Press Announcements 2014

ECA's Working Group "Visual Inspections" nominates Chair

The ECA Foundation established its "Visual Inspections" Working Group in December 2013. Now the group announced the nomination of Dr Tobias Posset as Chair. Learn more.

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The worldwide standard for ICH Q7 Compliance Training

For already 10 years the so called "ICH Q7 Week" has been established as the worldwide leading ICH Q7 training course. Participants from more than 40 countries already attended this qualificaton programme which comprises an ICH Q7 Compliance Training Course and the unique APIC certified Auditor Training Course within one week. The Compliance Training is offered in two courses with focus on either Chemical APIs or on Cell Culture/Fermentation APIs. The updated programme incorporates the consequences from ICH Q9, Q10 and Q11 for API production. Due to the strong demand for this training this year an additional "ICH Q7 Week" will be conducted. Early registration is thus strongly recommended - just visit  www.ichq7-week.org for more information.

GMP in-house Training on Data Integrity

Data integrity is a current hot topic with regulatory agencies either due to falsification of data or bad practices.  FDA inspectors but also EU GMP Inspectors have discovered an increasing number of cases of data falsification in recent years involving both paper and laboratory computerised systems. We take this development into account and offer an in-house GMP Training Course on Data Integrity. We also offer many other GMP in-house training courses.

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Continuous GMP Certification - a new service offered by the ECA Academy

In order to reflect the development of a continuous advanced education for GMP professionals from 2014 on the ECA Academy will issue the Certificates of the Certification Programme with a validity date. Every new Certificate will be valid for two years. Applicants are quite flexible in selecting training courses or conferences for the renewal. As an additional benefit the new Certificates of the GMP Certification Programme will not only include the title of the certification programme but will also list all ECA GMP Training Courses and Conferences you have participated in. Thus, the Certificate will serve as a valid documentation for your continuous GMP Education. Please visit the GMP Certification Page for more information.

GMP Question & Answer Guide

The requirements defined in the GMP Guidelines often leave room for interpretation. However, regulators worldwide (EMA, FDA, TGA etc) sometimes publish frequently asked questions on GMP. In a new ECA document these Q&As are summarized in a single source. The Q&As are structured in 4 main GMP Areas (General GMPs, GMP for APIs, GMP for Medicinal Products, GMP for IMPs). The document contains 150 pages of Q&As and is available at no cost on the ECA Webpage. A first set of ECA Q&As have also been included and additional GMP Q&As are planned for the future. Here you can access the GMP Questions and Answers Guide 

Best practice paper on visual inspection to be published in September 2014

The ECA working group on visual inspection, which was founded this year, is going to publish its first document during the ECA event Particles in Parenterals and beyond. Read more.

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Quality Management Manual of a fictive Company

All participants of the ICH Q10 Training Course offered by the ECA Academy will receive some additional information as part of their conference documentation. Please read more here

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ECA launches the Impurities Forum

The identification and determination of Impurities is a key challenge in pharmaceutical Quality Control. Method Validation, Analytical techniques, Leachables and Extractables are only a few of the problem areas. In addition Elemental (Metal) Impurities and Genotoxic Impurities have caused various uncertainties and questions in industry as well as in authorities. This is why the ECA Academy has set up a comprehensive Impurities Forum with experts from authorities as well as from companies like Boehringer Ingelheim, Novartis Pharma, Baxter, UCB, AstraZeneca, AbbVie and others. To offer a maximum of flexibility the Impurities Forum can be booked for all 3 days or only special parts of interest e.g. on Metal Impurities and/or Genotoxic Impurities. Find out more about the Impurities Forum programme and the options.

Question and Answers on GDP answered by EU Authorities

In order to discuss the interpretation of GDP requirements as laid down in the new EU GDP Guideline we have contacted EU authorities. We asked them about their interpretation of frequent questions, e.g. what is exactly meant by: "product nearing expiry" should be removed from saleable stock? Members of the GDP Group can read the answers of the Danish Authority in the GDP Group Members' Area. Please click here to access the members' area - or fill in the membership application form if you are not a GDP Group member yet.

APIC Audit performed at Excella manufacturing site

The Audit at Excella was initiated by a group of Qualified Persons and QA Managers from different pharmaceutical companies who are using the respective APIs to manufacture their medicinal products. The initiators as well as the Auditee agreed to share the audit reports with other companies. The GMP Audit was performed by a certified APIC Auditor during 3 days at the manufacturing site. Read more on the API Compliance Institute website

GMP and GDP for Excipients - European QP Association and ECA organise joint event

GMP/GDP compliant pharmaceutical excipients are in the center of attention of authorities in Europe and in the US. Hear more about what suitable GMP and GDP standards for excipients may look like and how to use risk considerations as a key point of supplier qualification. An important topic is also the classification of excipients. This ECA and European QP Association will address these challenges in an event in Vienna. Parallel workshops as well as case studies and practical examples are part of the agenda. Read more at www.gmp-excipients.org

GMP Certification and GMP Certificate in Europe - An Overview

Again and again, we receive questions about GMP certification and GMP certificates. Thinking that the procedure for a GMP certification is similar to that of an ISO certification is a common failure, i.e. misunderstanding. The term "GMP certificate" is therefore not quite correct. But what is the correct procedure? An article published on the Concept Heidelberg webpage provides some more information on this topic. Read more about GMP Certification and GMP Certificates.

GMP/GDP Guidance Documents for Pharmaceutical Excipients

Pharmaceutical Excipients need to be manufactured under GMP and GDP. In addition to Guidelines also Checklists are available in order to verify the current status of a supplier. Please find a list of GMP and GDP Guidelines and Checklists for Pharmaceutical Excipients. In addition please see the latest GMP/GDP News for Pharmaceutical Excipients.

Good Distribution Practices News and Discussion Forum

In our GDP News section you will find the latest GDP News with support by our heading organisation, the ECA Foundation. The GDP News are accessible in the public domaine of our website. Please find an overview about the latest GDP News here. In addition we set up a GDP Discussion Forum. Members can publish their GDP questions.

GDP Supplier Database

The GDP Group has been asked by its members to set up a supplier database to help colleagues in the pharmaceutical industry finding suppliers for certain GDP services. If you are working with a supplier organization we kindly ask you to provide some information for our database. The database is a non-commercial service at no costs and is intended to support our members. Please access the GDP Group Members Area to fill in the questionnaire 

GMP Conferences by Topics

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