Press Announcements 2021

ECA Foundation's EQPA changes Membership Requirements

The ECA Foundation's European QP Association revised their requirements for becoming a member in the organisation. Find out more about the Association, its goals and the new requirements.

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New Version of "ICH Q7 Side-by-Side Comparison" Paperback

The newly published paperback "ICH Q7 Side-by-Side Comparison" compares the requirements of the "ICH Q7 Guideline - GMP for Active Pharmaceutical Ingredients" with the interpretations of the revised "How to do" document - APIC's Interpretation of ICH Q7 Guide and "Review form" (Version 15) and explains the requirements of the guideline.

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ECA Foundation's Validation Interest Group announces Change in its Leadership

The ECA Foundation Validation Group's goal is to initiate and facilitate active discussions of current and new regulatory requirements regarding Process Validation and Equipment Qualification. Now the group announced a change in its leadership team.

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FDA´s former Senior Policy Officer Grace McNally speak at ECA´s Launch Conference

At ECA´s Online Launch Conference on 16/17 November 2021 an EU Inspector and FDA´s former Senior Policy Officer, Grace McNally, will share their views on ECA´s Good Practice Guide Integrated Qualification and Validation in the new version 2.0. Grace McNally chaired the workgoup, which has developed FDA´s General Principles and Process Validation Guidance.

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Ongoing/Continued Process Verification with SPC

The author of the article "Practical SPC Rules in the Real World of an Ongoing Process Verification Plan" in the October 2021 issue of the Pharmaceutical Technololgy Journal lectures about this topic at ECA online course.

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Serialization: Update on Improvements of the European Medicines Verification System

Further Improvements of the European Medicines Verification System have been announced for end of 2021 and next year: The Alert Management System (AMS project) and the upcoming EU Hub Release (1.10).

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New Possibilities for Sharing Experiences in implementing Alternative Microbiological Methods

In the context of increasing digitalisation, especially in connection with the pandemic measures of the last 15 months, the ECA's Pharmaceutical Microbiology Group is also exploring new ways to present up-to-date information to its members.

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ECA GMP News Service on Twitter

Get the latest GMP trends quickly and easily anytime and anywhere - with the ECA's service on Twitter.

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GMP for ATMP - Resumee of the First Streaming Event with Live Q&A Session

In june, the ECA ATMP Interest Group organized their first streaming event with 11 hours of information about the European Guidelines on GMP for ATMPs, followed by a live expert discussion.

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European GMP & GDP Forum - the largest Conference of its Kind in Europe

So far, the ECA has been running the GMP and GDP Conference separately every two years. Now, these two events have been combined to create a new platform: the European GMP & GDP Forum.

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Requirements for the Modern Pharmaceutical Laboratory

As every year, the PharmaLab Congress 2021 again focuses on the key questions QC and QA professionals in analytics, bioanalytics and microbiology are facing in their everyday practice.

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Comprehensive Cannabis Roadmap provides GMP/Regulatory Information

Finding GMP and other regulatory information with regard to medicinal cannabis and CBD products is a time-consuming endeavor. The comprehensive Cannabis Roadmap summarizes all the information and documents currently available on a global level.

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PEI & ECA jointly organise Workshop on GMP Compliant Manufacturing of COVID-19 Vaccines

To provide a training opportunity for unexperienced staff and a discussion forum for experienced personnel on specific COVID-19 vaccine-related questions, the Paul-Ehrlich-Institute, the German Federal Institute for Vaccines and Biomedicines and the ECA Academy jointly organise a two day workshop on the GMP Compliant Manufacturing of COVID-19 Vaccines.

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