Pharma CAPA (cGMP Solutions)
India has emerged as a premium destination for pharma export, which is evidenced by the fact that it is home to the largest number of USFDA approved drug manufacturing sites outside of the US. According to the pharmaceutical export promotion council of india, The ₹1.1 trillion Indian drug industry exports about 30% of its output to US alone. The dramatic growth of the industry has also spurred a worrying trend of increasing number of warning letters and FDA bans. The industry has been repeatedly advised by USFDA and other regulatory agencies to strengthen its CAPA (corrective & preventive action) practices. Effective CAPA is central to ensuring robust drug quality and world-class pharma manufacturing.
What We Do
SSA’s approach to pharma CAPA hinges on our relentless focus on fostering a solidCAPA culture at all levels of the company. We start by training and skill building of employees on key CAPA toolset with an aim to both empower them as well as to engender a deep belief in a systematic approach to root cause analysis. We encourage them to take up live projects and apply the methodology and toolset taught in class. The learning outcomes include deep understanding of investigation approach, root cause analysis, solution deployment and SOP documentation to prevent future occurrences, statistical analysis for diagnosing root causes and identifying/validating solutions and application of appropriate tools and templates such as FMEA, control plan, fishbone analysis etc. wherever applicable.