Methodology · v1.1

GMAGMP-Herstellungserlaubnis

Manufacturing-quality authorisation + inspection track record for {legal_name} (manufacturer/importer of regulated health products). EXTRACTION RULES: a licensed, regularly-inspected manufacturer is the STRONGEST reliability signal in health-pharma. PICK THE REGIME THAT MATCHES THE PRODUCT TYPE (do NOT force pharma-GMP onto a pure device maker, and vice-versa): • MEDICINAL PRODUCTS (pharma/biotech with own drug production) — search the European database EudraGMDP (eudragmdp.ema.europa.eu) for the company's GMP certificate(s) and Manufacturing/Importation Authorisation (MIA), the national authority (AIFA aifa.gov.it for IT, the national medicines agency otherwise), and the FDA establishment registration / EIR (fda.gov) for US sites. • MEDICAL DEVICES / IVD (device maker, no medicinal-product GMP) — devices do NOT sit on EudraGMDP; search for an ISO 13485 quality-management certificate, a Notified Body certificate under MDR (EU 2017/745) / IVDR (EU 2017/746) with CE marking, and FDA 21 CFR 820 (QSR) registration / inspection (FDA establishment registration & 483/EIR) for US. Treat these as the GMP-EQUIVALENT evidence and score them on the SAME reliability bands below. Return type="composite_signal" with sub-signals, each 0-100 + source_url: (a) gmp_certificate_active — a valid, in-date GMP certificate (medicinal) OR ISO 13485 / Notified-Body MDR-IVDR certificate (device) for at least one site → 90; expired/under remediation → 50; none found for a verified manufacturer → 30; (b) manufacturing_authorisation_active — an active MIA / manufacturing licence OR CE marking / FDA-registered establishment → 90; only importer/wholesaler authorisation → 65; none → 30; (c) inspection_outcome — most recent GMP/QSR inspection with NO critical findings / "compliant" status → 90; minor findings resolved → 70; statement of non-compliance / suspended certificate → 20. If {legal_name} is verifiably NOT a manufacturer (pure R&D/licensing biotech, no own production) return type="absent" reason="no_company_specific_data" (the index then N/A, not a penalty); same for a device that genuinely has no published certificate/registration anywhere. Server composite_signal_score.