ACI's Legal, Regulatory and Compliance Forum on Cosmetics

ACI’s Legal, Regulatory and Compliance Forum on Cosmetics February 20-21, 2014

Designing a Practical, Compliance- Friendly Quality System to Meet cGMPs for Cosmetic Products

John C. (Jack) Garvey, Esq. Principal / Chief Executive Officer Compliance Architects LLC www.compliancearchitects.com Speaker Introduction

Experience Summary:  Almost 30 years of experience in FDA-regulated operations, quality, compliance, regulatory & law  Founder & Principal, Compliance Architects LLC

Education: Chemical Engineer / Attorney

Companies worked in and for: Focus areas:  Johnson & Johnson (PSGA, J&J  Enforcement remediation Consumer Products, Neutrogena, (483s, WLs, Import Detention, etc.) OCD, Ethicon-Endo, OraPharma)  Quality Systems Architectures  Ciba-Geigy (Novartis)  Corporate Compliance  BASF Corporation  HACCP / Process mapping & risk analysis  CR Bard  CAPA program development & drafting  Accenture/BMS  Computer-based systems, enterprise risk  Ayerst (Wyeth) management & quality operations  Aventis-Behring  Inspection readiness and preparation  Philips Healthcare  Writing for Compliance®  Various Others IP and Logo Use Disclaimer

Company logos and/or other brand names, trademarks, etc. used within this presentation are the respective intellectual property of individual companies, and are used strictly for the benefit of this industry audience.

It is believed the use in this context is considered fair or nominative use of a logo / trademark for purposes of description and identification.

Compliance Architects LLC makes no claim whatsoever to any trademark or other intellectual property referenced or identified within this presentation. Background  Design Coverage / Agenda

Background Design

© 2014 Compliance Architects LLC Background  Design Recap of Ann’s Legal / Regulatory Summary • Original guidance was a basic checklist • Despite regulation rigor – FDA enforces under adulteration theories • New guidance expands to require increased documentation, audits, and principles from ISO 22716 • FDA has been and will continue to enforce against companies in this space • With new guidance comes new expectations, and likely, increased enforcement

Background Design

Pharmaceuticals Key Concept: Differentiate Formulation Impacts from Delivery Impacts

Formulation / Ingredients Primary Labeling / Analogous Packaging IFU Structural Elements: “Actives”

Delivery / Secondary “Dosage Packaging Forms”

Key Differences: • No pharmacological effect; • Nothing affecting structure/function of body; • No impact on disease, whether preventive, curative or mitigating.

Important: SPF = Pharmaceutical

Other Classification Comparisons: • A suntan product is a cosmetic, but a sunscreen product is a drug. • A deodorant is a cosmetic, but an antiperspirant is a drug. • A shampoo is a cosmetic, but an antidandruff shampoo is a drug. • A toothpaste is a cosmetic, but an anti-cavity toothpaste is a drug. • A skin exfoliant is a cosmetic, but a skin peel is a drug. • A mouthwash is a cosmetic, but an anti-gingivitis mouthwash is a drug. • A hair bulking product is a cosmetic, but a hair growth product is a drug. • A skin product to hide acne is a cosmetic, but an anti-acne product is a drug. • A skin moisturizer is a cosmetic, but a wrinkle remover is a drug. • A lip softener is a cosmetic, but a product for chapped lips is a drug.

Cosmetics  Pharmaceuticals

Other Cosmetics Other Topical OTCs Solid Oral Injectables/ with Traditional Cosmetics (Acne, Dosage/ Parenterals/ Sunscreens Form RX Dandruff, Liquid OTCs Opthalmics (SPF) Products etc.)

INCREASING ENFORCEMENT RIGOR

Formulation Primary Analogous / Ingredients Packaging Structural Elements:

Delivery / Application Structures

Key Similarities: • No pharmacological effect; • Nothing affecting structure/function of body (exc. Dietary supplements); • No impact on disease, whether preventive, curative or mitigating.

• Documentation • Prohibited and • Records Restricted Cosmetic • Buildings and Ingredients Facilities • Production • Equipment • Laboratory Controls • Personnel • Internal Audit • Raw Materials • Complaints, Adverse Events, • Water and Recalls • Color Additives © 2014 Compliance Architects LLC Background  Design New Guidance: Visually

PHARMA GMPS NEW COSMETIC GUIDANCE ISO 22716 Organization & Personnel Documentation Personnel Buildings & Facilities Records Premises Equipment Buildings and Facilities Equipment Control of Components, Equipment Raw Materials & Packaging Drug Product Containers Personnel Materials & closures Raw Materials Production Production & Process Controls Water Finished Product Packaging & Label Control Color Additives QC Laboratory Holding & Distribution Prohibited and Restricted Treatment of Out-Of-Spec Laboratory Controls Cosmetic Ingredients Product Records & Reports Production Wastes Returned / Salvaged Laboratory Controls Subcontracting Drug Products Internal Audit Deviations Complaints, Adverse Events, Complaints & Recalls and Recalls Change Control Internal Audit Documentation

So given the foregoing – how should we approach designing and implementing a quality system to meet the new guidance and FDA expectations?

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2 of 2 For a full-page .PDF copy of this slide, email me at: [email protected] or visit www.compliancearchitects.com/2014/acigmp

REMEMBER: SYSTEMS ≠ CONTROL

Delivery / HACCP Quality Plan Formulati IFU / “Dosing” on Design Labeling Control of Productio Design for Design for for Design for Supply Hazard Critical n & Simplicity, Manufact Effectiven Simplicity Control Control Control Process Safety & urability ess / & Points Controls Effectiven Safety Utility ess

The Quality System

© 2014 Compliance Architects LLC Background  Design Consider the Business Overlay • Type of organization • Vertically / horizontally integrated? Virtual? • Regional / global? • Commercialization activity • Stable portfolio? • New product commercialization churn? • Platform technologies? • Financial Drivers • Margin sensitive? • Prefer outsourcing?

Next Steps / Path Forward

© 2014 Compliance Architects LLC Background  Design Path Forward • Evaluate your • Remediation plan business model • Phased • Evaluate your implementation product risks, field • Periodic suitability history, and evaluation enforcement history • Evaluate your current systems against current expectations • Gap analysis

John C. (Jack) Garvey, Esq. Principal Compliance Architects LLC www.compliancearchitects.com [email protected] 888-REG-XPRT (888-734-9778)

For a free White Paper on designing a Quality System for the new Cosmetics Guidance, visit: www.compliancearchitects.com/2014/acigmp