Kneat: Consumer Products Validation

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How does that affect the volume of validation work?

If I were to estimate, I would say that the validation work in consumer health is probably about 10% to 30% of the work you do in pharma.

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Wow. You mentioned about 130 people out of the 850 in the API plants were working on quality. How does that compare to, let's say, a site in consumer health?

You need to be careful with comparisons. The site we had was a launch site, meaning they constantly introduced new products and then transferred those out for large-scale production. In another API plant, you might have only five processes that you produce repeatedly, requiring revalidation. In consumer health, I'm not even sure revalidation is required. You need to do periodic reviews on the ISO standards. For a normal site that continuously produces, you could probably cut the workforce in half. It also depends on the degree of automation, especially in the lab, which is a big portion—two-thirds of the organization. With high automation, you need fewer people. In a consumer plant, like an OTC plant, with standard production and a standard portfolio of products, you can produce the same product repeatedly. Comparing an OTC or pharma plant with routine generics, you probably need about 70% of the workforce compared to pharma. In a consumer plant, you might need 30% to 40% of the personnel compared to a pharma generics plant.

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