Explore the Biochemicals Ecosystem

Standards and scheme owners

Bodies that write standards or run certification schemes used in the sector.

Standards and scheme owners

Bodies that write standards or run certification schemes used in the sector.

Organizations to Explore

European Directorate for the Quality of Medicines & HealthCare

Develops international quality standards for medicines and helps organizations apply them. Its work includes the European Pharmacopoeia and cooperation on the quality of health products. EDQM is part of the Council of Europe. This standards role is distinct from the decision to authorize a particular medicine for sale. Geography: Strasbourg, France; European and international standards work.

EXCiPACT

Runs an independent certification scheme for excipient manufacturing, distribution and warehousing. Approved certification bodies conduct the audits under its standards; the site describes a three-year certificate with yearly surveillance. A scheme certificate has a defined scope and is not approval of every product or a medicine marketing authorization. Geography: Brussels, Belgium; international certification scheme.

National Institute of Standards and Technology

Develops measurement methods, reference materials and reference data for biomolecules. Its Biomolecular Measurement Division studies proteins, nucleic acids, peptides, glycans, metabolites and lipids with industry and research partners. This evidence establishes measurement support, not certification of an ingredient supplier or acceptance of every commercial assay. Geography: United States; international research partnerships.

Sources

EXCiPACT official evidence

Read the source for scope and details.

EXCiPACT official page

Read the source for scope and details.