Press Announcements 2014

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.

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.

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.

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.

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

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.

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.