Setting and raising the standards through expert and industry groups
Our APIs are accepted as official reference standards in the leading global pharmacopeias
We have contributed to many reference standards in the world’s two leading pharmacopeias: the European Pharmacopeia (Ph. Eur.) and USP (the U.S. Pharmacopeia). We proposed reference standards for APIs such as amoxicillin, ampicillin, nystatin, cephalexin and cefradine, among others. Many of our drug substances are now accepted as the official reference standards in these pharmacopeias.
One way our company helps to maintain and raise standards in pharmaceuticals internationally is by contributing to expert groups in the European Pharmacopeia.
‘This group establishes the minimum quality criteria required for an antibiotic before it can be distributed within the European market’, says Jan Smeets, Director Regulatory Affairs and member of the Antibiotics Expert Group. ‘I am proud of Centrient Pharmaceuticals’ contribution to these standards.’
We also provide industry groups with advice and feedback. For instance, we work closely with one of the sector groups of Cefic, the Active Pharmaceutical Ingredients Committee (APIC), which represents the European bulk pharmaceutical industry. Several of our Regulatory Affairs and Quality managers play an active role in APIC, and we also have a representative on the executive committee of this group.
"We are a proud contributor to international standards in pharmaceuticals"
Jan Smeets - Director Regulatory Affairs
Furthermore, we have Regulatory Affairs representatives in task forces to oversee the following topics: emerging countries, China registration, elemental impurities, starting materials and Active Substance Master File (ASMF). Quality Managers at Centrient Pharmaceuticals are represented in task forces dealing with data integrity and good distribution Practices. APIC often meets with regulatory authorities to discuss new draft guidelines on the quality of pharmaceuticals.