Monitoring the manufacturing and quality of medicines: a fundamental task of pharmacovigilance
Open Access
- 1 January 2021
- journal article
- review article
- Published by SAGE Publications in Therapeutic Advances in Drug Safety
Abstract
Monitoring the manufacturing and quality of medicines: the fundamental task of pharmacovigilance Pharmacovigilance is the science relating to the collection, detection, assessment, monitoring, and prevention of adverse reactions with pharmaceutical products. The collection and assessment of adverse reactions are particularly important in the first decade after marketing authorisation of a drug as the information gathered in this period could help, for example, to identify complications from its use which were unknown before its commercialization. However, when it comes to medicines that have been on the market for a long time there is general acceptance that their safety profile is already well-established and unknown adverse reactions unlikely to occur. Nevertheless, even older medicines, such as generic drugs, can generate new risks. For these drugs a change in the safety profile could be the result of inadequate control of their quality, manufacturing and distribution systems. To overcome such an obstacle, it is necessary to fully integrate manufacturing and pharmacovigilance quality systems in the medicine life-cycle. This could help detect safety hazards and prevent the development of new complications which may arise due to the poor quality of a drug. Pharmacovigilance activities should indeed be included in all phases of the drugs’ manufacturing and distribution process, regardless of their chemical complexity to detect quality-related matters in good time and reduce the risk of safety concerns to a minimum.Keywords
This publication has 13 references indexed in Scilit:
- Hydrochlorothiazide use and risk of nonmelanoma skin cancer: A nationwide case-control study from DenmarkJournal of the American Academy of Dermatology, 2017
- An algorithm to detect unexpected increases in frequency of reports of adverse events in EudraVigilancePharmacoepidemiology and Drug Safety, 2017
- Opportunities for Collaboration at the Interface of Pharmacovigilance and ManufacturingClinical Therapeutics, 2017
- Traceability of Biologics in The Netherlands: An Analysis of Information-Recording Systems in Clinical Practice and Spontaneous ADR ReportsDrug Safety, 2015
- Using VigiBase to Identify Substandard Medicines: Detection Capacity and Key Prerequisites.Drug Safety, 2015
- Incidence of erythropoietin antibody-mediated pure red cell aplasia: the Prospective Immunogenicity Surveillance Registry (PRIMS)Nephrology Dialysis Transplantation, 2014
- Generic Pharmaceuticals: Is Pharmacovigilance Required?Journal of Pharmacovigilance, 2014
- Case Study: Contamination of Heparin with Oversulfated Chondroitin SulfateHandbook of Experimental Pharmacology, 2011
- Contaminated Heparin Associated with Adverse Clinical Events and Activation of the Contact SystemThe New England Journal of Medicine, 2008
- The increased incidence of pure red cell aplasia with an Eprex formulation in uncoated rubber stopper syringesKidney International, 2005