Implementation of GMP’s for
Cosmetics in a Changing Global
Environment
Presented to the
New England Chapter
Society of Cosmetic Chemists
April 5, 2012
by
Joseph Albanese
3V, Inc.
and
Karl F. Popp, R. Ph.
KPOPP Consulting, LLC
Course Goals
• Provide an Overview of US, EU, and ASEAN GMP
Regulations affecting Cosmetics
• Discuss Quality Systems
• Review Procedures for Writing, Issuance,
maintenance and Implementation of SOPs
• Show How GMPs affect Product Processing
– Raw Materials
– Manufacturing and Packaging Batch Records
– Equipment Cleaning Labeling and Storage
– QC Testing
• Managing Water Systems
• Auditing for Compliance
• Introduce Process and Cleaning Validation
Why are there GMPs?
• Responsibilities
– Corporate
– Personal
– Legal
• FDA
• European Regulations
• Association of Southeast Asian Nations
• Importation
• Export
• Fraud
• SOMEONE GOT HURT !
Short Story on GMPs
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Prevent contamination
Prevent mix ups and errors
Instill process controls
Insure product quality
Save everyone money
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
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Topic
Introduction
Quality System
Personnel
Training
Premises
Equipment
Sanitation/Hygiene
Production/Manufacturing
Purchasing
Quality Management
Quality Control
Documentation
Out of Spec Result Handling
Labeling
Internal Audits
Storage
Contract Manufacturing
and Analysis
Complaints
Subcontracted Manufacturing
Sample Retention
Recalls
Shipping Traceability
Glossary
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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
• Production & Process Controls
– FDA – focuses on levels of approval
– ICH – focuses on stability requirements
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Harmonization
International Cooperation on Cosmetic Regulation
(US, European Union, Canada, Japan)
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Good manufacturing practices
Ingredient labeling / INCI names
Nanotechnology
Market surveillance
Authorized substances
Animal testing and alternative methods
Sunscreen regulations and test methods
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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.”
- Title 21 Code of Federal Regulations (CFR),
Part 210.1
What is “current” and “good”?
• Feasible for manufacturers to implement
• Not just for DRUGS
• Contributes to ensuring the safety, quality, or purity of the
drug product
• The value of the contribution exceeds the cost or other
burdens of implementation
• It does not have to be the most prevalent practice in the
industry
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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.
Sidney H. Willig - Drug Law Unit Temple University
James R. Stoker - Legal Dept. Sterling Drug
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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!
• Drugs – alter the structure or function of the body.
Intended to diagnose, treat, care, mitigate or prevent
disease.
DO REQUIRE PRE-MARKET APPROVAL BY THE
FDA.
• Both – a.k.a. “OTC Drugs” shampoos that are also
antidandruff, deodorants that are also antiperspirants,
dentifrice with fluoride, creams & lotions with
sunscreens, antibacterial cleansers
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OTC Drug vs. Cosmetic
OTC Drug
Cosmetic
• Pre-market approval or
USP monograph required
• Safety & efficacy must be
cleared
• Subject to cGMP
• Must not be adulterated
or misbranded
• Establishments &
products must be
registered
• No prescription required
• Symptom relief
• Pre-market approval not
required
• No pre-market clearance of
product or ingredient claims,
safety or efficacy
• Must not be adulterated or
misbranded
• Establishment & product
registration not mandatory
• No prescription required
• Adverse event reporting is
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)
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Microbial contamination
Illegal color additive use
Bovine Spongiform Encephalopathy (BSE)
Bioterrorism/Counterterrorism (BT/CT)
• Center for Drug Evaluation & Research (CDER)
– Dermatology
– OTC Products
– Compliance
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FDA
Cosmetics Mission Statement
“ . . . Protect the public health by
ensuring that cosmetics are
safe and properly labeled . . .”
- Food and Drug Administration
Modernization Act (FDAMA) of 1997, Sec. 406(b)(2)(D)
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The Focus of the FDA’s cGMPs
- Annual Product Reviews
- Salvage / Returns
- Consumer Complaint
Reviews
- Rejects
- Stability Failures
- OOS / Failure Investigations
- Quarantined Products
- Change Control
- Validation
- Continuous Improvement
- Reprocessing
- Training / Qualification
of Employees
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You’re not likely to fly under
the radar screen
• “Interstate commerce” means between
any State, Territory or the District of
Columbia. It applies to all steps in a
product's manufacture, packaging, and
distribution.
• “Commercial distribution” means
annual gross sales in excess of $1,000
for that product.
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Cosmetic Safety, as per the FDA
• Can not contain any of the restricted ingredients.
• Cosmetic firms must substantiate the safety of their
products before marketing them.
• If safety is not substantiated the following warning must
be on the label or the product is misbranded:
– WARNING- The safety of this product has not
been determined.
• Product recalls of hazardous cosmetics is voluntary.
– FDA works with the courts to remove adulterated
and/or misbranded cosmetics from the market
– Restraining orders, product seizure, criminal
prosecution of firms and individuals are all possible.
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Title 21, CFR for Cosmetic Products
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21 CFR PART 1 - General enforcement regulations
21 CFR Part 2 - General administrative rulings & decisions
21 CFR Part 20 - Public Information
21 CFR Part 250 - Requirements for drugs & cosmetics
21 CFR SUBCHAPTER G – COSMETICS
21 CFR PART 700 – GENERAL
Subpart A – General Provisions
Subpart B – Requirements for Specific Cosmetic Products
21 CFR PART 701 – COSMETIC LABELING,
Subpart A – General Provisions
Subpart B – Packaging
Subpart C – Labeling of specific ingredients
21 CFR PART 710 – Voluntary registration of cosmetic product
establishments
21 CFR PART 720 Voluntary filing of cosmetic product
ingredients & cosmetic raw material composition statements
21 CFR PART 740 – Cosmetic Product Warning Statements
21 CFR PART 820 – Quality Systems regulations
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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
• It contains filth and/or pathogenic bacteria
• It contains a non-permitted or in some instance noncertified, color additive
• It is manufactured or held under unsanitary conditions
whereby it may have become injurious to users or
contaminated by filth
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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
Organic dyes or pigments require pre-market approval
and must be certified by the FDA before use.
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Misbranded (Sec. 602)
• Failure to comply with the Fair Packaging & Labeling Act
of 1967
• Failure to comply with the Poison Prevention Packaging
Act of 1970
• Failure to state prominently and conspicuously any
information required by the FD&C Act
• False or misleading labeling
• Misleading container presentation or fill
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Restricted Cosmetic Ingredients
(permissible as unintentional contaminants)
1.
2.
3.
4.
5.
Bithionol
Halogenated Salicylanilides
Chloroform
Vinyl chloride
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 . . .
Consumer Commitment Code (2007)
•Cosmetic Ingredient Review Expert Panel
•Voluntary Cosmetic Reporting Program
•Report Adverse Experience to the FDA
•Maintain Safety Information Summary
REMEMBER
While we may be “self-regulated”
the FDA has ultimate authority over cosmetics too!
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