AABB Suggests Biologics Forms Modifications

Responding to an FDA request for comment on its forms FDA-3486 and FDA-3486A used to report biological product deviations and human cells, tissues, and cellular and tissue-based deviations in manufacturing, AABB asks that the forms be modified to be easier to use by its members and member facilities. The group asks that FDA reduce the burdens associated with the two forms by: 

•          permitting all facilities to attach additional documentation such as a spreadsheet to report a biological product deviation, regardless of the number of products to be reported; and
•          incorporating technology to permit barcode scanning for relevant fields that could reduce typographical human errors.

 The group’s letter says that the changes would “establish a more user-friendly interface, minimize the chance for errors, and accommodate a common manufacturing practice in the cell therapy product manufacturing sector.”