European Conference on APIs

Europe's leading event on active pharmaceutical ingredients takes place on 24-26 October, 2018 in Budapest, Hungary.

Particles in Parenterals

Main topic of this conference is the detection of particles in injectables and their evaluation during batch release and continuous process improvement. It takes place on 10-11 October, 2018 in Hamburg, Germany.

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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.

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.

Latest GMP News

Sep 18

FDA´s draft Guidance on Post-approval Changes to APIs ...

API manufacturers who want to make changes to the API manufacturing process during an application's post-approval period should read FDA´s new draft guidance for industry: Postapproval Changes to Drug Substances.

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Sep 18

What to expect from GVP inspections? ...

The MHRA recently updated their Good Pharmacovigilance Practice (GVP) webpage on the MHRA website. In addition, the agency provided important things to know about GVP inspectors and GVP inspections.

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Sep 18

CMDh Clarifications on the Implementation of the Falsified Medicines Directive ...

In April 2018, the CMDh published a document to clarify questions which arose from the original Q&A document dated March 2017 on the implementation of the Falsified Medicines Directive. Read more about the document "CMDh clarifications on questions received on the implementation of the Falsified Medicines Directive".

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Sep 18

Pharmacovigilance: Be prepared for "Hard Brexit" ...

The UK Government has released some information regarding the consequences of the Brexit on pharmacovigilance and the establishment of the Qualified Person for Pharmacovigilance (QPPV).

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Sep 12

New Questions and Answers on Safety Features - EU Q&As Version 10 published! ...

The safety features required for the implementation of the Anti-Counterfeit Directive will have to be implemented by the 9th February 2019. The European Commission released version 10 of the questions and answers catalogue on safety features in July 2018. Get more details about the revised Q&A document of the EU on safety features.

More New Questions and Answers on Safety Features - EU Q&As Version 10 published!

Sep 12

What are FDA's Expectations from Contract Manufacturers? ...

In a four-page Warning Letter to a contract manufacturer who produces semi-solid OTC products, the FDA criticizes amongst others the missing tests of starting and finished products.

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Upcoming Conferences and Courses

Hamburg, Germany
18-19 September 2018

Complaint Handling and Recall Management

Prague, Czech Republic
20-21 September 2018

Plastic Packaging Materials - Development, Manufacture, Use and Control

USP Headquarters, Rockville, Maryland
September 24-25, 2018

USP Workshop Promotion for Enhanced Approaches for Analytical Procedure Lifecycle, September 24-25, 2018 co-sponsored by ECA (no member rates will apply)

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Efficient Supplier Qualification & Pre-course Session: What you need to know about suppliers in China and India

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Hamburg, Germany

27-29 March 2019

Efficient Supplier Qualification & Pre-course Session: What you need to know about suppliers in China and India

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European Conference on APIs

Particles in Parenterals

Acknowledged GMP/GDP Certification

GMP/GDP Training Matrix

ECA WebAPP – standing out, outstanding

Latest GMP News

FDA´s draft Guidance on Post-approval Changes to APIs ...

What to expect from GVP inspections? ...

CMDh Clarifications on the Implementation of the Falsified Medicines Directive ...

Pharmacovigilance: Be prepared for "Hard Brexit" ...

New Questions and Answers on Safety Features - EU Q&As Version 10 published! ...

What are FDA's Expectations from Contract Manufacturers? ...

Upcoming Conferences and Courses

Complaint Handling and Recall Management

Plastic Packaging Materials - Development, Manufacture, Use and Control

USP Workshop Promotion for Enhanced Approaches for Analytical Procedure Lifecycle, September 24-25, 2018 co-sponsored by ECA (no member rates will apply)

GMP Newsletter

Recommended Event

Efficient Supplier Qualification & Pre-course Session: What you need to know about suppliers in China and India

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What do the Guidelines say?

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What do the
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