Current GMP News and Events. With this newsletter we would like to inform you about the following current GMP trends. Your ECA Team

ECA GMP Newsletter

09.10.2019

Dear Sir or Madam,

With this newsletter we would like to inform you about the following current GMP trends.

Your ECA Team


How to get GMP Certificates, Importation Licenses & Broker Registrations in UK?

The MHRA recently provided details for new licence applications and variations on the agency´s Inspectorate Blog - together with some helpful links.


GMP meets GCP in Hamburg

 

Get to know the essential aspects of the organization and the management of IMP supplies, their distribution and the things to consider during the study. This also inlcudes the important interfaces between GMP and GCP as well as the changes in the regulatory landscape of Clinical Trials. Please see the programme for further information on this course from 15-17 October 2019 in Hamburg, Germany.


From Valsartan to Ranitidine: Nitrosamine Impurities and the Measures taken by the EMA and the EDQM

In June 2018, when it became known that the antihypertensive medicinal product Valsartan contained nitrosamines, no one had any idea how widespread these unwanted side-products were. Read more here to find out what action the EMA and EDQM have taken in the past and in response to the latest cases of nitrosamine contamination.


Webinar: EMA´s Q & A regarding PDE-values

 

Preventing cross contamination is an essential GMP requirement and has already been mentioned in the EU GMP Guideline since its first publication in 1989. There is a stronger focus on cross contamination since the EMA has published their "shared and dedicated facility guideline" regarding the use of multi-purpose equipment. In this guideline, health-based exposure limits (HBEL) and permitted daily exposure-values (PDE) are implemented as state of the art values. A Question and Answers (Q&A) draft document and now the final version is supposed to interpret EMA´s "shared and dedicated facility guideline". But there are still questions. These are discussed in the webinar on 17 October. Please see the programme for further information.


The ICH Q7 Week - Get a worldwide unique certification

The "ICH Q7 Week" has been conducted since the first official publication of "ICH Q7 - GMP for APIs" in the late 90s. With the involvement of 10 speakers, it is the most recognised training course worldwide and includes a unique Auditor Certification Scheme. The co-sponsored week organised jointly by ECA and APIC/CEFIC also covers the latest interpretation Guidelines from APIC/CEFIC and the Auditing Guideline. Please read more about the Certification Scheme on the ICH Q7 Week website.


ICH Q12 - New approach to support innovation

 

The new ICH Q12 guideline will enable full realization of more flexible regulatory approaches to post-approval CMC changes. The draft guideline applies to APIs, drug products, including combination products, and analytical methods. In this webinar on Tuesday, 05 November 2019 you will get to know how ICH Q12 works. Please see the programme for further information.


New video describes services of ECA Foundation

The services offered by the ECA Foundation and its eight interest groups are the subject of a new video, which was posted on the ECA Foundation website. It was taken at the 8th European GMP Conference - today the get-together of GMP and GDOP professionals from Europe and beyond.


Handling of Foreign Particles in APIs and Excipients

 

During this course from 5 - 6 November all relevant aspects regarding the control of foreign particles in APIs will be discussed. You will learn how particles can be identified and controlled and how good practices can be applied to minimise their presence in APIs. Please see the programme for further information.


In case you missed the previous GMP Newsletter, here are the news from last week:

For further recent news please go here.


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Forthcoming GMP/FDA Events

Here you will find an updated overview of forthcoming education courses and conferences.

 

Yours sincerely,

The ECA Academy


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