The weather is changing as a new season begins and it’s time
to review recent FDA activity in the cosmetic sector. In June 2013 FDA published a draft guidance
revising the Good Manufacturing Practices for cosmetics. While these GMPs
remain voluntary, FDA Agents will use these guidelines when inspecting cosmetic
facilities.
FDA first published cosmetic GMP inspection guidelines in
1997 and updated them in 2008. FDA participates in the International
Cooperation on Cosmetic Regulations (ICCR) and this latest update incorporates portions
of the International Organization for Standardization’s (ISO’s) current
standard for cosmetic GMPs (ISO 22716:2007)
The new guidance expands the section on documentation and
record keeping; placing this information at the beginning of the guidance. The sections on facilities, equipment, personnel,
raw materials, production and laboratory controls are expanded as well. There are new sections on water used as an
ingredient, color additives and prohibited cosmetic ingredients.
The section on water used as a cosmetic ingredient states in
part that the water is to be of defined quality and is to be tested or
monitored to verify that it “meets applicable chemical, physical and microbiological
specifications for quality”. It is also
noted that the water system “should be routinely cleaned and sanitized
according to an appropriate SOP that ensures no biofilm build-up.”
Surprisingly, the new guidance omits the section on labeling
that was included in the older version.
It is unlikely that FDA inspectors will skip label reviews during an
inspection since labeling requirements are codified in regulations.
Although the revised draft guidance does not have the force
of law, if it is followed, it can help you ensure that your production facility
would pass inspection. The full guidance
may be viewed at http://www.fda.gov/Cosmetics/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/ucm353046.htm?source=govdelivery.
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Kind regards,
Evelyn & Associates
