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Cosmetic GMP Implementation Part 1
Cosmetic GMP Implementation Part 1
SAFETY
Basic Rule of Thumb
• Whether imported, exported or made within
the country, cosmetics MUST be in
compliance with the provisions of the
regulations of the country of sales, and may
also need to be in compliance with the
regulations with the country of manufacture.
Cosmetic GMP Regulations
• US Cosmetic GMPs
– FD&C Act [Sec. 301] prohibits introduction, or
delivery for introduction, into interstate commerce
cosmetics that are
• adulterated [Sec. 601], or
• misbranded [Sec. 602].
– FDA has authority to inspect firms, establishment,
equipment, unfinished and finished materials,
containers and labeling [Sec. 704]
Cosmetic GMP Regulations
• EU Cosmetic GMPs
• Guidelines aimed at cosmetics manufacturers in
order to improve safety, offer organisational and
practical advice on the management of the human,
technical and administrative factors affecting product
quality.
• Describe the manufacturing conditions and
management activities involved in the different stages
of production, from the purchase of the raw materials
to the dispatch of the packaged end-products.
• Current Requirement Reference: ISO 22716
European Cosmetic Directive
• Article 5.1 “Good Manufacturing Practice” requires that
“Manufacturing of cosmetic products shall comply with good
manufacturing practice…..”
• Article 5.2. states that “Compliance to good manufacturing
practice shall be presumed where manufacturing is in
accordance with the relevant harmonized standard,…..”
• The ISO standard 22716 (2007) ”Cosmetics – Good
Manufacturing Practices (GMP) – Guidelines on Good
Manufacturing Practices” has been approved an published in
2007 and is becoming more and more accepted at
international level.
• It is expected that this standard will become a harmonized
standard soon after the publication of the new cosmetic
regulation (2013)
• Therefore compliance to this standard will guarantee
compliance to Article 5 of the cosmetic regulation.
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Cosmetic GMP Regulations
• ASEAN Cosmetic GMPs
– Driven by Article 8.1.c [ASEAN Cosmetic Directive]
• Follows primarily EU activities
• Guidelines intended as a general guideline for the
manufacturers to develop its own internal quality
management system and procedures
• Goal:
– “The final products must meet the quality
standards appropriate to their intended use to
insure consumer’s health and benefit”
What do the “Guidelines Cover”
Comparison of Regulations
US EU ASEAN
Topic
Introduction X X X
Quality System X X X
Personnel X X X
Training X X X
Premises X X X
Equipment X X X
Sanitation/Hygiene X X X
Production/Manufacturing X X X
Purchasing X
Quality Management X
Quality Control X X X
Documentation X X X
Out of Spec Result Handling X
Labeling X X
Internal Audits X X
Storage X X
Contract Manufacturing X X
and Analysis
Complaints X X
Subcontracted Manufacturing X
Sample Retention X X
Recalls X
Shipping Traceability X
Glossary X X
Comparison of GMPS
US FDA, WHO & EU
• Responsibility for Quality
– FDA – the QC unit is responsible for quality
– WHO & EU – define both separate and joint responsibilities
for the QC unit and production management
• Personnel Qualifications
– FDA – education, knowledge, skills or experience needed for
specific job functions are not defined
– WHO & EU – provide such definitions & requirements
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Harmonization
International Cooperation on Cosmetic Regulation
(US, European Union, Canada, Japan)
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Definition of cGMP
“The minimum current good manufacturing practice for
methods to be used in, and the facilities or controls to
be used for, the manufacture, processing, packing or
holding of a drug to assure that such drug meets the
requirements of the act as to safety, and has the
identity and strength and meets the quality and purity
characteristics that it purports or is represented to
possess.”
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Does it apply to cosmetics
too?
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Yes, cosmetics too.
“These regulations clearly apply to all drugs whether or
not they are characterized as old drugs, new drugs,
investigational drugs, or ingredients of drugs, devices
or cosmetics.”
SOURCE: Good Manufacturing Practices for Pharmaceuticals 4th Ed,
Willig & Stoker, Preface pp III-IV.
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FDA Definitions
• Cosmetics - cleanse and beautify the body; not including
soaps (alkali salts of fatty acids).
DO NOT REQUIRE PRE-MARKET APPROVAL BY
THE FDA.
However, color additives must be preapproved!
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OTC Drug vs. Cosmetic
OTC Drug Cosmetic
• Pre-market approval or • Pre-market approval not
USP monograph required required
• Safety & efficacy must be • No pre-market clearance of
cleared product or ingredient claims,
• Subject to cGMP safety or efficacy
• Must not be adulterated • Must not be adulterated or
or misbranded misbranded
• Establishments & • Establishment & product
products must be registration not mandatory
registered • No prescription required
• No prescription required • Adverse event reporting is
• Symptom relief not required (yet)
• Cleansing, beautifying, or
altering the appearance
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FDA Focus
• Office of Cosmetics & Colors (OCAC) / Center for
Food Safety and Nutrition (CFSAN) (Dec 6, 2006)
– Microbial contamination
– Illegal color additive use
– Bovine Spongiform Encephalopathy (BSE)
– Bioterrorism/Counterterrorism (BT/CT)
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FDA
Cosmetics Mission Statement
“ . . . Protect the public health by
ensuring that cosmetics are
safe and properly labeled . . .”
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The Focus of the FDA’s cGMPs
- Annual Product Reviews - Salvage / Returns
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Cosmetic Safety, as per the FDA
• Can not contain any of the restricted ingredients.
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Adulterated (Sec. 601)
• Injurious to users under conditions of customary use
because it contains, or its container is composed of, a
potentially harmful substance, chemical contaminant or
prohibited ingredient
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Prohibited Cosmetic Ingredients
1. Hexachlorophene (21 CFR 250.250)
2. Mercury Compounds (21 CFR 700.13)
3. Chlorofluorocarbon Propellants (21 CFR 700.23 and
2.125)
5. Acetyl ethyl tetramethyl tetralin (AETT)
6. 6-Methylcoumarin (6-MC)
7. Musk Ambrette
8. Nitrosamines
9. Dioxane
10. Certain cattle materials
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Restricted Cosmetic Ingredients
(permissible as unintentional contaminants)
1. Bithionol
2. Halogenated Salicylanilides
3. Chloroform
4. Vinyl chloride
5. Zirconium containing complexes in aerosol
cosmetic products
6. Methylene chloride
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Other FDA positions . . .
• Natural
– Not defined in FD&C Act or in FDA regulations for
cosmetics
– May be defined for other commodities as ‘minimal
processing’, ‘semi-synthetic’, ‘nature-identical’, etc.
• Organic
– Not defined in FD&C Act or in FDA regulations for
cosmetics
– Defined by USDA for agricultural commodities &
ingredients
• Cosmeceutical
– The FDA does not recognize this term which is
analogous to Japan’s “quasi-drug” category.
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GMP for Cosmetics
“Although there are no good manufacturing
practice (GMP) regulations for cosmetics, we
do have Good Manufacturing Practice
Guidelines (Inspection Checklist). Failure to
adhere to GMP may result in an adulterated
or misbranded product.”
http://www.fda.gov/Cosmetics/GuidanceComplianceRegulatoryIn
formation/ComplianceEnforcement/ucm136455.htm
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We are a “self-regulated” industry . . .
REMEMBER
While we may be “self-regulated”
the FDA has ultimate authority over cosmetics too!
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