Quality Risk Management is getting more and more important ...

QRM is becoming more and more appreciated and implemented through guidance like the EU-GMP Guidelines and ICH Q8 - Q12. And Quality Risk Management is much more than merely FMEA.

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