Author(s): Ajay G. Pise*, Gayatri H. Tiwaskar, Manasi Choudhari,Devashish Belankar
The pharmaceutical industry places significant importance on maintaining the quality of medications to ensure patient safety and effective treatment. However, the increasing number of warning letters issued by regulatory agencies such as the USFDA, TGA, and MHRA has raised concerns about the deteriorating quality of drugs. This article focuses on manufacturing quality, typical issues highlighted in USFDA483 observations, and the corrective and preventive measures implemented to address these issues. The Corrective and Preventive Action (CAPA) process plays a crucial role in identifying weaknesses, deviations, or incidents and taking immediate preventive action to prevent their recurrence. To improve quality culture, transparency with regulators during audits is essential. Analyzing warning letters issued to pharmaceutical companies is crucial in maintaining manufacturing quality across various drug products.