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

Feb 20

FDA Draft Guideline on reporting Changes to an approved Application ...

At the end of last year, the FDA published a revision draft for their guideline "Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products" which is supposed to take account of the current standards of risk assessment and the submitted data of past change notifications.

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Feb 20

FDA publishes Questions and Answers on Pathogen Reduction in Blood Components ...

With their new questions and answers paper, the FDA wants to provide further information on the implementation of pathogen reduction techniques for blood establishments.

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Feb 20

FDA revises Guideline on HIV and HCV Testing for the Assessment of Blood Donors ...

With an update of their guideline on NAT testing of blood and plasma donations for HIV-1 and HCV, the FDA takes account of the developments regarding methods and related regulations.

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Feb 20

FDA publishes Draft Guideline on Use of Nanotechnologies for Biological Medicina ...

The FDA expands their guidelines regarding the use of nanotechnologies with a draft on the topic "Drug Products, Including Biological Products, that Contain Nanomaterials".

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Feb 15

Alarms and Delay Times from a GMP Viewpoint ...

Up-to-date monitoring systems produce vast amounts of data, e.g. pressure, humidity and temperature in clean rooms. In pharmaceutical production practice, there are different approaches to handle this electronic data - alarms especially. Not all of them are ideal from a GMP viewpoint.

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Feb 15

FDA strengthens Public Warning and Notification of Recalls ...

To expedite release of recall information the FDA published a draft guidance to ensure better, more timely information reaches consumers. Read more about FDA’s policy on public warning and notification of recalls.

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