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Jennifer Noonan Sheffield

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Page 1: Jennifer Noonan Sheffield
Page 2: Jennifer Noonan Sheffield

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

Page 3: Jennifer Noonan Sheffield

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

Page 4: Jennifer Noonan Sheffield

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

Page 5: Jennifer Noonan Sheffield

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

Page 6: Jennifer Noonan Sheffield

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 AntibioticTriple Antibiotic with Pramoxine

BacitracinDiphenhydramine

HydrocortisoneMenthol Muscle Rub

Capsaicin Muscle RubZinc Oxide

Hemorrhoid ReliefClotrimazole

Povidone IodineTolnaftate

Benzoyl PeroxidePetrolatum with A&D

Personal LubricantWarming Lubricant

Fluoride ToothpastesWhitening Gels

Denture AdhesivesBaby teething Gel

Adult Oral Gel

Page 7: Jennifer Noonan Sheffield

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

Page 8: Jennifer Noonan Sheffield

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.

 

Consistency The 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

Page 9: Jennifer Noonan Sheffield

Quality Control30 professionals and chemists degreed 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

Page 10: Jennifer Noonan Sheffield

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

Page 11: Jennifer Noonan Sheffield

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

Page 12: Jennifer Noonan Sheffield

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

Page 13: Jennifer Noonan Sheffield

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

Page 14: Jennifer Noonan Sheffield

Product Customization

Deliveringa Catalog of Formulations

and Current SKU’s

Jennifer Noonan Sheffield PPT

Page 15: Jennifer Noonan Sheffield

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

Page 16: Jennifer Noonan Sheffield

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

Page 17: Jennifer Noonan Sheffield

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

Page 18: Jennifer Noonan Sheffield

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