EU GMP Annex 1 Conference

Revision February 2020: New Requirements and Consequences for Industry.

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Weekly GMP Newsletter

The weekly Newsletter is now available here.

Read the GMP Newsletter dated 12.02.2020

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 – 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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Latest GMP News

Feb 25

GMP for Sterile Packaging Components ...

Will the revised Annex 1 provide guidance for the application of GMP to sterile primary packaging materials?

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Feb 25

How does the FDA deal with Non-Validable Processes? ...

In an interesting Warning Letter, the FDA replies to a letter from a pharmaceutical manufacturer that had received a 483 deficiency report in which the FDA criticized, among other things, deficiencies in process validation. Read more about the correspondence.

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Feb 25

Draft Annex 1: New Requirements for Lyophilization? ...

Will the revised Annex 1 introduce new GMP requirements for lyophilized products?

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Feb 20

Annex 1: European Commission Publishes Revised Document ...

On 20 February, the European Commission published the long-awaited revision of Annex 1 Sterile Manufacturing of the EU GMP Guideline. The document is now entering a timely limited commentary phase.

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Feb 19

CBD is controlled as a medicine in Finland ...

The Finnish Medicines Agency (Fimea) recently stated that Cannabidiol (CBD) is controlled as a medicine in Finland.

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Feb 19

Warning Letter: FDA criticizes Supplier Qualification ...

Supplier Qualification and the respective contracts in outsourcing activities are always hot topics in inspections, as a recent FDA Warning Letter shows.

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