The need for Quality
Abstract
Hearing about pharmacovigilance (PV) and patient safety, both non-professionals and professionals tend to focus only on the safety aspect of the story; most of us were guilty of that at a point in our careers, but what about Quality? Where does it fit, and how does it help?
The "holy" triangle includes safety, efficacy and also quality. Undoubtedly, the quality element should be built into PV to ensure high standards, efficient workload management, the safety of our patients and public health. This article aims to guide readers through the starting points of integrating Quality into PV related processes, focusing on Standard operating procedures (SOPs).
References
eCFR: 21 CFR Part 820 - Quality System Regulation. Retrieved on 12 April 2022, from https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-820
Good pharmacovigilance practices - European Medicines Agency. Retrieved on 12 April 2022, from https://www.ema.europa.eu/en/human-regulatory/post-authorisation/pharmacovigilance/good-pharmacovigilance-practices
EudraLex - Volume 4. Retrieved on 12 April 2022, from https://ec.europa.eu/health/medicinal-products/eudralex/eudralex-volume-4_en
ISO 9001:2015. Retrieved on 12 April 2022, from https://www.iso.org/standard/62085.html
Pharmaceutical Quality System Q10. Retrieved on 12 April 2022, from https://database.ich.org/sites/default/files/Q10%20Guideline.pdf
Copyright (c) 2022 Erika Barbarosie
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