PromoCell is now EXCiPACT™ GMP certified

We have successfully completed a comprehensive EXCiPACT™ audit that certifies PromoCell as a manufacturer of pharmaceutical excipients to Good Manufacturing Practice (GMP) standards. This means we can now provide tailor-made cell culture media and reagents based on your regulatory requirements.

Excipact Main

The EXCiPACT™ certification scheme for pharmaceutical excipients provides a GMP standard that is accepted worldwide and builds on our existing ISO 9001:2015 quality management system. In addition, this is fully aligned with the American National Standard for Good Manufacturing Practices according to NSF/IPEC/ANSI 363.

This certification has a number of benefits for our customers:

– Minimizes risk
– Reduces regulatory burden
– Saves on cost and time

This certification minimizes risk for our customers by ensuring the high quality of our cell culture media and reagents when used as pharmaceutical excipients. We manufacture our products using the highest quality raw materials and in adherence to GMP standards as published by IPEC (International Pharmaceutical Excipients Council) in the Joint Good Manufacturing Practice Guide for Pharmaceutical Excipients.Logo BASF

The EXCiPACT™ GMP standard for pharmaceutical excipients enables us to serve the growing demand of researchers planning to work with our products under a regulated environment. This is achieved by a streamlined definition of raw material specifications and documentation required from our customers, thus reducing the regulatory burden, and ultimately saving cost and time.

 

Read the interview at News-Medical with Dr. Irma Börcsök (CEO) and Dörte Keimer (Head of Quality Assurance) of PromoCell regarding the company’s EXCiPACT GMP certification

Excipact

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We aid you in choosing the right cell culture media product for your specific application based on your process and regulatory requirements.

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