EU GMP Annex 1 released

The EU Commission has published their long-awaited revision draft of Annex 1 "Manufacture of Sterile Medicinal Products".

About The Annex 1 Conference

European GMPs and the Role of the QP

Understand the European approach and the legal framework – and get familiar with the unique roles and responsibilities of the EU QP.

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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 WebAPP – standing out, outstanding

The ECA WebApp lets you have all GMP/GDP information at hand – anytime, anywhere.

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Latest GMP News

Feb 21

EMA's GMP Plans for 2018 ...

The European Medicines Agency has published the 2018 Work Plan. The EMA plans some new guidance and some revisions to existing requirements.

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Feb 21

Disregard of general GMP Principles at Indian API Facility ...

During the inspection of an Indian active pharmaceutical ingredient manufacturer, European GMP inspectors were met with severe deficiencies. Read here, which violations of GMP principles for production, laboratory and handling of reference samples led to a Non-Compliance Report. 

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Feb 21

EMA publishes ICH Q12 Draft with Deadline for Comments ...

The EMA issued the draft of the Guideline ICH Q12 on technical and regulatory considerations for pharmaceutical product lifecycle management and its Annexes for commenting.

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Feb 21

FDA Warning Letter due to Non-Compliance with Specifications ...

The Indian drug manufacturer Kim Chemicals received an FDA Warning Letter in October 2017. During an FDA inspection, it was criticised that not all medicinal products and the active substances they contained had been tested for compliance with the specifications. Find out more about the Kim Chemicals FDA Warning Letter.

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Feb 21

Revised USP Chapter <671> Containers - Performance Testing adopted ...

With USP 41 - NF 36 the revised general chapter <671>  Containers - Performance Testing will become official on May 1, 2018.

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Feb 20

FDA Draft Guideline on reporting Changes to an approved Application ...

At the end of last year, the FDA published a revision draft for their guideline "Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products" which is supposed to take account of the current standards of risk assessment and the submitted data of past change notifications.

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