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

30.10.2019

 

Dear Sir or Madam,

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

Your ECA Team


Data Integrity Violations detected by the FDA at US Company

Besides several Quality Unit related failures, a Warning Letter of the U.S. FDA mentions an enormous number of Data Integrity violations. Here you can read the remedations expected by the FDA.


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.


ISO Standard for the Production of Pharmaceutical Water

ISO 22519 is a new available international standard dealing with the pretreatment and the production of purified water (PW) and water for injection (WFI).


Webinar: Update IMPs

 

In this Webinar on Wednesday, 13 November 2019 you will learn about the new requirements due to the Clinical Trials Regulation (CTR); especially in regard to labelling, comparators, imports from third countries and the role of the QP. Please see the programme for further information.


Updated Ph. Eur. Chapter on plastic containers

A revision of Ph. Eur. chapter 3.2.2. Plastic containers and closures for pharmaceutical use has been published in Pharmeuropa.


Quality Risk Management Implementation

 

Hear and discuss many practical examples on how to apply Quality Risk Management principles at a course in Barcelona on 20/21 November 2019. Please see the programme for further information.


The new ubiquitous term in aseptic manufacturing - Contamination Control Strategy

With the publication of the draft revision of Annex 1, a term emerges that has not previously been present in this intensity in the guideline - "Contamination Control Strategy".


Isolator Technology Workshop - Engineering, Validation, Operation

 

How to validate and operate Isolators in a GMP compliant way is the content of the ECA course from 26-27 November 2019 in Basel. During 3 workshops at the manufacturing site of Skan you can directly transfer theory into practice. Please see the programme for further information.


In case you missed the previous ECA 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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