GMP News - APIs and Excipients

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.

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.

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.

APIs produced in third countries in Asia (like China and India) can only be imported into the EU if the regulatory authority of the exporting country will issue a written confirmation of GMP Compliance. The MHRA has published concerns that some APIs might not be available if the authority in the third country will not issue the necessary written confirmation. Please read more.

In addition to the Anti-Counterfeiting Directive 2011/62/EU, an importation certificate must be delivered by the regulatory authority to import APIs from Third Countries into the EU. The EU Commission has recently published such a document for comment. Read more here.

Experts from the European Medicines Agency (EMA) will meet at the end of February to discuss the calculation of the maximal acceptable carry-over for product changes in multipurpose facilities. This will probably lead to changes in the determination of limits for cleaning validation. Moreover, further statements are expected regarding the obligation to manufacture highly active substances in dedicated facilities. Read more here.

On 1st February, 2012; the IPEC Federation announced the successful launch of EXCiPACT - its new, voluntary international certification scheme designed and developed to assure cGMP and cGDP standards are being used in the manufacture and supply of pharmaceutical excipients. Please read more here.