GMP News - APIs and Excipients

The Certification Scheme for pharmaceutical excipients elaborated by IPEC Americas, IPEC Europe and three further European partner associations contains standards for Good Manufacturing and Distributing Practices as well as requirements for 3rd party audit organisations and their auditors qualification. Learn more about the programme here.

The manufacture of drugs, food, and medical devices is strongly fragmented and largely globalised. Because of this fact, there is an increase in the number of monitored manufacturing sites and imported products. This is a current issue in the USA. To meet new challenges, the FDA reacted with a strategy report. Read more here about the FDA planned change in strategy.

The Falsified Medicines Directive has been adopted by the Council of the European Union on 27 May 2011. It is now about to be published in the Official Journal of the European Union within the next days. It contains substantial changes with respect to GMPs for APIs and pharmaceutical excipients. Please read here more about these new challenges for the API and pharmaceutical industry.

Three new documents published by the IPEC provide useful information for suppliers and users of APIs on Quality by Design at early stages of development.  Read more here.

From 15 April, the European Directorate for the Quality of Medicines and Health Care (EDQM) requires for applications or revisions of a Certification of Suitability (CEP) the indication of the manufacturing site localisation with GPS data or a DUNS number. This change is in line with the requirements laid down in the new EU Site Master File. Read more here

The amendmends to the directive 2001/83/EC regarding the prevention of the entry of falsified medicinal products into the legal supply chain were adopted by the EU Parliament on 15 February. These amendments will affect many central fields of drugs manufacturing. As a consequence, the GMP regulations for pharmaceutical APIs and exicpients are going to be tightened. Read more.