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One of the biggest threats to the growth story of the Indian Pharmaceutical Industry today is non-compliance.
Fremont, CA: The cost of a single non-compliance event is tens of million dollars and does not include the loss of market capitalization and reputation. Since 2000, drug manufacturers have lost more than USD 3 billion for drug safety violations. The reason behind non-compliance is quite diverse and spread throughout people, process, and technology. Compliance is an evolving domain, and pharma companies have been prolonged to adapt to any major changes in regulations.
Here are some emerging trends in non-compliance.
Fifteen years ago, when FDA started issuing warning letters for data integrity warning letters for identified failures in computer system validation, failure to review the laboratory computer systems audit trails, failure to maintain the electronic records, and failure to investigate their disappearance — the volume of warning letters containing a violation of data integrity have grown to 80 percent of all letters issued.
Cross-contamination has been one of the most debated compliance topics in the past few years.
The industry is slowly adopting HBELs (Health-Based Exposure Limits) since EMA (European Medicines Agency) had published its Guideline on setting the health-based exposure limits for use in the risk identification in the manufacture of various medicinal products in shared facilities. Regulators are looking not only for science-based cleaning acceptance limits but also for the Statistics based alert limits keeping cleaning process capability in mind.
Releasing a drug product without a good assessment of the drug product’s quality leads to this kind of issue in the warning letter. Nearly one-fifth of all compliance issues are because of the incorrect or immature release of the product.
Slow Adoption of Technology in Pharmaceuticals
Conventionally, the Pharma industry has been very slow in adopting newer technologies compared to some of the other manufacturing industries like oil & gas, mining, and automobiles. This is usually attributed to the industry’s regulated nature and a lack of strong IT leadership.
Most production and compliance systems are still paper-based and suboptimal. As per a survey, 90 percent of the drug production facilities don’t use any computerized systems for compliance management.