The need for Quality

  • Erika Barbarosie ZigZag, Innovation Centre, 99 Park Drive Milton Park, Abingdon, Oxfordshire, OX14 4RY, UK
Keywords: Pharmacovigilance, Standard operating procedure, Quality system, Patient Safety

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).

Author Biography

Erika Barbarosie, ZigZag, Innovation Centre, 99 Park Drive Milton Park, Abingdon, Oxfordshire, OX14 4RY, UK

Lead GVP auditor.

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

Published
2022-06-01
How to Cite
1.
Barbarosie E. The need for Quality. jpadr [Internet]. 2022Jun.1 [cited 2022Jul.4];3(2):1-. Available from: https://jpadr.com/index.php/jpadr/article/view/75