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PARTICLE ENGINEERING
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DIMENSIONE DEL LOTTO
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USO
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AREE TERAPEUTICHE DI COMPETENZA (ATC)
(A) Digestive tract and metabolism
(B) Blood and blood forming organs
(C) Cardiovascular system
(D) Dermatologicals
(G) Genito urinary system and sex hormones
(H) Systemic hormonal preparations excl. sex hormones and insulins
(J) Antiinfectives for systemic use
(L) Antineoplastic and immunomodulating agents
(M) Musculoskeletal system
(N) Nervous system
(P) Antiparasitic products, insecticides and repellents
(R) Respiratory system
(S) Sensory organs
(V01) Allergens
(V04) Diagnostic agents
(V06) Nutrients
(V09-10) Radiopharmaceuticals
OEB (Occupational Exposure Banding)
1 / low-hazard (PDE > 10,000 µg/day)
2 (PDE = 1,000 - 10,000 µg/day)
3 (PDE = 100 - 1.000 µg/giorno)
4 / HPAPI (PDE = 10 - 100 µg/giorno)
5 / HPAPI (PDE < 10 µg/day)
BSL (Livello di sicurezza biologica)
1
2
3
4
SOSTANZE CONTROLLATE
Lowest potential for abuse
Low potential for abuse
Lower potential for abuse
High potential for abuse & medical use
High potential for abuse & no medical use
COMPLIANCE
PMDA (Japan)
TGA (Australia)
MHRA (UK)
Health Canada
NMPA (China GMP)
ANVISA (Brazil)
ISO
Organizzazione Mondiale della Sanità (GMP / HACCP)
ICH
FDA (cGMP)
NSF
EMA (GMP UE)
PMDA/MHLW (Japan GMP)
NMPA (Cina GMP)
Health Canada (Canada GMP)
MHRA (UK GMP)
TGA (Australia GMP)
MFDS/KFDA (Repubblica di Corea GMP)
TITCK (Turkish Health Authorities)
UAE Ministry of Health & Prevention
SFDA (Saudi Food & Drug Authority)
ANMAT (nuove BPF dell'Argentina)
ANVISA (Brazil B-GMP)
ISP (Chile BPM)
INVIMA
MSPAS
COFEPRIS
DIGEMID
Roszdravnadzor (Russia GMP)
IFS
SQF (alimenti di qualità sicuri)
BRCGS
Consiglio di ricerca halal
ECOVADIS
Servizio pubblico francese (CIR)
MERCATI
Rest of World
FDA (USA)
EMA (EU)
PMDA (Japan)
NMPA (China)
MHRA (UK)
Health Canada (Canada)
TGA (Australia)
CDSCO (India)
MFDS (South Korea)
Turkish Health Authorities
EDE (UAE)
SFDA (Saudi Arabia)
ANMAT (Argentina)
ANVISA (Brazil)
ISP (Chile)
INVIMA (Colombia)
MSPAS (Guatemala)
COFEPRIS (Mexico)
DIGEMID (Peru)
Russian Health Authorities
SERVIZI
Development services
Manufacturing services
Analytical / QC services
Quality Assurance services
Regulatory services
Packaging
Logistics