USP 197 Identification by FT-IR 211.52 Training by qualified personnel shall

Training by qualified personnel shall be in the particular operations that the employee performs and in relevant GMP

Procedure and report form for the absence of Enterobacteria coliforms in products according to the principles of harmonized method USP <62> and EP 2

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

USP 197 Identification by FT-IR 211.52 Training by qualified personnel shallThe identification of raw materials, intermediates, and products using an IR absorption spectrophotometer to produce a unique fingerprint to compare to a USP standard reference