The tragic news of 66 Gambian children dying after consuming Indian cough syrups has sent shockwaves through the world.
The WHO has said that it has found ‘unacceptable amounts’ of diethylene glycol in the syrups, which when consumed can cause life-threatening gastrointestinal symptoms.
Despite the Food and Drug Administration (FDA) stressing on adherence to regulatory compliances, there are several companies in the world today that are failing to do so. There is no tolerance for error in the pharmaceutical industry and the unfortunate tragedy that occurred is a stark example of the repercussions of non-compliance.
Speaking of non-compliance, a few alarming trends emerge when we go over the warning letter issued by the Food and Drug Administration (FDA) between FY2013 and FY2018 (refer Table 1 below).
The number of warning letters issued keep going up each year and a majority of the 483s cite data integrity as an issue. In FY2018, for example, data integrity deficiencies were cited in 57 percent of all warning letters (excluding those issued to compounding pharmacies).
Yes, the FDA has become stricter with their inspections each year, but warning letters issued over the years indicate that many pharmaceutical companies continue to struggle to meet the compliance criteria for a few basic, yet critical rules.
These observations raise a bunch of questions…
Why are so many pharmaceutical companies failing to meet certain compliance criteria time and time again?
What is the root cause behind some problems persisting over the years, such as lack of data integrity?
Is it a competence issue with staff or does the fault lie with the SOPs?
And what are the companies complying with the regulations doing differently?
Table 1: Breakdown of FDA 483s for the period FY2013 to FY2018
Source: An Analysis of FDA FY2018 Drug GMP Warning Letters (pharmaceuticalonline.com)
Over the years, the Food and Drug Administration (FDA) has cited the failure to implement a reliable process monitoring program to ensure better control over the manufacturing process as a problem area pharma companies should work on.
The obvious information that we can glean from this is that pharma companies need to embrace automation and digitization in order to meet the compliance criteria. With the industry known for its stringent guidelines, this should have seemed obvious. But, according to a global McKinsey study, the pharma industry ranks quite low in terms of digital maturity and has been slow to adapt to new technology. For more information, visit https://www.pharmision.barcodeindia.com/blogs/why-pharma-companies-need-to-automate-manufacturing-processes-today/
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