Press Announcements 2022

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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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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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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Current Information for Participants of ECA Academy Training Courses and Conferences during the ongoing Coronavirus Pandemic (SARS-CoV-2)

Due to the ongoing coronavirus pandemic, the ECA Academy is conducting many courses and conferences online. However, occasionally events are possible on-site again. Find out more.

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Free participation in the Online Seminar on the Contamination Control Strategy Guide for participants of PharmaCongress 2022

Are you already registered for PharmaCongress 2022 or are you still planning to register? Then you can take advantage of another benefit. As a registered attendee, you can participate in ECA's Online Seminar on the new Contamination Control Strategy Guide free of charge. Read more here.

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New Developed GDP Pre-Course Reading Material Exclusively for Participants of "GDP for Beginners"

The ECA Live Online Training "GDP for Beginners" will take place on 02/03 March 2022. All participants will exclusively receive a newly developed pre-reading material.

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