Non-Compliance is the biggest threat to growth of the Pharmaceutical and Nutraceutical industry today. The number of warning letters issued by the Food & Drug Administration (FDA) has increased drastically since 2016. The cost of a single non-compliance event is tens of million dollars and this does not even include the loss of market capitalization and reputation. Since the year 2000, drug manufacturers have lost over USD 3 billion for drug safety violations.
Reasons for non-compliance are quite diverse and spread across multiple platforms like people, process and technology. Compliance is an evolving domain and, Nutra and Pharma companies have been slow adapt to any major changes in regulations.
While the reasons for non-compliance are widespread across various aspects such as Process Design, Qualification, Monitoring, Behavior, Systems, etc., here are the Top 3 reasons that have came up recently.
DATA INTEGRITY
The data integrity-related CGMP violations have led to severe consequences for the firms, including warning letters, import alerts, and consent decrees. Some key observations are lack of control over access to computerized systems, non-contemporaneous record-keeping, deletion, falsification, alteration, or other manipulation.
CROSS CONTAMINATION
Cross-contamination has been the most debated compliance topic for some years. Regulators are now looking not only for science-based cleaning acceptance limits but also Statistics based alert limits keeping cleaning process capability in mind.
RELEASE TESTING
Releasing a drug product without a proper assessment of the quality of the drug product leads to this type of issue in the warning letter. Nearly one-fifth of all compliance issues are due to the incorrect or immature release of the product.
ADOPTION OF TECHNOLOGY WITHIN THE INDUSTRY
The Pharma and Nutra industries have been slow in adopting newer technologies. This is often attributed to the regulated nature of the industry as well as a lack of strong IT leadership. Most production and compliance systems are still paper-based. 90% of production facilities don’t use any computerized systems for compliance management.
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