DOI: https://doi.org/10.36719/2707-1146/43/5-8
Rafael Abdullayev
Istanbul University
Mahbuba Valiyeva
Azerbaijan Medical University
Doctor of Science in Pharmacy
mahbubav_amu@rambler.ru
Tohfa Nasibova
Azerbaijan Medical University
PhD in Pharmacy
tnesibova@amu.edu.az
INTERNATIONAL PRACTICES ON GMP IN PHARMACEUTICALS
Abstract
Pharmaceutical science encompasses meticulous processes, from initial pharmacological testing to distribution and pharmacovigilance. Each stage demands unwavering precision and adherence to regulatory standards to ensure the quality and safety of medicinal products. This article delineates the multifaceted landscape of pharmaceutical regulations, focusing on Good Manufacturing Practice (GMP) standards as a cornerstone of quality assurance. GMP standards, encompassing GxP principles, mandate adherence to rigorous protocols throughout the drug lifecycle. Within the European Union (EU), GMP standards are codified in directives and regulations governing medicinal products for human and veterinary use. Volume 4 of Eudralex serves as a compendium of EU regulations, providing comprehensive guidelines for pharmaceutical manufacturing.
Mutual Recognition Agreements on GMP inspections between the EU and other jurisdictions aim to facilitate trade and regulatory cooperation, exemplifying international collaboration in pharmaceutical oversight. Recent agreements between the EU and the US FDA streamline inspection processes, reducing redundant inspections and expediting market access for pharmaceutical products.
Moreover, electronic systems such as EudraGMDP enhance transparency and regulatory compliance within the pharmaceutical industry. By evaluating international GMP practices, this article underscores the importance of harmonizing regulatory standards for Good Manufacturing Practices globally.
In conclusion, adherence to GMP standards not only ensures the quality of pharmaceutical products but also plays a pivotal role in the development of pharmacy practices worldwide.
Keywords: Pharmacy, GMP, Eudralex, EMA, FDA, IRIS, Eudra GMDP