GMP News - APIs and Excipients

In a 46 page report, the Swedish Medical Products Agency (MPA) presents an initiative aiming to introduce environmental constraints into the EU GMP Guidelines. The reason for this is based on the near inexistence of environmental concerns in the countries where the manufacture of APIs is outsourced. Read more here about this initiative.

The WHO Notice of Concern are very similar to FDA Warning Letters. These letters will be issued  to a manufacturer, contract research organization or quality control laboratory, by the WHO Prequalification of Medicines Programme. Read more about the two new Notice of Concerns here

On 1 July 2011 the Falsified Medicines Directive (2011/62EU) has been published in the Official Journal of the European Union. Now the countdown has started for the transposition of the Directive into national law by the EU Member States and for the adoption of Guidelines for APIs and pharmaceutical excipients by the EU Commission. Please read here more about the comprehensive legislation changes to come.

On June 16, 2011 the ICH guideline Q11 on development and manufacture of drug substances (chemical entities and biotechnological/biological entities) was published as a Step 3 document. Read more here.

The EDQM announced on May 17, 2011 the availability of the revised policy document 'Suspension or Withdrawal of a Certificate of Suitability'. The EDQM also annouced information about new CEP suspensions and withdrawals due to failures to comply with the GMP requirements. Read more here.

A new document created by a PIC/S team of APIs experts raises the central issue related to the production and distribution of APIs and provides essential answers and clarification on the topic. Read more about the interesting collection of Questions and Answers here. 

A presentation from Dr Moheb Nasr about FDA´s Pharmaceutical Quality Initiatives was videotaped at the 13th European API Conference in Barcelona. Click here to read more.