FDA’s June 2013 Guidance for Industry, Cosmetic Good Manufacturing Practices, has outlined FDA’s thinking and expectations surrounding the quality and control approaches to the manufacture of cosmetic products for the US Market.
The Guidance incorporates principles of ISO 22716 as part of the international harmonization effort with the International Cooperation on Cosmetic Regulations and:
- Addresses raw material standards such as water and color additives;
- Lists prohibited cosmetic ingredients;
- Adds internal audit section requiring regular and demand audits to anticipate problems and implement corrective action; and
- Expands records section to include documentation of all operations, procedures, deviations from procedures, justifications, instructions (including training), specifications, protocols, reports, methods, precautions, corrections, and other information.
A Business Quality System
To address FDA’s “new” expectations and deliver business operating performance, a company needs to have a “Quality System” in place to drive the business processes and control the operations that will ensure compliance with FDA’s expectations. This White Paper will help you to:
- Understand the basic elements and structure of a Cosmetic Quality System;
- Understand how these elements tie to the FDA’s Guidance on Cosmetic Manufacturing; and
- Develop an implementation plan to ensure success with your quality system development initiative.