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To remain 'regulatory compliant' and to ensure the continuity of product supply, systems and processes must be evaluated and the respective processes simplified and controlled. Important tools in this context are accurate Quality Metrics and Performance Indicators.
In October 2016, a facility of the company Qilu for manufacturing the antibiotic Piperacillin exploded. This accident at one production site has led to serious consequences in Germany. Read more here about the reasons and consequences of the supply shortages.
Since January 2013 all imported APIs need to be accompanied by a so called "Written Confirmation" (except a few countries with equivalent GMP standards like the US and Switzerland) which should confirm that the manufacturing site is working under GMP (ICH Q7). But how much does the system help to improve quality of APIs. An investigation of written confirmations issued by the Indian Authorities reveals some surprises. Read more about the Written Confirmations for APIs.
The EDQM has published the next steps for the implementation of the ICH Q3D guideline in the European Pharmacopoeia. Read more here about the changes in the European Pharmacopoeia regarding the control of elemental impurities in different pharmacopoeia monographs.
The US American Food and Drug Administration (FDA) has long been publishing inspection results in so-called Warning Letters. Those letters are freely available on the Internet. Since a few years now, major violations of GMP have been published in a European inspection database. The British Regulatory Authority (MHRA) does this in a much more detailed way. Read the following examples published by the MHRA on the topic area validation/qualification from 2015.