OTC products are safe and effective and consumers freely use them without the need of a drug prescription.
In the United States, production and sale of OTC products are regulated by the Food and Drug Administration (FDA): this Agency requires that manufacturing and control of OTCs comply with cGMP practices (Current Good Manufacturing Practice). Products that are not classified as drugs in the EU might be considered as OTCs in the US according to their real use and other characteristics.
Certain cosmetic products can be considered OTC products when they are characterized by:
- claims that can lead to think that the product is a drug even though it is marketed as a cosmetic item
- active principles that can lead to think that the product is a drug due to its therapeutic use.
- Sun screen products
- Sun filters
- Skin care
- Makeup (with indications on sun protection)
- Deodorants (antiperspirants)
OTC products must be manufactured and controlled according to cGMP requisites for pharmaceuticals intended for human consumption. We can offer the following support:
- Cleaning validation
- Development and validation of methods
- Microbiological and chemical and physical quality control
- Challenge test
- Stability studies
- Photostability studies
- Sample storage
- Tests on USP and OTC monographies
- Regulatory consultancy and support
All our Tests and Services
Full range of scientific tests to support your safety evaluations.
Clinical evaluations in order to demonstrate the efficacy of your product.
Wide range of chemical and physical analyses of cosmetic products in accordance with ICH guidelines.
Characterization and quantification of microorganisms in final cosmetic and personal care products, in intermediate products and for the control of manufacturing environments. We conduct tests to assess the efficiency of antimicrobial preservation agents, as well as sterility and bioburden tests.
To ensure that your products meet quality standards when stored under proper conditions, a safety and stability assessment is required. Mérieux NutriSciences provides a full complement of customizable analytical methods in order to respond to customer requirements on a case-by-case basis.
OTC (over-the-counter) medicines are safe and effective drugs used by the general public without prior recourse to a healthcare professional. OTCs must be manufactured and controlled in accordance with cGMP requirements for pharmaceuticals for human consumption.
Mérieux NutriSciences can help with cGMP compliance in relation to the following:
- Method development and validation
- Quality control
- Stability testing
Human skin is a complex ecosystem with various micro-environmental conditions and skin microbial communities, and it is the home to millions of bacteria, fungi and viruses which compose the skin microbiota.
Skin microbiota is extremely important to the skin health and it plays an essential role in skin protection against external infectious or toxic substances.
Discover more about our services for the Skin Microbiome
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Consumer’s satisfaction and the “Wow effect”
One of the fundamental ingredients to make a product successful is customer’s satisfaction; however, how can their needs be anticipated? Sensory analysis and market research are a sound support in this field.