Mannitol, parenteral grade (low endotoxin) at Raleigh Drug Product: Auto-approved; 4 quotes; 1 attempt(s); checks 6/7; batches 27/27 feasible.
Auto-approved; 4 quotes; 1 attempt(s); checks 6/7; batches 27/27 feasible.
- Status
- completed
- Approval
- auto
- Transfer
- 302 from SITE-COR, ~7 days
- Purchase
- 280 from Kestrel Polyols (RFQ-115), 19 days + 7 days QC
- covers_need pass transfer 302 + purchase 280 = 582 vs need 582 kg
- lands_in_time pass 35 days available after transfer (cover 49.0 d − safety 14 d); chosen lead time 19 d + QC release 7 d = 26 d
- qualified_only pass Kestrel Polyols is released_for_use
- comparable_quotes pass 4 usable quotes of 4 received on RFQ-115
- batches_feasible pass 27/27 batches on LINE-RAL-AF1, LINE-RAL-LY1 have released material at start (transfer released day 9, purchase released day 26)
- grade_fit pass Kestrel Polyols: parenteral low-endotoxin vs aseptic fill at cleanroom grade A: parenteral, low-endotoxin, USP-NF + Ph. Eur.; lyophilization at cleanroom grade A: parenteral, low-endotoxin, USP-NF + Ph. Eur.; quality rank 3 of 4
- grounded fail Sourcing: "total 12,723.95 USD" for the SUP-004 quote/purchase (implied 582 kg) — contradicts the plan, which shows a 280 kg purchase from SUP-004 valued at 6,122 USD (the remaining 302 kg comes from the SITE-COR transfer).; Sourcing: "Found 4 approved suppliers (SUP-003 ... released_for_use, SUP-005 ... quality_approved, SUP-006 ... quality_approved)" — the facts only establish SUP-004 as released_for_use (qa_packet established_supplier_ids: ["SUP-004"]); the approval status of SUP-003/SUP-005/SUP-006 is not shown, so declaring them approved is ungrounded.; Sourcing: "Only SUP-004's quote ... meets the need-by date ... supplier confirms stock available for immediate shipment to meet 2026-10-17" — contradicts the 19-day lead time and 2026-11-05 arrival, which is after the 2026-10-17 need-by date (the transfer claim itself notes a timing shortfall).