GMP News - APIs and Excipients


FDA seeks getting on the List of Third Countries with equivalent GMP Standards

The US FDA seeks getting on the list of so called third countries and has therefore filed a listing request. Find out more.



European Commission Publishes Extended Question/Answer Document on Written Confirmation

The EU Commission has recently published an extended Question and Answer Document on APIs importation into the EU and the "Written Confirmation". In addition, an up-to-date version of the "Written Confirmation" form has been released. Read more here about the changes made in both documents.



Guidelines for formalised Risk Assessment of pharmaceutical Excipients issued

Recently the EU Commission issued draft guidelines on the formalised risk assessment of pharmaceutical excipients. These drafts comprise definite specifications for determining the risk profile of the excipient and the manufacturer which the pharmaceutical manufacturer using these excipients has to apply. Read more.



New MHRA Q & A Document on the Import of Active Pharmaceutical Ingredients

The British regulatory authority MHRA has published a new questions-and-answers document concerning the new rules on the import of active ingredients laid down in the Directive 2011/62/EU on the prevention of the entry of falsified medicinal products. Read more here.



ICH plans Q&A on ICH Q7

The International Committee for Harmonisation (ICH) has published a concept paper on 17 October 2012. According to the announcement the ICH Implementation Working Group (Q7 IWG) is currently working on a Q7 Question and Answer document. Go here to read more.



EU Commission publishes Version 2.0 of the Question and Answer Document on API Importation

The European Commission has published a Version 2.0 of the Q&A document "Importation of Active Substances for Medicinal Products for human use" on 26 October. Version 1.0 was published on 10 July 2013. Please read more here.



Additional Guidance Document on Active Substance Master File (ASMF) published by EMA

The European Medicines Agency (EMA) has published an additional Guidance document relating to Active substance Master Files (formerly known as European Drug Master File). Find out more.



Chinese API Manufacturers revealed to have used gutter oil for the Manufacture of Antibiotics

Local Chinese authorities are currently investigating against a few renowned API manufacturers who are accused of having used waste oil from restaurants for the production of their antibiotics. China's largest API manufacturers are among the accused manufacturers. Read more.



Extension of Directive 2003/94/EC to GMP for APIs - EU Commission publishes Comments on Concept Paper

The intention of the EU Commission to integrate GMP regulations for APIs into the existing Directive 2003/94/EC via a delegated act faces rejection from companies and industry associations. Their comments on the respective concept paper from the EU Commission have been recently published. Read more here.



Chinese SFDA issues new Regulation on a strengthened Supervision of Pharmaceutical Excipients' Manufacturers

The new regulation of the Chinese State Food and Drug Administration defines a strengthened supervision of the manufacture of pharmaceutical excipients. Read here who will be affected by these new provisions.



New Rules for the Importation of APIs - a European Commission Leaflet provides Information

The new rules for the importation of active pharmaceutical ingredients will already enter into force next year. As of 2 July 2013 each consignment of active substances imported into the EU must be accompanied by a written GMP conformity certificate. The European Commission comments once again the most important questions concerning the written confirmation in an information leaflet. Read more here.



EDQM publishes Guidance on Notifications of Changes of CEPs

The EDQM has recently published a document intended as a guide for the renewal or revision of a certificate of suitability. The EDQM hopes that this will reduce the time needed for the procedure and limit requests for additional information from CEP holders. Read more about this very helpful document here.



Top 10 Deficiencies - Applications for Certificates of Suitability (CEP)

The EDQM has published a document about the most frequent deficiencies found in application dossiers for CEPs and gives recommendations on how to avoid such errors. Read more here about these "Top Ten Deficiencies".



Continuing Trend: Again, Numerous Warning Letters issued to European API Manufacturers

For some time now, the FDA has been strengthening its inspection activities at API facilities not only in the Far East but also in Europe. The analysis of the 8 Warning Letters which have already been issued for fiscal year 2012 confirms this trend. Read more here about what FDA investigators mostly have to object to in European facilities.



EU GMP Part 3: New Final Document on Written Confirmation

On 10 July 2012, the European Commission published the final Template for the 'written confirmation' for active substances. Please read more here


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