The USP Certificate of Document and Reference Standards provides prospect with the knowledge of the effective use of USP standards in the Pharmaceutical industry for the development and manufacture of medicines. Prospects will understand the legality and the science behind the standards, as well as the required industry collaboration in the revision process of the USP Standards. The certificate also provides best practices for the practical application of the USP–NF, USP–NF Supplements, Pharmacopeial Forum and USP Reference Standards – highly characterized chemical specimens.

Subject area:
General Notices and Introductory Courses

Objectives (If applicable):
Introduction to USP-NF
– Find and use the sections, content, publication cycles, and official dates information found in the USP–NF
– Understand the regulatory status of the USP–NF
– Describe the proper use for the Pharmacopeial Forum in the Standard Setting Process
– Use the General Notices to more efficiently navigate the USP–NF
– Explain General Chapters, types of USP–NF monographs and their relationship

Introduction to USP Reference Standards
– Describe the proper use of USP Reference Standards
– Describe the importance of the Reference Standard Development Process
– Determine why USP RS—Regulatory Directives are used

Target Audience (If applicable):
QC/QA personnel and management, regulatory compliance personnel and management, analytical scientist and workbench chemists responsible for quality assessments, regulatory agencies