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 (“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]