This guidance revises the FDA’s “Cosmetic Good Manufacturing (GMP) Guidelines/Inspection Checklist” by updating it to set forth current practice, and clarify certain topics based on recent experience.
According to the Administration, its predecessor contained pre 1990’s material and has therefore become outdated along with "a great deal of progress being made in developing international consensus standards for cosmetics, specifically ISO 22716, [which] we reviewed ISO 22716 and decided to incorporate, modify, or exclude specific aspects of it into this guidance based on our experience.”
In September 2007, the International Cooperation on Cosmetic Regulation (ICCR), met in Belgium where regulators from the US, Canada, the EU, and Japan agreed that it would be useful for the cosmetics industry to have a standardized scheme for GMPs that could apply to their jurisdictions.
As a result, the regulators from these four jurisdictions agreed to take ISO standards for cosmetic GMPs into consideration when developing or updating guidelines or other measures addressing GMPs. In developing this guidance, the Administration has incorporated elements of ISO 22716, as appropriate.
Updated guidelines
The first thing the guidance reminds is that the Federal Food, Drug and Cosmetic Act prohibits the introduction, or delivery for introduction, into interstate commerce of cosmetics that are adulterated or misbranded and that organizations can reduce the risk of adulterating or misbranding cosmetics and effectively conduct a self-inspection to rate their own operations by taking note of the following:
- Documentation - Here; the FDA says organizations should define its' processes and capture every aspect of the manufacturing process as it will prevent errors of interpretation or loss of information that may result from reliance on verbal communication, while also allowing to trace where any problems may have occurred and to take appropriate corrective action.
- Next the Aministration advises that records should be retained in either paper or electronic format and should capture in detail the operations, procedures, deviations from procedures, justifications, instructions (including training), specifications, protocols, reports, methods, precautions, corrections and other measures, and other appropriate information related to GMPs.
- Raw materials - With ingredients, the document suggests that an organization should determine whether they are identified, stored, examined, tested, inventoried, handled, and controlled to ensure they conform to appropriate standards and specifications.
"You should determine whether color additives are approved for use in your specific cosmetic products (21 CFR parts 73, 74, and 82). Should an unlisted color additive be an ingredient of the cosmetic, approval of a petition for a new color additive is required pursuant to 21 CFR parts 70 and 71."
For a full view of the updated guidance document, please see here.