According to the EC GMP Guide, manufacturers of medicinal products are not only obliged only to use GMP compliant APIs and excipients. They also have to evaluate contract manufacturers' and contract labs' qualification. As audits are rather extensive though, a risk-based approach increasingly gains in importance. Please read more here

To fight counterfeit medicines, it will be necessary to establish a series of requirements API and medicines manufacturers have to fulfil. The European Fine Chemicals Group (EFCG) has proposed some measures and has asked the Commission and the Member States to seriously consider their implementation. Please read more here

Industry has already been waiting for the new Process Validation Guideline as the current version has been effective since 1987. At the PAT Conference conducted in Heidelberg end of October, Jon Clark from the FDA gave an outlook on the revision. Please read more here

During courses and conferences authority officials and industry experts regularly answer questions from attendees - this time relative to pre-filled syringes. Please read more here