Inputs Required: New Draft Guidelines on Verification of Drugs Analysis Method

The National Agency of Drug and Food Control (Badan Pengawas Obat dan Makanan– “ BPOM ”) is currently preparing a (“ Draft Regulation ”) on Guidelines for the Verification of Analysis Methods for Drugs and Drug Materials (“ Guidelines ”). If ultimately enforced, the Guidelines will serve as a reference during verifications of analysis methods for drugs and drug materials (collectively referred to as “ Drugs ”) ( i.e. procedures for analysis of the identities, purities, physical properties and potentials of certain Drugs) (“ Analysis Methods ”), as well as for BPOM during evaluations of submitted Analysis Method result reports. [1]