Biological Product Deviation Reports (BPDRs) are coming into increasing focus during FDA inspections.  The FDA commonly requests an understanding of a site’s BPDR process and examples of BPDRs submitted to the Agency.  Furthermore, during the inspection and during evaluation of distributed licensed product, FDA investigators will evaluate “How,” “Why,” and “When” a firm determines the need to issue a BPDR.  This can often be challenging if the firm’s procedures and process for BPDRs are incomplete or lack sufficient detail.  This can put a firm at risk for FDA observations due to failing to notify the Agency as soon as possible, required within forty-five calendar days (21 CFR 600.14(c)).  Therefore, it is important to ensure that your team – which means anyone involved in quality-system decisions (not just the quality organization) – recognizes the need for a BPDR when one arises.

All too often the decision and explanation when a site submits a BPDR is inadequate.

The good news?  The FDA has provided tools for submitting BPDRs.  First, 21 CFR 600.14 delineates the “Who,” “What,” “When,” “How,” and “Where” of submitting a BPDR and the exceptions and considerations that a firm must weigh when considering submitting a BPDR.  Since the regulation’s inception in November 2000, there were subsequent minor revisions to refine and provide greater clarity.  The FDA then provided BPDR guidance Biological Product Deviation Reporting for Licensed Manufacturers of Biological Products Other than Blood and Blood Components in March 2006 and Biological Product Deviation Reporting for Blood and Plasma Establishments in October 2020,.  Both are valuable in establishing a firm’s procedural requirements for its specific licensed product related to BPDRs.

As more biological license applications (BLAs) receive Agency approval, it is necessary for firms to have BPDR processes in place and ensure that they are actively integrating these processes into their quality system with appropriate training and awareness across all necessary stakeholders.  Some organizations that receive these approvals have emerging quality systems that may not have robust BPDR integration.  Then, when an inspection occurs, the preparedness to clearly explain the firm’s BPDR program and demonstrate when a BPDR “is” and “is not” required will demonstrate the necessary compliance posture with this subject.  As with all elements of the Quality System, clearly explaining the BDPR process can be a challenge, and an independent perspective can help ensure that the sites are prepared.

At Lachman Consultant Services, we are often contacted when firms are not prepared for a dialog with investigators or have process gaps, whether it comes to BPDR decisions against a deviation, a complaint/event, or clearly explaining what the BPDR requirements of the license holder are.  All of these scenarios are necessary elements for navigating the BPDR compliance pathway.

So, ask yourself, is your team ready?  Reach out to us at LCS@LachmanConsultants.com for an assessment of your firm’s processes.