PHARMACEUTICAL PACKAGING SAFETY: A REVIEW ON EXTRACTABLES AND LEACHABLES AND QUALITY ASSURANCE PRACTICES

Abstract

Pharmaceutical packaging plays a leading role in the safety, stability and efficacy of drug products during their shelf life. However, substances known as extractables and leachables (E&L), which migrate from packaging material into the drug formulation, really compromise the good quality and safety for human life. This article reviews the different sources, types, and toxicological effects of E&L and the latest analytical techniques used for their detection, including GC-MS, UPLC-MS, and QTOF-LCMS. Various worldwide regulatory guidelines, including those of the USFDA and EMA, are discussed, with further emphasis on QA techniques to minimize contamination risks through risk-based approaches and adherence strategies. Real-life examples shall ultimately paint the picture in their application, highlighting actual issues. Consequently, limitations such as the lack of toxicological data and non-harmonized regulations will be tackled. With the promising safer and greener packaging systems, the emerging trends of greener materials and tamper-evident technologies shall also be weighed. This review tries to prove that pharmaceutical packaging needs a multi-disciplinary and internationally harmonized approach to ensure drugsafety and therapeutic efficacy.