-XX%
-XX%
Title
Korisni linkovi
REGULATIVA I SMJERNICE
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
CFR 21 Part 11 Electronic Records & Electronic Signatures
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
WHO smjernice
EMA Q&A
EDQM dokumenti
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 Srbije (ALIMS)
Agencija za lijekove i medicinska sredstva Bosne i Hercegovine (ALMBIH)
Institut za ljekove i medicinska sredstva Crne Gore (CInMED)
Farmaceutska regulativa - Hrvatska
Serijalizacija lijekova
Commission Delegated Regulation 2016/161 - the safety features
Zakon o provedbi Delegirane uredbe 2016/161 - sigurnosne oznake na pakiranjima 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
EU GMP Annex 16: Certification by a Qualified Person and Batch Release
Covid-19 GMP / GDP
Integritet podataka
PIC/S good practices for data management and integrity in GMP/GDP environments