Inspiring as I would never have expected, the interview with Joy McElroy, the US-based GMP consultant with 27 years’ experience in the pharmaceutical industry, strikes with a small word: quality.
We talk about the paperwork and procedures companies must own to meet regulatory requirements (sterility assurance, equipment qualification and process validation) and she reveals that the common issues that lead to GMP failures are caused by the desensitisation to the value of genuine quality, from the top management to the manufacturing floor. Fortunately, she says, the mindset is changing and puts on the table advice to thrive in an industry whose core business is to make a positive impact on people’s lives.
Quality has also made headlines on the news front. TTS Pharma, the producer of cannabinoids for use in food, cosmetics and nutraceuticals, released independent analyses of its cannabidiol (CBD) oil and other best-selling CBD products on the UK market. The tests, undertaken by public-private analytical laboratory Fera Science, put TTS as the only manufacturer within the limits of detection of psychoactive compounds THC and CBN and therefore legal under the Misuse of Drugs Regulations. All other samples were contaminated with impurities, exceeded legal limits of psychoactive cannabinoids, and had CBD content labelled inaccurately.
Clearly, the consumer cannabis market has grown to a magnitude that is hard to harness in the interest of public health without the constraints of a regulatory framework and the authority supervision. But, let’s not forget what Cicero, the Roman statesman, already told us: "Any man can make mistakes, but only a fool persists in his error."
N.B. This article is featured in the October 2019 issue of Cleanroom Technology. Subscribe today and get your print copy!
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