EU GMP Annex 1 released

The EU Commission has published their long-awaited revision draft of Annex 1 "Manufacture of Sterile Medicinal Products".

About The Annex 1 Conference

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

Jan 17

New Annex 1: Consequences for the QP ...

The new  draft of Annex 1 (Manufacture of Sterile Medicinal Products) will be much more extensive and contain some new rules and additions. There are also some things in the Annex 1 draft QPs need to consider.

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Jan 17

EMA revises Post-Authorization procedural Advice ...

The European Medicines Agency (EMA) recently revised its post-authorization procedural advice for users of the centralized procedure.

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Jan 17

What Will Change with the New GMP Guideline? ...

The GMP guideline is dead - long live the GMP guideline. It was with this phrase that new kings were announced in France in order to demonstrate the monarchy's continuity. But what about content consistency between the old and the new guideline? What are the differences between both GMP guidelines? What will change in the new GMP Guideline, what will stay the same?

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Jan 17

Ph. Eur. Monograph on Rubber Closures revised ...

The revised Ph. Eur. Monograph 3.2.9. on rubber closures will become official on July 1, 2018 (Supplement 9.5). Read more about Rubber closures for containers for aqueous parenteral preparations, for powders and for freeze-dried powders.

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Jan 10

Switzerland: important Amendments to the MRA ...

Chapter 15, which is relevant for medicinal products, has been supplemented by further details on the promotion of collaboration between the individual supervisory agencies and inspectorates. Companies will be better informed now, as well.

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Jan 10

Effects of the Annex 1 draft on 100% inspection of Parenterals ...

After many postponements, the long awaited Annex 1 draft of the EU GMP Guideline has finally been published on 20 December, 2017. While the chapters on integrity testing and visual inspection of injectables used to be rather short, the draft now contains several updates.

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