Press Announcements

How Equipment Suppliers can assist their Customers with Equipment Qualification

Equipment qualification is a mandatory requirement in the GMP area. So medicinal products/drugs and APIs are affected. In the past manufacturers of medicinal products/drugs and APIs did all qualification activities on their own. But more and more, equipment suppliers are being integrated into their customers' qualification system. How can this be successful?

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Update of the "ICH Q7 Side-by-Side Comparison" Booklet

The newly published booklet "ICH Q7 Side-by-Side Comparison" compares the requirements of the "ICH Q7 Guideline- GMP for Active Pharmaceutical Ingredients" to the interpretations of the revised "How to do"- Document - Interpretation of ICH Q7 Guide and "Review form" (Version 16) and explains the requirements of the guideline. 

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Annex 1 Final Version - EMA representative to present history and changes at December conference

In addition to the previously announced representatives of the GMP regulatory authorities, the industry and the expert groups, a representative of the EMA has now also confirmed his participation and will talk about the changes of the Annex1, their background and the perspective of the EMA.

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Annex 1-compliant Contamination Control

The new Annex 1 and the requirement for contamination control and an overarching strategy - what are the measures, how are they implemented and how is the concept of an overarching strategy to be understood?

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What does "GMP-compliant Equipment Design" mean?

What does "GMP-compliant equipment design" mean? This question, which is asked very often, can be answered briefly but not very precisely at first glance. Learn more about a possible answer.

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ECA Good Practice Guide on Equipment Qualification - merging ASTM 2500 and EU Annex 15

Equipment qualification is often complicated, expensive and time-consuming. ECA´s Good Practice Guide "Integrated Qualification and Validation - a guide to effective qualification and validation based on Customer - Supplier Partnership" provides practical advice for leveraging equipment qualification. The guide is in compliance with EU and US regulations and takes into account standard recommendations as those in ASTM E2500.

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GMP Search Engine - Finding what you look for quickly

If you want to find certain news, guidelines, courses, conferences or a comprehensive list of all quickly you may want to try the GMP Search Engine. It allows you to simply search all ECA databases, just guidelines, news or course and conference materials.

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Join the ECA Speaker Team

The more than 150 conferences and training courses the ECA Academy organises per year are supported by more than 200 speakers from the leading pharmaceutical and API manufacturers as well as from medicines authorities like FDA, EMA, PIC/S, WHO etc. Thus, join the team of ECA speakers and benefit from the advantages.

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ECA Publishes New Guide on GMP Compliant Equipment Design

The purpose of this Guide is to illustrate the generally applicable requirements for the design of equipment and to explain how the connection between design and the statement “produced in compliance with GMP” can be made. To this end, the guidance contains numerous references and points of contact, a sort of a road map, that offers detailed information on the requirements or ways of proceeding for individual cases. Read more about the Guide here.

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ECA Foundation's Visual Inspection Group announces new Chairman

The ECA Foundation announced that Felix Krumbein accepted his appointment as new Chairman of the Foundation's Visual Inspection Interest Group.

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