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Title
Pronađite na jednom mjestu niz korisnih linkova
vezano za različita GMP i GDP područja
EU regulativa
FDA regulativa
FDA current Good Manufacturing Practice - CFR Title 21 Part 210
FDA current Good Manufacturing Practice - CFR Title 21 Part 211
Guidance for Industry: Sterile Drug Products Produces by Aseptic Processing
Guidance for Industry: Process Validation - General Principles and Practices
Guidance for Industry: Part 11, Electronic records, Electronic Signatures
Guidance for Industry: Investigating Out-of-Specification (OOS) Test Results
Guidance for Industry: Quality Systems Approach to Pharmaceutical CGMP Regulations
EMA Q&A
EDQM
EDQM - Certificate of Suitability
Regulatorna tijela
European Medicines Agency (EMA)
Food and Drug Administration (FDA)
Medicines & Healthcare products Regulatory Agency (MHRA)
Hrvatska agencija za lijekove i medicinske proizvode (HALMED)
Javna agencija Republike Slovenije za zdravila in medicinske pripomočke (JAZMP)
Agencija za lekove i medicinska sredstva (ALIMS)
Agencija za lijekove i medicinska sredstva (ALMBIH)
Agencija za ljekove i medicinska sredstva Crne Gore (CALIMS)
Farmaceutska regulativa - Hrvatska
Serijalizacija lijekova
European Medicines Verification System Information (EVI)
Hrvatska organizacija za provjeru autentičnosti lijekova (HOPAL)
Ostale organizacije
European Directorate for the Quality of Medicines (EDQM)
Pharmaceutical Inspection Co-operation Scheme (PIC/S)
The Pharmaceutical Quality Group (PQG)
The International Conference on Harmonisation (ICH)
Pretraživanje EUDRAGMDP baze
QP teme
Covid-19 GMP / GDP
Integritet podataka
PIC/S good practices for data management and integrity in GMP/GDP environments