Jennifer Noonan Sheffield
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Jennifer Noonan Sheffield

Jennifer Noonan Sheffield

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Jennifer Noonan Sheffield Presentation Transcript

  • 1.
  • 2. Sheffield Pharmaceuticals
    Adaptable · Integrated · Scalable
    Providing Value Chain Solutions for the OTC Health Care and Personal Care Markets
    We are a company of committed, team-oriented professionals focused on providing the highest quality service and products to our customers in accordance with FDA cGMP regulations and procedures
    Jennifer Noonan Sheffield PPT
  • 3. Background and History
    Founded by Dr. W.W. Sheffield, inventor of crème dentifrice and tubed toothpaste
    159 years continuous operation in CT Historic Landmark-designated location
    Core focus on OTC pharmaceutical and HBA preparations
    Purchased by Faria family in 1986
    20+ years pharmaceutical development and manufacturing
    150 employees, average tenure 5+ years
    Jennifer Noonan Sheffield PPT
  • 4. The Total Value Chain Solution
    Turnkey CMO Delivering Project Management and Support
    Quality Assurance and Regulatory Guidance
    Quality Control, Stability, and Production
    Research & Development Laboratory
    Graphics Department Offering Development and Compliance Review
    Purchasing Department for International Best-Cost Sourcing
    Jennifer Noonan Sheffield PPT
  • 5. Production Specialization
    Offering Customized Manufacturing Solutions
    Compounding in Continuous-Improvement Suites
    On-site Machine Shop for Custom Tooling
    100% Off-Grid Uninterrupted Power Supply
    Manufacturing on Customizable On-demand Filling Lines
    Jennifer Noonan Sheffield PPT
  • 6. Prime Vendor Capabilities
    Partnering with distributors to reduce touch-points and carry-through
    Single-market focus specializing in topical OTC and Apothecary formulations
     
    Jennifer Noonan Sheffield PPT
    Triple Antibiotic
    Triple Antibiotic with Pramoxine
    Bacitracin
    Diphenhydramine
    Hydrocortisone
    Menthol Muscle Rub
    Capsaicin Muscle Rub
    Zinc Oxide
    Hemorrhoid Relief
    Clotrimazole
    Povidone Iodine
    Tolnaftate
    Benzoyl Peroxide
    Petrolatum with A&D
    Personal Lubricant
    Warming Lubricant
    Fluoride Toothpastes
    Whitening Gels
    Denture Adhesives
    Baby teething Gel
    Adult Oral Gel
  • 7. Contract Packaging Manufacturer
    Turnkey Product Solutions from R&D to Full-scale Production
    Staffed by industry veterans, from custom-machining to unique filling options, we will meet your development and production needs
    Relying heavily on team communication, Sheffield’s Matrixed Project Management platform assures continuity and immediate response
    Scientific methods and experience join with responsiveness and innovation to provide support from inception to final delivery
    Jennifer Noonan Sheffield PPT
  • 8. Outsource Management
    Adaptability Our industry professionals can jump in at any point of your product’s development cycle - From ideation and bench top development, through pilot and accelerated stability studies, Sheffield adds value and delivers.
     
    ConsistencyThe average tenure of our professional staff is 6+ years, with degrees in Industrial and Organic Chemistry, Microbiology and Clinical medical degrees, and specializations in cosmetic chemistry, clinical testing, and compliance, Sheffield is a dependable, partner for years to come.
    Flexibility Proprietary product development, validated method development, stability, Phase I-III compounding and manufacturing, bulk and finished goods, Sheffield will work to custom-tailor our capabilities to your project requirements.
    Jennifer Noonan Sheffield PPT
  • 9. Quality Control
    30 professionals and chemistsdegreed in Industrial, Cosmetic, and Organic Chemistry
    In-house services include
    Process,Product, and Packaging Validations
    Equipment IQ, OQ, PQ testing
    Blend uniformity
    Validated Methods for Phase I-III manufacturing
    Stability testing and assessment
    USP micro limit testing for raws and finished products
    Analytical services for raws and finished products
    Compatibility testing
    Chromatography
    USP Antibiotic testing
    Jennifer Noonan Sheffield PPT
  • 10. Compliance and Regulatory Affairs
    Sheffield’s QA Department develops and refines cGMP practices, guiding customers through monograph and compliance standards.
    Annual STR Laboratories Gold Star Certification
    QA Continuous Improvement programs,
    with bi-annual procedural review
    Regulatory FDA/ICH guidance
    Monograph compliance strategies
    Formulation development
    Export documentation to 80+ countries
    Jennifer Noonan Sheffield PPT
  • 11. Research and Development
    The primary scientist assigned will see your project through to completion
    Formulation development
    Bench and prototype sampling
    Pilot to small scale commercial batching
    Reverse engineering
    Regulatory monograph guidance
    Jennifer Noonan Sheffield PPT
  • 12. Compounding Overview
    Climate-controlled 200 ton capacity raw materials storage
    10,000 gallon sorbitol, glycerin and petrolatum tanks on site
    12,000 liter stainless steel deionized water holding tank
    Environmentally controlled, self-contained compounding suites
    800 liter mixers with heating/cooling: 10° to 100°C
    7 – Compounding fill lines
    5 - Nauta mixers
    2 - Blade stator mixing tanks
    6-Versators, 50 l/m capacity
    Jennifer Noonan Sheffield PPT
  • 13. Manufacturing Capabilities
    3-Collapsible Tube Filling TGM Machines
    13mm to 50mm diameter and 50mm to 200mm length
    Dosing from 10ml to 200ml
    Heated / chilled product hoppers
    2- High Speed Comadis CD180 Fillers
    Aluminum, laminate, polythene and polyfoil tubes
    Bottle and Jar Filling
    Dosing from 25 to 540ml
    Induction sealing/automatic capping
    Packet Filling
    Dosing from 1-28ml
    Custom Case Labeling
    Display, Inner Case, Gift Pack
    Jennifer Noonan Sheffield PPT
  • 14. Product Customization
    Jennifer Noonan Sheffield PPT
  • 15. Supply Chain / Logistics
    Monthly S&OP calls to review results and opportunities
    Dedicated project manager to support customer and production teams
    Complex global supply chain management experience
    Procurement specialists to source chemicals & components
    Aggressive cost improvement programs
    Regular “Key Supplier” business reviews
    Jennifer Noonan Sheffield PPT
  • 16. Green Initiatives
     
    Facility-wide motion-activated fluorescent lighting
    Dedicated recycling program for waste paper, cardboard and discontinued components
    First manufacturing facility in US to approach NPA for process certification
    Reducing waste thru electronic posting of inter-company information
    4-day factory week to limit energy consumption and commuting
    Smoke-free facility
     
    Jennifer Noonan Sheffield PPT
  • 17. Sustainability
    Sustainability Product Index and Eco-label Plan co-packager
    100% off-grid energy co-generation
    Developing energy cost, plant emission, material sourcing
    Partnering to establish global social compliance matrices
    Thermal capture to generate hot water and facility heating
    Dedicated recycling program for waste paper,
    cardboard and discontinued components
    Jennifer Noonan Sheffield PPT
  • 18. Milestones
    Double-digit growth for 3rd consecutive year
    Continuous Improvement
    Installation of state-of-the -art variable humidity25 degree and 40 degree stability chambers
    Remodeling compounding chambers with seamless composite walls, ceilings, and floors
    Facilities improvement campaign to on-board additional manufacturing capabilities
    Product Development
    68 new Products launched in 2008
    2006 to curren
    30 National Brand Equivalent OTC and HBA introductions
    2,500 SKU formulations in R&D
    109 Products incepted Pilot and Stability in 2008
    Jennifer Noonan Sheffield PPT
  • 19. Summary
    Sheffield Pharmaceuticals is a leader in the development of topical API and cosmetic formulations.
    Total turnkey services including formulation development, GMP manufacturing, analytical methods development, stability testing, manufacturing, and shipping.
    We provide world-class technical support, source the highest quality components, and employ the most efficient use of time and materials to control costs.
    Total solution to your development, design, and manufacturing, needs.
    Custom-tailored project management for rapid delivery, high quality, best-cost models.
    Jennifer Noonan Sheffield PPT