Breaking the Compliance Cycle

As reported in the QMN weekly bulletin, Sun Pharma (Halol, India facility) receives another 483.  This is after an ~ 18 month remediation plan to resolve GMP deficiencies. This poses an interesting question how does a facility break the cycle of failed inspection, remediation, failed inspection, etc.  What does it take to break down the systemic barriers that prevent the formation of a culture focused on quality?  The cost expended in remediation does not seem to be an effective deterrent, nor does products being on an import list.  Do these issues continue based on a lack of leadership, or training, knowledge, or experience – or is something else at the root cause of this problem?

QMN Weekly Bulliten (2017, para 2-3):

The agency said Sun Pharma had also not filed Field Alert Reports to district FDA offices within three days of receiving notice of bacterial contamination and significant chemical, physical, or other, deteriorations in their drugs as required.  The FDA noted six specific instances when reports were not submitted promptly for the antidepressant and smoking cessation drug bupropion.

No assessments confirmed the accuracy of dissolution tests or data, the FDA said. Validation dissolution tests for drugs include studies of specificity, selectivity, precision, intermediate precision and range, but these specific evaluations of method accuracy were not performed. Additionally, testing programs were not well-designed to assess the stability of drug product and controls were not put in place to safeguard manufacturing documents from unauthorized personnel.

The current inspection warning letter is not yet posted.  However, the above issues are similar to the findings in the 2015 warning letter.  With 80% of all API’s and 40% of finished pharma products are manufactured outside of the US, quality failures in remote parts of the world take on a much greater significance. (Consumer Reports, 2014).