PharmaLab Congress 2018

The Event for all pharmaceutical laboratory areas will take place on 20 and 21 November 2018 in Düsseldorf for the sixth time. The PharmaLab 2018 will cover various topics in 8 interesting conferences and lectures on analytics, bio analytics, microbiology and R&D.

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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

Nov 15

MHRA & FDA: First Joint Workshop on GCP in Washington ...

Data integrity plays an exceptional role in clinical studies. On 23-24 October, 2018, the US FDA and the British MHRA hosted a joint workshop on this topic. Learn more about the contents and results of the joint workshop "Good Clinical Practice: Data Integrity in Global Clinical Trials - Are we there yet?"

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Nov 15

Stability by Design - Guidelines for Assessing & Controlling Physical Stability ...

The USP Physical Stability Joint Subcommittee has published a Stimuli article regarding Guidelines For Assessing and Controlling the Physical Stability of Pharmaceutical Raw Materials, Intermediates, and Dosage Forms. 

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Nov 14

Valsartan: New Inspection reveals significant GMP Violations ...

An inspection by EU inspectorates in collaboration with EDQM has revealed significant GMP violations at a Valsartan manufacturer's site.

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Nov 14

USP article on pharmaceutical continuous manufacturing ...

In the latest edition of the Pharmacopoeial Forum 44(6), the US pharmacopoeia USP has published a so-called Stimuli Article on pharmaceutical continuous manufacturing. Apart from important definitions, the document contains further information on material properties and characteristics as well as risk management approaches for continuous manufacturing.

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Nov 08

Products with Genetically modified Cells - Draft Guideline ...

Due to the ongoing scientific development of laboratory methods, the EMA published a draft revision of their "Guideline on quality, non-clinical and clinical aspects of medicinal products containing genetically modified cells" for public consultation.

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Nov 08

False Positive HTLV Testing - Recommendations for Donor Requalification ...

In October 2018, the FDA published a new draft guidance with recommendations for a possible requalification of donors who had been deferred because of reactive test results for antibodies to Human T-Lymphotropic Virus Types I and II (anti-HTLV-I/II). Read more about the requalification method under 21 CFR 610.41.

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