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.

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.

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

Contact us to discuss your requirements

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

Contact us

Choose your Region

Please choose your region for an optimized website experience. So we can provide you with the most useful information for your country.

  1. North America
    1. Canada
    2. United States
  2. Europe
    1. Albania
    2. Austria
    3. Belgium
    4. Bosnia-Herzogovina
    5. Bulgaria
    6. Croatia
    7. Czech Republic
    8. Denmark
    9. Finland
    10. France
    11. Germany
    12. Greece
    13. Hungary
    14. Ireland
    15. Italy
    16. Liechtenstein
    17. Luxembourg
    18. Macedonia
    19. Monaco
    20. Netherlands
    21. Norway
    22. Poland
    23. Portugal
    24. Romania
    25. Serbia
    26. Slovakia
    27. Slovenia
    28. Spain
    29. Sweden
    30. Switzerland
    31. United Kingdom
  3. Asia
    1. Bangladesh
    2. China
    3. Hong Kong (incl. Macau)
    4. India
    5. Indonesia
    6. Israel
    7. Japan
    8. Malaysia
    9. Nepal
    10. Singapore
    11. South Korea
    12. Sri Lanka
    13. Taiwan
    14. Thailand