This is a ready-to-use reportability decision matrix. Because report triggers overlap, the dangerous case is the single event that quietly owes more than one report. Run every new event through this matrix on day one and record each answer; you can decide later that a clock does not apply, with a rationale, but you cannot recover a clock you never noticed. Replace every <<FILL: ...>> placeholder. A filled specimen follows. Verify each cited regulation against the current source; this is general guidance to adapt, not legal advice.
Control header
| Field | Entry |
|---|---|
| Matrix number | <<FILL: FRM-ID>> |
| Governing SOP | <<FILL: SOP-ID for regulatory reporting>> |
| Event reference | <<FILL: deviation / complaint / OOS / AE number>> |
| Product / lot / application | <<FILL>> |
| Screened by / date | <<FILL>> |
The matrix
For each report, apply the trigger test, mark Yes / No / Not applicable, and if Yes, log the clock and due date. The clocks run in parallel, not in sequence.
| Report | Trigger test (all must be true) | Regulatory basis | Who decides | The clock | Yes / No / N/A |
|---|---|---|---|---|---|
| Field Alert Report (FAR) | Approved NDA/ANDA drug AND distributed AND (contamination, significant change/deterioration, stability or spec failure, or mix-up/labeling error) | 21 CFR 314.81(b)(1) | Field Alert coordinator (quality unit) | 3 working days from receipt of information | <<FILL>> |
| Biological Product Deviation Report (BPDR) | Licensed biologic AND distributed AND (cGMP deviation or unexpected event) that MAY affect safety, purity, or potency | 21 CFR 600.14 (606.171 blood) | Quality unit / reporting role | 45 calendar days from discovery | <<FILL>> |
| Expedited (15-day) safety report | Adverse experience that is serious AND unexpected AND a reasonable possibility of association | 21 CFR 314.80 / 600.80 | Pharmacovigilance + safety physician | 15 calendar days from first receipt anywhere in the company | <<FILL>> |
| Recall notification | Firm decides to remove or correct a distributed product it believes violative | 21 CFR Part 7 (7.46) | Recall committee / executive quality | Immediately; in practice within 24 hours for a risk-to-health recall | <<FILL>> |
| Drug shortage (506C) | Permanent discontinuance, OR an interruption in manufacturing of a covered drug likely to disrupt supply | 21 USC 356c | Supply chain + regulatory affairs; quality flags | 6 months ahead if foreseeable, else as soon as practicable | <<FILL>> |
| Combination-product constituent reports | Product is a combination product; add reports driven by each constituent part it contains | 21 CFR Part 4, Subpart B | Regulatory + safety | Per constituent (note: 15-day becomes 30-day if authorized under a device application) | <<FILL>> |
| Combination-product 5-day partner notice | Combination product AND constituent parts held by DIFFERENT applicants AND a qualifying death, serious injury, or adverse experience | 21 CFR 4.103(a) | Applicant holding the information | 5 calendar days from receipt, to the other applicant | <<FILL>> |
Two rules that decide real cases
- The clock starts on receipt or discovery, not on confirmation. You file what you know within the clock and follow up later. A FAR or BPDR filed only after the investigation closes is the classic late report.
- One event can owe several reports at once. An out-of-specification sterility result on a distributed biologic can be a BPDR, the front of a recall, a conditional 15-day trigger, and, if it takes a line down, a 506C notice. Screen all rows every time.
Determination
| Item | Entry |
|---|---|
| Reports owed (from the matrix) | <<FILL: list with clocks and due dates>> |
| Reports assessed not applicable, with rationale | <<FILL>> |
| Logged in the reporting register (row IDs) | <<FILL>> |
| Decision-maker / date | <<FILL>> |
References
21 CFR 314.81(b)(1); 600.14; 606.171; 314.80; 600.80; Part 7 (7.46); 21 USC 356c; 21 CFR Part 4 Subpart B and 4.103.
Confirm the current text and clause numbers of each reference before issue.
Filled specimen
Illustrative screen for a confirmed distributed out-of-specification sterility result on a licensed cell therapy lot (40 units administered/on site, 12 in inventory).
| Report | Trigger applied | Result | Clock |
|---|---|---|---|
| FAR | BLA-licensed, not NDA/ANDA | No | n/a |
| BPDR | Licensed biologic, distributed, may affect safety and purity | Yes | 45 cal days from discovery (today) |
| 15-day | A product-quality event, not yet an adverse experience | Conditional | 15 cal days from first receipt IF a serious unexpected infection is linked |
| Recall | Distributed, sterility failure, risk to health likely | Yes | Immediate; district notified within 24h of the recall decision |
| 506C | Small autologous lot, likely not a covered drug | Screened, not reportable | Basis recorded |
| Combination reports | Not a combination product | N/A | n/a |
The one event set three live clocks (BPDR, recall, and a conditional safety trigger), plus a documented “not reportable” 506C call. Had the team treated it as “just an OOS,” the 24-hour recall notice and the 45-day BPDR would both have been at risk before anyone realized a clock existed.
Common inspection findings this matrix prevents
- A single event that owed multiple reports, but only one was noticed.
- A clock started at confirmation instead of at receipt or discovery.
- A “not reportable” conclusion reached with no documented rationale.
- A combination product where the constituent-part reports and the 5-day partner notice were forgotten.
How to adapt this matrix
- Trim the rows to the report types your products can actually trigger, and add regional reports if you distribute ex-US.
- Put this matrix on the front of your deviation, complaint, and OOS intake so it is run on day one.
- Log every “Yes” into the reporting register and every “No / N/A” with its rationale.
- Confirm every regulation against the current published version before issue.