GMP News - Inspections/Audits

11.02.14

What is FDA Readiness exactly?

Many pharmaceutical companies would like to achieve a so-called "FDA Readiness". But what should be understood under this term? Read more here.

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29.01.14

85 Company listed with GMP-Non Compliance Statements in the New EMA Database

As already reported, the EMA has started listing so-called GMP Non Compliance Statements in the EudraGMDP database in addition to Certificates of GMP Compliance. Now, detailed information has been made publicly available. Read more in the News.

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29.01.14

FDA: more Inspections in 2014

With their new budget, FDA will be able to increase drug plant inspections worldwide and especially in China. Read more.

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18.12.13

FDA plans significant increase of GMP Inspections in China

For quite some time, the US FDA has elaborated concrete plans to increase the number of inspections in China. These plans were developed as a consequence of the Heparin crisis. Based on a new agreement with China, the US FDA will now increase the number of inspections significantly. Read more.

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24.10.13

How to share Audits

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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24.10.13

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

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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22.10.13

New FDA Requirement on the Handling of INDs

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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04.09.13

New FDA Regulation gives the Agency more Power during an Inspection

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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28.08.13

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

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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10.07.13

Frequently Asked Question: How important is Accreditation for Supplier Audits

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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03.07.13

FDA publishes new GMP Guide for Cosmetic Products

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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03.07.13

QbD and RTRT - New Question and Answers published by EMA

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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19.06.13

MHRA implements new Software for risk based Inspection Planning

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

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27.02.13

Are 300 GMP Inspections necessary by 2 July 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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20.02.13

India opens Drug Inspection Office in China

India wants to open its first drug inspection office in Beijing, China on 01 March 2013. Read more.

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