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

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

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

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

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

• Warning Letter: Deficiencies in Validation and OOS
• Potential sources for Nitrosamine Impurities
• How to find the key to Ph. Eur. Monographs?

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.

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Yours sincerely,

The ECA Academy

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