The facility must be FDA-registered as an API drug manufacturer.Zochem has zinc oxide in different packaging types stored in controlled temperature and relative humidity incubation), and significantly more documentation. Products must be produced under a quality system meeting ICH-Q7 GMP (Good Manufacturing Practices) which contains over twice the quality system requirements of an ISO9001:2015 quality system, including validations, ongoing stability study (e.g.There are four major differences between industrial zinc oxide and USP API zinc oxide. These regulations not only affect the contents of these products but the packaging and other surfaces that they come into contact with as well. The Federal Drug Administration (FDA) has established a series of health and safety requirements for such industries as foods, drugs, supplements, cosmetics, veterinary products, and more. Without precise validation of these products, it would be impossible (for example) for pharma manufacturers to document their compliance with FDA requirements.

This is important because pharma products, even over-the-counter products, must precisely identify the percentages of each compound present. Compared to other zinc oxide products, the processes involved in manufacturing are more tightly controlled, with a very high level of ongoing testing. Zinc oxide products that meet USP standards are of the highest quality, purity, and consistency. USP also establishes standards for dietary supplements and food ingredients.

USP (United States Pharmacopeia) is a nonprofit organization that has established a “pharmacopeia” or compendium of information and standards for those manufacturing and packaging pharma products. If you use zinc oxide in any manufacturing process, you may wonder about what makes these products different from other Zochem zinc oxide products. As an extension of Zochem’s industry-leading health, safety, and wellness culture, Zochem offers four different USP or FDA-approved zinc oxide products for every need.

Usp monograph for zinc oxide