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 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To expedite release of recall information the FDA published a draft guidance to ensure better, more timely information reaches consumers.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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Feb 15

Revised USP Chapter for Elastomeric Closures now official ...

End of December the USP published its revised chapter <381> Elastomeric Closures for Injections which became official on January 1, 2018.

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Feb 15

Specifications and Acceptance Criteria for Impurities: new FDA Principles! ...

The FDA's Office of Pharmaceutical Quality has published a new MAPP document (Manual of Policies and Procedures) on acceptance criteria and specifications for impurities. In provides principles on the determination of specifications and acceptance criteria for non-mutagenic impurities in authorisation applications, based on clinical relevance. Read more about the Office of Pharmaceutical Quality's new FDA document.

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Feb 14

Quality Risk Management: What Inspectors are looking for ...

ICH Q9 is the major guideline providing principles and examples of tools for Quality Risk Management (QRM). But how do competent authorities look at these systems in their GMP inspections?

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Feb 07

Effect of the new Annex 13 on Complaints and Recalls ...

The final "Detailed Commission guidelines on GMP for IMPs for human use" have been published in Annex 13 of the EU GMP-Guidelines. What has changed in comparison to the previous Annex 13 in regard to complaints and recalls?

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