Supply chain guidance in the works
This article was originally published in The Gold Sheet
Executive Summary
FDA plans to issue several supply-chain-related guidance documents in the coming year, the agency said in its annual guidance agenda, published Aug. 7 in the Federal Register. The commissioner's office is working on guidance for good importer practices. The Center for Drug Evaluation and Research has guidance in the works on active pharmaceutical ingredients, as well as on adding physical-chemical identifiers to solid oral dosage forms for anti-counterfeiting. The notice indicates other drug quality related guidance documents in preparation, including ones on annually reportable post-approval changes and parametric release (see story p. 1) as well as immunogenicity assessment; immunogenicity related assay development; standards recognition; penicillin definition, nonpenicillin beta-lactam contamination; process validation; genotoxic and carcinogenic impurities; and private labs