GMPs for OTC and Cosmetic Products

Over the Counter (OTC) and personal care or cosmetic products constitute a very huge market in the US and the EU. Since they are in very wide usage in these huge markets; they are regulated.

In the US, these types of products are regulated by the Federal Food, Drug and Cosmetic Act (FFD&C Act), under which both these products fall. One of the foremost requirements of this Act is that these products must adhere to current Good Manufacturing Practices (cGMPs), a mandatory requirement spelt out in Section 501(a)(2)(B) of this Act.

What are cGMPs for OTC and cosmetic products?

Good Manufacturing Practices (GMPs) and cGMPs are standards and regulations that spell out the manufacturing, processing and packaging regulatory requirements with the aim of ensuring products’ effectiveness and safety. The FFD&C Act strictly prohibits adulteration and misbranding in cosmetics and OTC products that are introduced into interstate commerce, as part of GMPs for OTC and cosmetic products.

A regulation in a dual category

GMPs for OTC and cosmetic products, which are guided by regulations, fall into a dual category. GMPs for OTC and cosmetic products are framed on the criteria which determine the nature of the products. The deciding factor on which GMPs for OTC and cosmetic products are made is in determining whether the product is a cosmetic, a drug or both. The FDA regulates its GMPs for OTC and cosmetic products on the logic that OTC and cosmetic products constitute both a drug and a cosmetic, depending on its intended use. Since many OTC drugs and cosmetic products can be used as both, FDA regulations on GMPs for OTC and cosmetic products treat these as both.


The USFDA and EU prescribe and regulate GMPs for OTC and cosmetic products by coordinating and harmonizing these regulations globally. The aim is to facilitate discussion of best practices and impart best practices to personnel involved in this area. GMPs for OTC and cosmetic products also include monitoring materials, taking corrective and preventative actions and measures, and maintaining proper recordkeeping.

The Quality Systems Manual has details relating to these. The main categories on GMPs for OTC and cosmetic products include

  • Maintaining of SOPs
  • GMPs for OTC and cosmetic products relating to the running of personnel training, facilities and equipment qualification
  • Process validation
  • Specifications relating to products and their components
  • Controls for labeling and packaging
  • Activities that take place in the laboratory
  • Monitoring of shipping and warehousing
  • Care and validation of water systems
  • Mechanism for recalls and complaints
  • Method for handling FDA inspections.
For the EU

For the EU, a reliable guide on GMPs for OTC and cosmetic products is the “Guidelines for Good Manufacturing Practice of Cosmetic Products (GMPC)”, which the Council of Europe published in 1995 and the European Cosmetic Toiletry and Perfumery Association (Colipa).

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