ECA – Your GMP/GDP Information Source

With news, trainings and conferences, a comprehensive guidelines database, publications and more the ECA is the leading European training and information services provider in the GMP and GDP environment.

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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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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

Jun 28

Being inspected by ANVISA? Or COFEPRIS? ...

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

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Jun 28

How often do HEPA Filters have to be changed? ...

In the pharmaceutical industry, HEPA filters are used as terminal filters for the processing or filtration of air in production spaces. They are mandatory in sterile production, although they are somtimes also used in the manufacture of solid or semisolid dosage forms. Amongst the HEPA or high-efficiency particulate filters are Filter Classes H13 to H14 (DIN 1822), the latter with a retention rate of 99.995%. But how often do HEPA filters need to be changed?

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Jun 26

Visual Inspection Board finishes work on Container-/Closure-Integrity Document ...

Members of the ECA Visual Inspection Board have finished their work on a position paper regarding Container-/Closure-Integrity testing. The new document is now available in the download section of the ECA Visual Inspection website.

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Jun 21

Elemental Impurities - Binding Risk Assessment for Authorised Medicinal Products ...

EMA's document on the implementation of ICH Q3D for already marketed products contains essential recommendations for marketing authorisation holders. Learn why risk assessments with regard to elemental impurities for existing marketed products are so important and how to decide about the necessity of a variation procedure.

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Jun 21

Maintenance Cycles of pharmaceutical Water Systems ...

To maintain the qualified state of a pharmaceutical water system, a reliable maintenance plan is necessary. This is an official requirement, though it does also make sense from an operational viewpoint. Maintenance intervals based on the criticality of individual components are usually defined during qualification. But what is the rule here?

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Jun 21

Swissmedic specifies Requirements for RPs ...

The current edition of the Swissmedic Journal 05/2017 and the Technical Interpretation I-SMI.TI.17 specify the requirements with regard to the independence and the obligation of presence of the Swiss QP.

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