Part of the pilot phase: Rx-360 audits Merck

Our world is converging. The pharmaceutical industry and raw material suppliers have been feeling the effects for years – and are responding with various initiatives designed to create global standards and cooperation for quality and safety. One example is the Rx-360 Consortium, which was set up jointly by manufacturers and suppliers in 2009. The consortium is working to improve the security and transparency of the pharmaceuticals supply chain, for instance with the 'Joint Audits' pilot program. This program aims for better quality assurance all round, since an independent third-party audit organization audits individual suppliers on behalf of the Rx-360 consortium.

The program's recently launched pilot phase aims to verify feasibility and efficiency so that room for potential improvements to this new program can be detected early on. Merck is one of just a handful of major suppliers to agree to participate in the pilot phase. The audit took place from May 16 to 18, 2011 at our production facilities in Darmstadt and Gernsheim, and produced good results with no major observations.

Once a year, Merck organizes a Pharma Forum for German-speaking customers, to inform them of the latest trends and developments in the industry. The second Pharma Forum, which we organized in June 2011, also confirmed how important an efficient and stringent supplier qualification program is for the pharmaceutical supply chain. Industry representatives discussed ways of securing the supply chain, and shared recent developments in the Rx-360 audit process with participants. We plan to continue this close collaboration in future – for the safety of our customers, and of patients everywhere.



In This Same Issue:

• EMPROVE® bio continues to grow – with TRIS HCl and Gua HCl
• Coming soon to Darmstadt: our new R&D center for formulation
• Work more efficiently – with CellPrime™ animal-free products
• Fewer refusals: Merck now offers group audits