A Bird Eye View On Pharmacovigilance And Quality Assurance
Year: 2024
Type: article
Abstract: Pharmacovigilance and Quality Assurance (QA) are essential fields in pharmaceuticals dedicated to maintaining drug safety, efficacy, and regulatory compliance throughout a product's lifecycle. Pharmacovigilance emphasizes continuous monitoring, identification, and management of adverse drug reactions (ADRs), incorporating processes such as signal detection, causality assessment, and risk management to safeguard patient safety. QA complements these efforts by enforcing high standards in drug development and manufacturing through Good Manufacturing Practices (GMP), consistent quality checks, and compliance with regulatory standards. Emerging technologies, including artificial intelligence, machine learning, and blockchain, is enhancing the efficiency of adverse event detection and data integrity, while global harmonization efforts seek to unify regulatory frameworks for greater consistency across regions. Together, these fields address the complexities of modern drug development, such as personalized medicine and biologic therapies, supporting proactive risk management and fostering public trust in pharmaceuticals. This review highlights the integrated role of pharmacovigilance and QA in promoting safe, effective, and high-quality drug use, with a forward-looking perspective on digital transformation and global collaboration in advancing patient care.
Author: Chaitali Kulkarni *, Pratiksha Shinde, Aishwarya Shinde
Language: English
Subfield: Toxicology
Domain: Life Sciences
Open Access status: green
OpenAlex ID: W6949209566
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