Application-specific documentation streamlines pharmaceutical process and reduces qualification costs
Merck Millipore, the Life Science division of Merck KGaA of Germany, has expanded its EMPROVE raw materials portfolio to 400 active pharmaceutical ingredients, excipients and biopharmaceutical materials. The products offer comprehensive application-specific documentation in addition to superior quality, allowing pharmaceutical manufacturers to reduce qualification costs and accelerate time-to-market processes.
The portfolio includes EMPROVE api for active pharmaceutical ingredients, EMPROVE exp for excipients and EMPROVE bio for biopharmaceutical materials - all of which provide the documentation needed to improve transparency and more efficiently receive necessary approvals. The ready-to-use documentation, prepared in an internationally accepted format, prevents the errors that can result from gathering the information manually, minimising risk to patients. The pre-compiled information also helps streamline the pharmaceutical process by saving both time and money.
Depending on the application, the EMPROVE documentation can contain information such as manufacturer and manufacturing process details, testing procedures, purity and stability data. The active pharmaceutical ingredients are manufactured according to cGMP guideline ICH Q7, the excipients are EXCiPACT certified and the biopharmaceutical materials can be used in both upstream and downstream process steps.
'We are proud to reach the milestone of offering 400 different EMPROVE raw materials to our customers,' said Dr Matthias Bucerius, Head of Pharma Raw Materials. 'This product line has a long-standing history of combining reliability and safety with our deep knowledge of the pharmaceutical industry's ever-changing regulatory requirements, supporting our efforts to help our customers to secure final approvals more efficiently.'
For more information on the EMPROVE product line, please visit www.merckmillipore.com/emprove.