GMP News - APIs and Excipients

The United Kingdom has established a webpage about the Directive on the prevention from falsified medicines ("Falsified Medicines Directive"). Read more here about the information contained on this page and learn why it is important to visit it.

The European Medicines Agency has updated its pre-authorisation procedural advice for users of the centralised procedure to reflect new requirements for the submission of active-substance-master-file (ASMF) dossiers as part of human or veterinary marketing-authorisation or variation applications. Go here to read more.

After a successful completed pilot phase, the ExcipactTM scheme will further expand as quality standard for GMP and GDP audits of manufacturers of pharmaceutical excipients. Read more here about the worldwide recognised audit scheme.

The newly formed USP Elemental Impurites Implementation Advisory Group considers issues experienced by manufacturers of products especially affected by the elemental impurities standards. Read more about the output of the Group's last meeting.

As of 1st September 2013, an updated procedure for the renewal and revision of CEPs will apply. By the end of July, the EDQM had already published the respective revised Guidelines and application forms. Read more here about the coming expectations for CEP holders.

The ICH Q3D Guideline on Elemental Impurities has just been published. This Guideline will have a major impact on both the pharmaceutical and the API industry and companies now have  to make efforts to be prepared for the new provisions of the guideline. More details here.

Written Confirmations for pharmaceutical APIs from India to be exported to the EU have been made publicly available by the CDSCO. Read more here.