EU GMP Annex 1 Conference

Revision February 2020: New Requirements and Consequences for Industry.

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Weekly GMP Newsletter

The weekly Newsletter is now available here.

Read the GMP Newsletter dated 04.03.2020

Acknowledged GMP/GDP Certification

Highly qualified personnel is crucial in the pharmaceutical industry. The ECA Certification scheme with 14 continuous education programmes trains you adequately.

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GMP/GDP Training Matrix

GMP/GDP Training Matrix

Are you looking for certain GMP/GDP Training Courses? The GMP/GDP Matrix will help you find your training course.

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ECA – Your GMP/GDP Information Source

With news, trainings and conferences, a comprehensive guidelines database, publications and more the ECA is the leading European training and information services provider in the GMP and GDP environment.

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Latest GMP News

Mar 11

UK Changes Import Restrictions for Cannabis ...

UK will implement faster access to medicinal cannabis as import restrictions are changed. Thus, patients will be able to get their treatment in days rather than months.

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Mar 11

Lying in an Inspection? Not a good Idea! ...

A Chinese company was placed on import alert by FDA because investigators observed significant deviations from cGMP. In some cases, the company told the untruth.

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Mar 11

EU implementation of ICH Q12 ...

Following the adoption of the ICH Q12 Guideline in November 2019 the EMA recently published the ICH Q12 Step 5 Guideline and its annexes - together with an Explanatory Note.

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Mar 04

Brexit: MRA will be needed soon ...

Some major European industry associations call for a UK-EU Mutual Recognition Agreement to avoid drug shortages and other problems.

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Mar 04

Annex 1: Consequences for the QP ...

The revised draft of Annex 1 (Manufacture of Sterile Products) was published. There are also some things to consider for QPs.

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Mar 04

What are the GMP Requirements for Supplier Qualification? ...

Supplier Qualification is more than auditing. Supplier qualification can be seen as a risk assessment tool. But what are the exact requirements?

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Upcoming Conferences and Courses

Full-day pre-course session Audit Trail Review

Prague, Czech Republic
17 March 2020

Full-day pre-course session Audit Trail Review
Cleaning Validation

Berlin, Germany
17/18 March 2020

Cleaning Validation
Data Integrity - Requirements for a GMP-compliant Data Life Cycle

Prague, Czech Republic
18-20 March 2020

Data Integrity - Requirements for a GMP-compliant Data Life Cycle
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The GMP Auditor - Initial and Continuous Professional Training for GMP Auditors

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Vienna, Austria

10-12 November 2020

The GMP Auditor - Initial and Continuous Professional Training for GMP Auditors

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training

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Overview about all the courses and conferences, including infos on location, date, fees and the detailed agenda.

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Guidelines say?

Make yourself familiar with what the Guidelines say and get to all important Authority Guidelines.

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GMP App

All GMP information on your smartphone or Tablet PC – with the new free of charge ECA GMP WebApp.

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