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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.

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implementation of gmp s for cosmetics in a changing global environment
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
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
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
Short Story on GMPs
  • Prevent contamination
  • Prevent mix ups and errors
  • Instill process controls
  • Insure product quality
  • Save everyone money

S A F E T Y

basic rule of thumb
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
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 regulations1
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
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 regulations2
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”
comparison of gmps us fda who eu
Comparison of GMPSUS 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
HarmonizationInternational Cooperation on Cosmetic Regulation (US, European Union, Canada, Japan)

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
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 puritycharacteristics that it purports or is represented to possess.”

- Title 21 Code of Federal Regulations (CFR), Part 210.1

what is current and good
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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yes cosmetics too
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
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 vs. Cosmetic

OTC Drug

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

Cosmetic

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
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)

Center for Drug Evaluation & Research (CDER)

Dermatology

OTC Products

Compliance

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fda cosmetics mission statement
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
The Focus of the FDA’s cGMPs

Annual Product Reviews

Consumer Complaint Reviews

OOS / Failure Investigations

Change Control

Continuous Improvement

Reprocessing

Salvage / Returns

Rejects

Stability Failures

Quarantined Products

Validation

Training / Qualification of Employees

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you re not likely to fly under the radar screen
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
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.

23

title 21 cfr for cosmetic products
Title 21, CFR for Cosmetic Products

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 ProvisionsSubpart B – Requirements for Specific Cosmetic Products

21 CFR PART 701 – COSMETIC LABELING,

Subpart A – General ProvisionsSubpart B – PackagingSubpart 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
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 non-certified, 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
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
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
Restricted Cosmetic Ingredients(permissible as unintentional contaminants)

Bithionol

Halogenated Salicylanilides

Chloroform

Vinyl chloride

Zirconium containing complexes in aerosol cosmetic products

Methylene chloride

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other fda positions
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.

29

gmp for cosmetics
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/GuidanceComplianceRegulatoryInformation/ComplianceEnforcement/ucm136455.htm

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we are a self regulated industry
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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