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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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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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

Mar 15

Supplier Audits: Expectations clarified by Inspectorate ...

What the inspectorates expect regarding supply chain traceability and the role of the QP has been pointed out in a recent blog issued by the British MHRA.

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Mar 15

Use of the Data Matrix Code - Which Regulations apply to Coding? ...

securPharm has released coding regulations by means of the Data Matrix Code. The document also addresses the automated identification of medicinal product packages in the pharmaceutical supply chain. In addition, requirements about clinic packs are also available. Read more about the securPharm regulations on the coding of medicinal products subject to mandatory verification.

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Mar 15

EMA Paper on Dissolution Specification for Generic Products published ...

EMA's "Reflection Paper" from May 2016 on dissolution testing for immediate release of oral dosage forms deals with the specific requirements concerning the tests which should be taken into consideration when submitting applications for a marketing authorisation. Get the details about EMA's Reflection Paper on dissolution specification.

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Mar 08

USA and EU adopt Mutual Recognition Agreement - Does it mean the End of FDA Insp ...

On 2nd March 2017, the US FDA and the EU (EMA) informed that they concluded a so-called MRA (Mutual Recognition Agreement). Such agreements are intended to mutually recognize GMP inspection systems. As a consequence, the GMP Compliance of a site is reviewed by the respective inspection authority. Afterwards, the FDA can use EU inspection results and vice-versa. Read more about the FDA//EU MRA Agreement.

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Mar 08

Inadequate Cleaning and Batch Release in spite of Incomplete Quality Control - W ...

During the inspection of an Indian API facility, FDA investigators found that basic requirements for GMP-compliant manufacturing weren't complied with. This led to a Warning Letter. Read more about the detailed deficiencies in cleaning and validation of test methods, and the maintenance of analytical devices.

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Mar 08

How to perform Cleanroom Monitoring ...

The premises dedicated to the manufacture of medicinal products have to be monitored. Depending on the type of product to manufacture and whether it is a sterile or a non-sterile medicinal product, the requirements for cleanroom monitoring are more or less demanding.

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