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GMP audits. Links related:

ICH
PIC/S
APIC

 

ICH (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use)

WHO, medicines quality assurance guidelines

EU Legislation - EudraLex

Guía de Normas de Correcta Fabricación de la UNIÓN EUROPEA. Medicamentos de uso humano y uso veterinario

CFR (Code of Federal Regulations)

21 CFR 210, Good Manufacturing Practices

21 CFR 211, Good Manufacturing Practices

21 CFR Vol. 8, Medical Devices

21 CFR 820, Quality System Regulation -Medical Devices-

FDA Guidance Documents (Drugs)

FDA, Newly Added Guidance Documents

FDA Guides to Inspection

PIC (Pharmaceutical Inspection Convention)

APIC (Active Pharmaceutical Ingredients Committee)

EMA, News and Updates on Pharmaceuticals

 

PIC/S, GMP Guide PE 009-17/2023 (Full. Intro; Part I Basic Requirements for Medicinal Products; Part II Basic Requirements for APIs; Annexes)

ANMAT, Disposición Nº 4159/23. "GUIDE OF GOOD MANUFACTURING PRACTICES FOR MANUFACTURERS, IMPORTERS / EXPORTERS OF MEDICINES FOR HUMAN USE ". (ARG)

ANMAT, Disposición Nº 5068/19. "Application for Bio-exemption and APPENDIX" (ARG)

ANMAT, Disposition 7298/19. "Classification of Deficiencies of Good Medicine Manufacturing Practices." -EX Disp Nº 2372/08. "Guide for Inspectors on Good Practices for the Manufacture of Medicines."-. (ARG)

COFEPRIS, NOM-059-SSA1-2015. "Good medicine manufacturing practices." (MEX)

COFEPRIS, NOM-164-SSA1-2015. "Good manufacturing practices for drugs." (MEX)
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