USP 197 Identification by FT-IR 211.52 Equipment must be adequately maintained

Equipment must be adequately maintained as part of a preventive maintenance program to protect components and dietary supplements from being contaminated by any source

until their quality has been judged to be satisfactory

Any outsourced activity covered by Good Manufacturing Practice or Good Distribution Practice guidelines must be approved by the Quality Control unit

Glossary of the definitions and interpretations of the terms found in section 201 of the Federal Food

The attainment of this quality objective is the responsibility of senior management

USP 197 Identification by FT-IR 211.52 Equipment must be adequately maintainedThe identification of raw materials, intermediates, and products using an IR absorption spectrophotometer to produce a unique fingerprint to compare to a USP standard reference