Personal care consumer products in the US encompass a broad spectrum of categories, ranging from food/supplements to cosmetics to OTC drug products. They are mainly regulated by the FDA under the Federal Food, Drug and Cosmetic Act (FFD&C Act).
As is required under Section 501(a)(2)(B) of this act, drugs manufactured in the US must conform to current good manufacturing practices (cGMPs), prescription and OTC alike. GMPs outline regulatory requirements for the manufacturing, processing and packaging of pharmaceutical products to ensure their safety and effectiveness.
The cosmetic good manufacturing practice is a set of manufacturing guidelines to ensure the safety and quality of cosmetic products. Rigorous adherence to good manufacturing practice minimises the risk of adulteration or misbranding of cosmetics.
Both finished dietary supplement products and dietary ingredients are regulated by the FDA as stipulated by the Dietary Supplement Health and Education Act of 1994. Dietary supplements cGMP compliance, such as manufacturing, packaging, labelling and marketing, is required under 21 CFR part 111.
This course aims to provide the participants with a useful, step-by-step guide in setting up a comprehensive GMP programme. It outlines the international development and harmonisation of GMPs relevant to these over-the-counter consumer personal care products with detailed discussion in key areas of concern ranging from the facilities to personnel to material control to corrective/preventative measures and recordkeeping.
Who Should Attend
This 15-hour course focuses on the regulatory requirements of good manufacturing practices for various over-the-counter drugs and consumer/personal care products in the US while also referencing key international counterparts. It is designed for professionals in the personal care (eg. drugs, cosmetics and consumer products) industries engaged in all aspects of product development, including:
- Research and development
- Technology, formulation and product development
- Marketing and technical sales
- Regulatory affairs
- QA and QC professionals
- Business decision makers