Quality management system and corporate quality assurance-Reference-Cited by-同舟云学术

Quality management system and corporate quality assurance

Published:2022-12-31 Issue:03 Volume:68 Page:497-498
ISSN:1857-8969
Container-title:Macedonian Pharmaceutical Bulletin
language:en
Short-container-title:Maced. Pharm. Bull.

Author:

Karadžinska Elizabeta¹,Davčeva Jovanoska Marija¹,Velinovska Čadinoska Maja¹,Jovanovska Jankovska Verče¹,Spirovska Burčevska Sonja¹,Ekart Oman Nina²,Miceska Viška³,Gjorgjievska Gabriela⁴,Popstefanova Nada¹,Paneva Olivera¹

Affiliation:

1. ALKALOID AD Skopje, Blvd. Aleksandar Makedonski 12, 1000 Skopje, Republic of North Macedonia

2. Alkaloid INT, Slandrova ulica 4, 1231 Crnuče, Ljubljana, Republic of Slovenia

3. Alkaloid d.o.o.Beograd, Prahovska 3 11000 Belgrade, Republic of Serbia

4. Alkaloid KONS dooel, Blvd. Aleksandar Makedonski 12 1000 Skopje, Republic of North Macedonia

Publisher

Macedonian Pharmaceutical Association

Subject

General Medicine

Link

https://bulletin.mfd.org.mk/volumes/Volume%2068_3/68_3_239.pdf

Reference4 articles.

1. Eudralex - The rules governing Medicinal Products in the European Union, Volume 4: Good Manufacturing Practice, Medicinal Products for human and veterinary use, Chapter 1 Pharmaceutical Quality System. https://ec.europa.eu/health/system/files/2016-11/vol4-chap1_2013-01_en_0.pdf

2. Eudralex - The rules governing Medicinal Products in the European Union, Volume 4: Good Manufacturing Practice, Medicinal Products for human and veterinary use, Chapter 9 Selfinspections. https://ec.europa.eu/health/system/files/2016-11/cap9_en_0.pdf

3. ICH guideline Q10 on pharmaceutical quality system https://www.ema.europa.eu/en/documents/scientific-guideline/international-conference-harmonisation-technical-requirements-registration-pharmaceuticals-human_en.pdf

4. ISO 9001:2015 Quality Management systems