US Pharmacopeia achieves ISO accreditation for Certified Reference Materials

The US Pharmacopeial (USP) Convention has announced that it has achieved accreditation from ACLASS to the International Organization for Standardization (ISO) Guide 34 for reference material producers (RMP) as an internationally accredited producer of Certified Reference Materials (CRM).

The CRM designation represents additional rigour in the methods used to create, analyse and assign values to reference materials, many of which are well-characterised chemicals that form official USP standards. USP is the only pharmacopeia to have achieved this ISO designation.

According to William Koch, PhD, USP’s chief metrology officer, “This accreditation is a real landmark not only for USP but for public health as well. Measurement technology has made significant strides in the past decades. By adhering to the more stringent criteria required to become an authorised producer of CRM, USP is staying at the forefront of advances to assure the quality, strength and purity of medicines and food ingredients. Those who rely on USP standards worldwide will welcome this additional measure.”

USP is developing criteria to identify which of its reference standards are candidates to become CRM, based on such properties as stability, homogeneity, customer need and others. Over time, in collaboration with stakeholders including manufacturers, regulatory bodies, other pharmacopeias and research scientists, USP will build its CRM library. This will provide manufacturers with greater accuracy and decreased uncertainty about how their products compare to the USP standards with which they must comply. With the ACLASS accreditation, USP intends to release its first CRM in the near future.