USP Traceable Certified Reference Materials (CRM) are now commercially available. Unlike other reference materials these are traceable to Compendial reference standards and their use is recognized by the FDA, USP and the EP*. Until now, only large Pharmaceutical companies could afford to create their own in-house reference standards.
Now USP Traceable Certified Reference Materials from RTC are available to large and small laboratories alike. They are very economical, contain large sample amounts, and are accompanied by complete, ISO Guide 31 compliant Certificates of Analysis demonstrating traceability to the USP, EP, and BP Compendial reference standards. Purity and identification data is provided for each standard.
Companies are experiencing savings in the hundreds of thousand dollars. With excellent service and technical support the Traceable CRMs have many other uses including method development, validation, R&D, forensics, etc.
Traceable CRM categories presently available:
Active Ingredients
Excipients
Impurities
Residual Solvents
Melting Point Standards
Since USP and FDA laboratories have attained accreditation to ISO/IEC17025 many pharmaceutical companies are beginning to recognize the advantages of accreditation. As laboratories move to accreditation, USP Traceable Certified Reference Materials and the Proficiency Testing Program offered by RTC will help satisfy the requirements.
RTC is accredited with ACLASS to ISO Guide 34 Reference Material Producer (AR-1470), ISO 17025 Testing Laboratory (AT-1467), ISO/IEC 17043:2010 Proficiency Testing Provider (AP-1469) and is registered to ISO 9001.
More information can be found at: www.RT-Pharma.com.
*Guidance for Industry: Analytical Procedures and Methods Validation; Chemistry, Manufacturing, and Controls Documentation.
*USP: <1010>
*EP: 5.12
Source: web of pharmceutical outsourcing
