July 13, 2023 at 09:28PM General Instructions for Completing the Biological Product Deviation Report (BPDR) - Form FDA 3486

For use by biological product manufacturers to report biological product deviations (BPD) that may affect the safety, purity, or potency of a distributed product in accordance with 21 CFR, Part 600.14 or 606.171. Also for use by Human Cells, Tissues and Cellular and Tissue-Based Product (HCT/P) manufacturers to report HCT/P deviations in accordance with 21 CFR 1271.350(b).

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/NP2lvXy