Jennifer Noonan Sheffield


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Jennifer Noonan Sheffield

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Jennifer Noonan Sheffield

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