ABSTRACT:
Blister packaging is a preferred system in the pharmaceutical industry for protecting dosage forms and promoting patient compliance, yet it is susceptible to manufacturing defects that can compromise product quality and safety. This study examines common defects such as sticking, binding, black spots, twinning, tablet breakage, and contamination, identifying their probable root causes and proposing remediation strategies. The scope includes analysis of case studies involving missing units, damaged tablets, and visible contamination, alongside evaluation of inspection methods. Key findings indicate that inadequate in-process quality checks (IPQC), poor equipment maintenance, environmental deviations, and insufficient operator training are primary contributors to critical defects. The results emphasize that strengthening in-process quality checks, implementing preventive maintenance, optimizing process parameters, and improving environmental controls can significantly reduce defect incidence. Furthermore, integrating advanced technologies such as real-time monitoring, predictive analytics, and machine learning-based defect detection enhances inspection efficiency and defect prevention. The study concludes that a proactive, technology-driven quality assurance approach is essential to eliminate blister packaging defects, ensure regulatory compliance, maintain therapeutic efficacy, and safeguard patient health. Continuous improvement in inspection and process control not only prevents recalls but also sustains market credibility and public trust.