USP 197 Identification by FT-IR 211.52 or distribution record associated with

or distribution record associated with a batch of a drug product shall be retained for at least 1 year after the expiration date of the batch or

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

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

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

USP 197 Identification by FT-IR 211.52 or distribution record associated withThe identification of raw materials, intermediates, and products using an IR absorption spectrophotometer to produce a unique fingerprint to compare to a USP standard reference