The full compliance pack on a single plant. Inspections, observations, enforcement events, environmental clearances, and capabilities, joined and citation-anchored.
A pre-audit dossier joins every data source PharmaDB carries about a single plant in one view. Inspection cycles (multi-regulator), observation pattern by 21 CFR category, active enforcement events, environmental clearances, capability codes, and DMF references. The Aurobindo Pharma Medchal example below carries 6 FDA inspection cycles plus 2 EU GMP renewals, 25 cumulative observations across the cycle, and no active enforcement. The full dossier surfaces in under a minute.
| # | Dossier section | What it covers | Rows for Aurobindo Medchal | Source | Status |
|---|---|---|---|---|---|
| 1 | Inspection history | multi-regulator | 8 cycles | 2024-09 | VAI |
| 2 | Observation pattern | 21 CFR taxonomy | 25 observations | see chart | VAI |
| 3 | Active enforcement | compliance_events | 0 active | n/a | NAI |
| 4 | Environmental clearance | MoEFCC India | 3 valid | 2027 | VAI |
| 5 | Capability codes | plant_capabilities | 4 capabilities | current | VAI |
| 6 | DMF references | FDA Type II + EU | 12 active | 2025-11 | VAI |
| 7 | Customs activity | cross-border view | 1 trade lane | current | VAI |
Plant name, address, FEI, EU site ID. Resolves to the canonical plant entity.
Every data source joined at the plant entity. Inspection cycles, observations, enforcement events, capabilities, DMFs, environmental clearances, and trade activity.
Citation-anchored one-page dossier with the qualification recommendation tier. Useful before any onsite audit or RFQ.
Inspections, observations, enforcement, environmental clearances, capabilities, and DMFs are pre-joined. The dossier is the union of every signal PharmaDB carries about the plant.
Improving, flat, or deteriorating across the last five inspection cycles. Sets the audit-team posture: routine, focused, or hostile.
What the plant can manufacture (sterile, controlled substance, biotech) and what environmental clearances are active. Two signals usually missing from FDA-only dossiers.
Every dossier row links to the source record. The auditor can drill into any signal without leaving the brief.
A real chat thread in PharmaDB. Type a question, the AI agent runs the tools, the answer lands as a saveable note.
pharmagraph_query Approximate count of distinct data tables joined per plant dossier · the union of every signal PharmaDB carries.
The pre-audit dossier is the union view per plant. PharmaDB joins every data source it carries about a plant (inspections, enforcement, capabilities, clearances, DMFs, trade) at the plant entity. The view is the canonical plants row with every related table joined. Refresh cadence is weekly for the headline signals.
A one-page (or single-query) view of every compliance, quality, capability, and environmental signal about a specific plant. The pack a buyer or audit team carries into an onsite visit, or that a procurement team reviews before issuing an RFQ. It is the union of every PharmaDB data source resolved to the same plant entity.
Every plant in the catalog has a dossier surface. Coverage depth varies by jurisdiction: India and the US are deepest (multi-regulator inspection plus environmental plus capability plus DMF); China, Korea, and Indonesia are well-covered on inspection and DMF; long-tail jurisdictions vary by signal availability.
Inspections refresh weekly. Compliance events refresh weekly. Environmental clearances refresh quarterly. Capability codes refresh on plant-registration update. The dossier carries an as-of timestamp per section.
Yes. Recommendation tier is one of block, watch, qualifiable-with-conditions, or qualifiable-clean. Computed from inspection trajectory, active enforcement, observation pattern, and environmental clearance status. The tier is advisory; the final decision is the buyer's.
Yes. The dossier exports as a PDF citation pack with every row anchored to its source record. Useful for audit-program documentation and supplier-qualification files.
The capability code overlay surfaces what the plant can manufacture: sterile, controlled-substance, biologic, oncology, high-potency. Two signals usually missing from FDA-only dossiers. Useful for matching a portfolio molecule to the right plant infrastructure.
Bring the molecule, the lane, or the supplier you're sourcing this week. The AI agent runs it on PharmaDB in 30 minutes. You keep the brief.