FDA - Notification of Deviations in Cell and Tissue Products

Recommendation

7/8 May 2024

Annex 2 & Co. - GMP Compliance for Biopharmaceuticals - Live Online Training
Regulatory Requirements and Practical Implementation

Under 21 CFR 600.14, 606.171 or 1271.350(b), manufacturers are required to notify or report to the FDA in the event of deviations or unexpected events. This also applies to human tissues and cellular and tissue-based products (HCT/P).  In such cases, for example, when the safety, purity or efficacy of a marketed product could be affected - i.e. a Biological Product Deviation (BPD) is present - the following manufacturers are expected to notify the FDA:

• Manufacturers of licensed biological products other than blood and blood components who are licensed for biological products 
• Licensed manufacturers of blood and blood components, including source plasma
• Unlicensed registered blood establishments and transfusion services

Manufacturers of non-reproductive human cells, tissues and cell- and tissue-based products (HCT/Ps) regulated by the FDA exclusively under Section 361 of the Public Health Service Act and 21 CFR Part 1271 are required to submit HCT/P deviation reports to the FDA/CBER) if

• the deviation or unexpected event is affecting a delivered product,
• is related to a requirement of the Core Current Good Tissue Practice [21 CFR 1271.150(b)] and
• relates to the prevention of the transmission of infectious diseases or HCT/P contamination.

The manufacturer is required to report to FDA as soon as possible, but no later than 45 calendar days from the date of discovery of evidence that fundamentally indicates that a reportable event has occurred.

Further details and information on the reporting procedure can be found on the FDA website under Biological Product Deviations. The instructions for creating a "Biological Product Deviation Report" or for electronic transmission are also helpful.