News

24.10.2013

Because of ongoing globalisation and outsourcing activities, more and more audits have to be performed. A possibility in saving resources is sharing an audit. Read more about a service offered by the European QP Association.

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FDA publishes List of GMP facilities producing for the US market (generic drug products and APIs)

24.10.2013

The US FDA has published a comprehensive list of facilities that produce Finished Dosage Forms, APIs under the Generic Drug User Fee Act. Please read more about this list.

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New FDA Requirement on the Handling of INDs

22.10.2013

A new FDA document is supposed to provide a consistent approach to the handling of submissions of investigational new drug applications (INDs) within the Center for Drug Evaluation and Research (CDER). This concerns the processes within the FDA as well as the communication with the applicant. More information is available in this News.

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New FDA Regulation gives the Agency more Power during an Inspection

04.09.2013

FDA is proposing a regulation to implement administrative detention authority during inspections, which might present a new risk to facilities. Read more.

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Frequently asked GMP question: How should active substance auditors be qualified?

28.08.2013

From time to time we receive "GMP questions" from ECA Members. Please read the anwer to this question in our GMP News

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Frequently Asked Question: How important is Accreditation for Supplier Audits

10.07.2013

We regularly receive questions related to GMP compliance issues. One of the most asked question addresses the topic accreditation of bodies that perform Third Party Audits. Read more in the GMP News.

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FDA publishes new GMP Guide for Cosmetic Products

03.07.2013

On June 25, 2013 the US FDA published a new Good Manufacturing Practice Guide for Cosmetic Products. Please read more here.

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QbD and RTRT - New Question and Answers published by EMA

03.07.2013

The level of cooperation between inspectors and assessors when handling "QbD" applications involving RTRT (Real Time Release Testing) was added to the Q&A part of the EMA's website in June 2013. More information can be found in the News.

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MHRA implements new Software for risk based Inspection Planning

19.06.2013

Medicines regulator implements innovative software to analyse risk data and target inspection activity. Read more.

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Are 300 GMP Inspections necessary by 2 July 2013?

27.02.2013

The heads of the EU authorities for medicines are organised in a group called Heads of Medicines Agencies. In a meeting which took place in Dublin just recently, the Committee identified the need for GMP inspections to be conducted at API manufacturing sites by the 2nd of July 2013. Read more.

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