Korisni linkovi

U nastavku možete pronaći niz linkova vezano za različita GMP i GDP područja, a koji mogu biti vrlo korisni u svakodnevnom radu.


EU regulativa

EudraLex

EU Good Manufacturing Practice - EudraLex volume 4

API GMP - EU GMP Part II

EU Good Distribution Practice

Directive 2001/83/EC

EMA GMP section

EMA GDP section

Mutal recognition agreements (MRA)


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

WHO GMP standards


EMA Q&A

Quality of medicines Q&A

GMP / GDP Q&A


EDQM

Quality Management (QM) documents


EDQM - Certificate of Suitability

Provjera važećih i odbijenih CEP dokumenata


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

HALMED - farmaceutska regulativa


Serijalizacija lijekova

European Medicines Verification System Information (EVI)

Hrvatska organizacija za provjeru autentičnosti lijekova (HOPAL)

Upitnik za serijalizaciju GMP

Upitnik za serijalizaciju GDP


Ostale organizacije

European Directorate for the Quality of Medicines (EDQM)

Pharmaceutical Inspection Co-operation Scheme (PIC/S)

The Pharmaceutical Quality Group (PQG)

European GDP Association

The International Conference on Harmonisation (ICH)

International Organization for Standardization (ISO)

Hrvatski zavod za norme


Pretraživanje EUDRAGMDP baze

GMP certifikati

GDP certifikati


QP teme

EU GMP Annex 16: Certification by a Qualified Person and Batch Release

European QP Association

QP Code of Practice

QP Study Guide


Covid-19 GMP / GDP

Questions and answers on regulatory expectations for medicinal products


Integritet podataka

PIC/S good practices for data management and integrity in GMP/GDP environments

MHRA’s GxP data integrity guide

FDA data Integrity and Compliance With Drug CGMP