ECA – Your GMP/GDP Information Source

With news, trainings and conferences, a comprehensive guidelines database, publications and more the ECA is the leading European training and information services provider in the GMP and GDP environment.

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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

Nov 21

And the EMA goes to ... Amsterdam ...

When Britain leaves the EU, the European Medicines Agency (EMA) will have to move as well. The final decision where to was made by drawing the name of the new EMA location out of a hat. How could that happen?

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Nov 16

EudraVigilance: EMA's new Signal Management Guide ...

In line with the go-live date of the new EudraVigilance database EMA now published the revised GVP module IX on signal management. The revised module IX will introduce major procedural changes for industry.

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Nov 16

USA: Track & Trace Realisation Postponed by a Year ...

In June, the FDA reported that the enforcement of requirements for the safety of supply chains will be postponed by a year. The new date is now November 27, 2018. Find out more about the change of the date in the FD&C Act.

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Nov 16

FDA's new Guidances on the Approval of Generic Drugs ...

The FDA has recently published various guidelines on application procedures for generics. Read here, which special requirements have to be met for the authorisation application of generics for the US market.

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Nov 15

Will FDA now stop conducting GMP inspections? ...

The European Medicines Agency (EMA) has updated its Q&A section on the Mutual Recognition Agreement. These questions mainly refer to the start of the operating phase of the MRA on 1 November 2017.

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Nov 15

Insufficient Media Fills in FDA Warning Letter ...

Insufficiently planned and performed media fills were at the centre of an FDA Warning Letter. Read more about the criticised deficiencies from a Warning Letter to the Korean manufacturer Firson Co., Ltd.

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