The ICH Q12 Conference

From 13-14 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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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

Jul 18

USP chapter on packaging and storage revised ...

New suggestions by the USP on chapter <659> have been published in the Pharmacopeial Forum (PF) 44 (4). It addresses plastic packaging as well as the regulations and requirements for child-resistant packaging. Read more about chapter <659> - Packaging and Storage Requirements in this article.

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Jul 18

Revised FDA Guidance on the validation of analytical methods ...

After five years and thorough revision, the FDA Guidance "Bioanalytical Method Validation" has been finalised. Read here what requirements the FDA lays down for a completely validated bioanalytical procedure.

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Jul 18

Post-Approval Change Management - Does ICH Q12 offer a solution? ...

ICH Q12, currently in draft form for public consultation, provides an opportunity to save time and money associated with regulatory submissions. Read more about "new" lifecycle tools and enablers for global post-approval change management provided in the proposed guideline on "Life Cycle Management".

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Jul 18

21st Edition of the GMP Matrix Published ...

Published in its 21st edition by now, the GMP Matrix has been a recognised standard for GMP auditors or QA units since 2005, and not only in multinational companies. The Matrix juxtaposes the US cGMP requirements as per CFR 210/211 with the EU GMP Guidelines. What has changed in recent years in particular?

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Jul 18

Being inspected by ANVISA? ...

Quite a few supervising authorities in the health care sector come for GMP inspections also to foreign countries. Read what the Brazilian ANVISA and the Mexican COFEPRIS will expect.

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Jul 11

Two FDA warning letters to manufacturers of creams ...

The US Food and Drug Administration (FDA) recently issued  two warning letters to a contract manufacturers based in Australia and a Korea-based drugmaker.

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Upcoming Conferences and Courses

After the MRA: Understand European GMPs and the Role of the Qualified Person (QP)

Chicago, Il, USA
August 28-29, 2018

After the MRA: Understand European GMPs and the Role of the Qualified Person (QP)
Audit Trail Review

Copenhagen, Denmark
28 August 2018

Audit Trail Review
Data Integrity - Requirements for a GMP-compliant Data Life Cycle & full-day pre-course session Audit Trail Review

Copenhagen, Denmark
28-31 August 2018

Data Integrity - Requirements for a GMP-compliant Data Life Cycle & full-day pre-course session Audit Trail Review
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ICH Q7 How to do – Hot Topics from the revised APIC guidancerevisions<br>Pre-conference session to the 21st APIC/CEFIC European Conference

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Budapest, Hungary

23 October 2018

ICH Q7 How to do – Hot Topics from the revised APIC guidancerevisions Pre-conference session to the 21st APIC/CEFIC European Conference

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