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-119), 28 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 28 d + QC release 7 d = 35 d
- qualified_only pass Kestrel Polyols is released_for_use
- comparable_quotes pass 4 usable quotes of 4 received on RFQ-119
- 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 35)
- 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 recommended_supplier_id "SUP-006" and "SUP-006 is the only supplier whose quote lands in time, so it is recommended" — facts select SUP-004 (Kestrel Polyols), qualification_state released_for_use; SUP-006 is not shown as released_for_use; "Only SUP-006 (Corrib Pharma Supply), quote Q-0253, can land by the need-by date ... 24.18 EUR/kg with a 9-day expedited lead time, normalizing to $28.8253/kg landed ($16,776.30 total for 582 kg)" — facts show SUP-004 at $20.3111/kg landed, 28-day lead, qty 280, value_usd 5,687; "The other three quotes do not meet the deadline: SUP-004 (Q-0256, $20.3111/kg landed, 28-day lead) had an expedite option offered but not accepted/formalized" — facts select SUP-004 and the lands_in_time check passes with its 28-day lead; "p_in_time = 0 for all suppliers at the need-by date (days_available = 0)" — facts show days_available: 35