Annex 1 Conference

From 8-9 May 2018 in Berlin: Learn from 14 speakers among others from Hoffmann La Roche, Boehringer Ingelheim, Novartis and 4 GMP Inspectors about the new requirements published in the EU GMP Annex 1 revision.

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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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The ICH Q12 Conference

From 14-15 November 2018 in Berlin: The ICH Steering Committe published the new ICH Q12 Guideline on "Product Life Cycle Management" only recently. Learn from industry experts, authority speakers and 3 Members of the ICH Q12 Expert Working Group about the new guideline.

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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

Apr 18

Auditing Starting Materials - new APIC Guideline defines Standards ...

The use of starting materials in the production process for active pharmaceutical ingredients marks the starting point for GMP. But how can the quality of starting materials be ensured? Find out about what standards for auditing starting materials APIC has defined in their new guideline here.

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Apr 18

Again FDA emphasises Importance of written Contracts ...

The US Food & Drug Administration (FDA) has issued a Warning Letter to a US company recommending to have a look at FDA's Guidance on Contract Manufacturing Arrangements.

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Apr 18

Warning Letter due to falsified Data and poor Maintenance ...

The attempt to conceal hygiene deficiencies with inaccurate lab data resulted in a virtually inevitable Warning Letter after an FDA inspection. Read here, which violations of fundamental GMP rules for maintenance and cleaning of production equipment at an API facility were criticised by the inspectors.

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Apr 18

Ph. Eur. Packaging Chapters adopted ...

Several revised Ph. Eur. packaging chapters have been recently adopted by the Ph. Eur. Commission. These general chapters will appear in Ph. Eur. 9.6. Read more about the revised chapters on plasticized PVC materials and glass containers.

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Apr 17

The new Annex 1 and 5 µm Particles ...

In the current EU GMP Annex 1, the monitoring of 0.5 and 5 µm particles in clean rooms is a requirement. It refers to technical document ISO 14644, Part 1 for measurement. However, the limit for 5 µm for class ISO 5 (ISO 4.8) has been removed from this document. That is why there had been great expectations for the revised Annex 1 draft.

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Apr 17

FDA opens Docket on Continuous Manufacturing ...

In June 2017, the FDA opened a docket intended for public comments on the topic of continuous manufacturing. The FDA seems mainly interested in receiving comments on the C-SOPS document which was already published in 2016. This document contains recommendations of a group of U.S. university and industrial representatives regarding continuous production.

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