TESTIMONIAL: Congratulations! Our company s EID Incoming Inspection of AMRESCO-provided products
|
|
- Gwendoline Norman
- 7 years ago
- Views:
Transcription
1 custom solutions With markets changing so rapidly, AMRESCO is on the front line bringing new technologies and processes so we can deliver solutions that solve our customers problems.
2 TESTIMONIAL: Congratulations! Our company s EID Incoming Inspection of AMRESCO-provided products will be waived. This is a direct result of your commitment to providing a superior quality product, as indicated by our inspection data. It also affirms our high level of confidence in AMRESCO S ability to continue providing 100% conforming products. We recognize the effort that went into attaining this status and appreciate your continued commitment to excellence on our behalf.
3 High Purity Chemicals pure QUALITY IN ACTION MAJOR PRODUCT GROUPS Agaroses & Acrylamides Amino Acids Antibiotics Antimycotics Biological Compounds Buffers Carbohydrates Chaotrophic Agents Chelating Agents Detergents Dyes/Stains Enzymes Media Phenols/Organics Preservatives Reagents Reducing Agents Salts Substrates Sugars AMRESCO is one of the world s leading manufacturers of fine chemicals, biochemicals and reagents, distributed directly under the AMRESCO brand or private labeled for large global leaders. Purity is our priority, and AMRESCO assures that the highest industry standards are achieved through rigorous ISO standards and FDA regulation. Cost and material efficiency is essential in achieving competitive advantage in today s challenging market. That s why we provide our products in the exact quantity, formulation, grades and packaging our customers need and want. INDUSTRY INSIGHTS WE HEAR THAT... With new life science market opportunity comes increased risk and regulation. Whether supplying enterprising new start-ups or large international manufacturers, quality is paramount, along with the ability to provide all relevant documentation. Customers tell us they need a provider with expansive product knowledge and flexibility in formulation, packaging, logistics and competitive pricing. Extensive depth in our raw material supply chain assures quality, traceability and on time delivery AMRESCO S Product Design Group consults with customers for custom formulations, testing and validation methods solutions Profitability and operation efficiency is achieved through custom packaging and inventory management
4 Custom Specialty Manufacturing precise INNOVATION IN FOCUS With rapid advancements and changes in the life sciences markets, AMRESCO s ongoing investment in advanced precision manufacturing technology positions us well to meet our customers complex production requirements. So does the investment in our human capital our people. We work expertly and efficiently on behalf of our customers and mutually share in their success. From start-ups to multi-national corporations, we look to bring value in the way that benefits each customer best. INDUSTRY INSIGHTS WE HEAR THAT... Life science companies today need partners with operational flexibility coupled with uncompromising and consistent quality. With growth and profitability concerns, companies are evaluating internal limitations and looking to forge strong service partnerships to increase capacity, reduce hazardous material handling, contain cost, expand market opportunity and conserve capital. AMRESCO is structured to deliver comprehensive scalability and customization for production, packaging and deliverability Our experienced project management and production teams can provide product development and co-development support or manufacture according to customer specifications AMRESCO S capital investment in infrastructure, technology and capabilities, along with continual process improvement, is designed to keep us moving in line with and ahead of market needs CUSTOM SERVICES Custom Contract Manufacturing OEM Manufacturing Liquid Manufacturing Powder Manufacturing Specialty Manufacturing Product Design & Development Custom Packaging Label Control & Management Hazardous Material Production Handling & Transportation Validation & Qualification Expertise Regulatory Expertise & Alignment 372
5 Manufacturing Services CUSTOM MANUFACTURING OEM Manufacturing FDA QSR Compliant Facilities Custom Protocols & Specifications Lean Production Processes & Principles Scale-Up from Bench Scale to Large Lot Sizes Ability to Manufacture Complex Materials Formulation Development & Execution Environmentally Controlled Facilities Segregated Facilities for Sensitive Products SPECIALTY MANUFACTURING Tableting Lyophilization Recrystallization Slurry, Emulsion & Viscous Material Handling Dye Liquid & Powder Compounding Gamma Irradiation & Autoclave Sterilization Specialty Filtration Processes Molecular Material Handling Dye Handling & Compounding LIQUID MANUFACTURING Scalable Lot Sizes: Bench Scale to Thousands of Liters Per Lot Sensitive Materials Requiring Environmental Controls RNase, DNase & Protease Free Reagents Low Endotoxin Reagents Aseptic Reagents Precision & Tight Tolerance Requirements Molecular Materials-RNA, DNA, Proteins Enzyme & Active Ingredient Reagents Hazardous Materials & Reagents pricing and discounts. POWDER MANUFACTURING Scalable Lot Sizes: Bench Scale to Metric Tons Complex Multi-Component Compounding Homogenous Complex Blends Sensitive Materials Requiring Environmental Controls Segregated Handling for Non-Animal Origin Antibiotics Hygroscopic Materials Particle Size Control / Exclusion Particle Size Reduction / Milling Low Endotoxin Products Hazardous Product Handling Dye Handling & Compounding
6 Strategic Services performance POSSIBILITIES DELIVERED A promise is a promise is a promise. It s performance that delivers on a promise that is the measure of success. Performance driven by deep industry knowledge and a strong extensive track record over time. More and more, companies are turning to AMRESCO for solutions to their challenges, including infrastructure support, risk mitigation, start-up or enterprise support, profitability and growth initiatives. They need a partner that stands with them and they want success. We want that, too. INDUSTRY INSIGHTS WE HEAR THAT... Increasing market pressures are challenging life sciences companies to address infrastructure inefficiencies, production capacity, logistics and inventory management, as well as mitigate tax and insurance implications, meet compliance and quality standards, maintain competitive advantage, compress critical time to market performance and a growing host of critical considerations. STRATEGIC SERVICES Inventory Management Cost Improvements Product Transition and Integration Capacity Management Global Logistics Supply Chain Management Pack and Hold Options Process Improvement Warehousing Drop Shipment Capabilities Label Control and Management Documentation Our Product Design and Engineering Team works closely with each customer to develop the unique design and production programs that help them focus on the future, not production limitations. Our Strategic Services Team are specialists at assessing operational and process inefficiencies, providing invaluable support and expertise in increasing performance, service and profitability
7 Custom Packaging and Dosing Capabilities CUSTOM PACKAGING & DOSING CAPABILITIES Private Label / OEM Packaging Expertise Reduce Lot Tails with Custom Raw Material Packs Customer Packaging Scale-Up from Small to Large Lot Sizes Automated Production Processes Environmentally Controlled Capabilities Segregated Facilities for Sensitive Products: Antibiotics Non-Animal Origin Materials Hazardous Materials Hygroscopic Materials Light Sensitive Materials FLEXIBILITY IN PACKAGING TYPES Bottles Drums Pails Vials Ampoules Tablet Strip Packing Pouches Bladder Bags/Totes Serum Vials & Stoppers Kits Unique Custom Packaging POWDER PACKAGING Precision Powder Dosing Milligram Quantities Humidity Controlled Handling Light Sensitive Material Handling Handling under Inert Gas High Throughput, Semi-automated Powder Dosing LIQUID PACKAGING Precision Liquid Dosing Microliter to Hundreds of Liters Unit Quantities High Throughput, Automated Liquid Dosing Aseptic Dosing Sterile Processing to USP Sterile Levels Tight Tolerance Dosing KIT ASSEMBLY Complete Traceability of Kit Components Flexibility & Customization in Kit Configuration Full Supply Chain Management Order Placement and Receiving
8 Supply Chain Management LABEL CONTROL AND MANAGEMENT Inventory of Label Stock Printing Capabilities Label Security & Reconciliation Flexible Label Styles, Shapes Customer Specific Labels LOGISTICS Worldwide Distribution Expertise Hazardous Material Shipping Expertise Temperature Sensitive Material Capabilities Drop Shipment Capabilities Certified & Trained Logistics Documentation Capabilities FULL SUPPLY CHAIN MANAGEMENT Reduce Material Receipt Cycle Times Maximize Warehouse Volumes Reduce On-Hand Inventory Pack & Hold Options Raw Material Procurement & Management Robust Supply Chain Management Includes Validated Secondary & Tertiary Supplies Lot Reserve Minimize Sampling of Batches & Incoming Inspection Drop Shipment Capabilities CASE STUDY THE VALUE OF RELATIONSHIP Trust takes time, along with performance, understanding and alignment. For several years, AMRESCO had called on this leading molecular diagnostic company and when their contract manufacturer did not pass the customer s audit, their upcoming product launch became a crisis. They needed a partner, one with advanced capabilities, supported by strong team relationships. AMRESCO moved through validation, then integration of its new aseptic precision automation system into the manufacturing process. We were also able to reduce their supplier base, manage their supply chain and provide them the freedom to focus on issues core to their platforms
9 Regulatory & Quality Systems Trust and performance are the key decision points for companies looking for their outsourcing partner. Quality is essential, as is uncompromised deliverability and repeatability. Documentation, labeling, testing and supply chain exposure assessment and management mitigates critical regulatory and compliance issues. Outsourcing quality control, certification and testing provides greater assurance in validations and audits. REGULATORY ALIGNMENT ISO 9001 Certified with Design Control ISO Certified with Design Control FDA QSR Compliant Facilities, Processes & Documentation FDA registered as a manufacturer of In Vitro Diagnostics and handler of pharmaceutical intermediates QUALITY MANAGEMENT SYSTEM Full Traceability Change Control FDA Level Document Control Environmentally Monitored Production Processes Environmentally Controlled Production & Warehouse Facilities Method, Product, Process Validation Corrective & Preventive Action System Continual Improvement System Non-Animal Origin (NAO) Control ANALYTICAL & CUSTOM QUALITY CONTROL SPECIFICATIONS Multi-compendial Testing Material Certification Sensitive Analytical Testing Chromatography ICP FTIR Titration Spectrophotometric Testing Bioburden Testing Endotoxin Testing Custom Functional & Performance Assays Material Origin Control Full Lot Traceability Products Tested & Retained
Manufacturing CUSTOM CHEMICALS AND SERVICES, SUPPORTING SCIENTIFIC ADVANCES FOR HUMAN HEALTH
Manufacturing CUSTOM CHEMICALS AND SERVICES, SUPPORTING SCIENTIFIC ADVANCES FOR HUMAN HEALTH VWR enables the advancement of science by providing high-quality chemicals and services, customized to your
More informationLiquids Suspensions Gels
Liquids Suspensions Gels EMCM: your product development and manufacturing partner Centre of excellence European Medical Contract Manufacturing (EMCM) is the centre of excellence in developing and manufacturing
More informationMeriCal Quality Profile
January 5, 2015 Dear Valued Customer, Since the implementation of new federal regulations, MeriCal Inc. has received a large volume of questionnaires and surveys regarding our services and procedures.
More informationNEW CHEMICAL ENTITIES
NEW CHEMICAL ENTITIES PIONEERING PARTNER FOR PEPTIDES With more than 40 years of expertise in peptide synthesis, a track record in process development, large-scale manufacturing and outstanding product
More informationQuality. Now Certified to ISO 9001:2008
Quality Now Certified to ISO 90012008 Quality Policy It is Peptides International's goal is to achieve complete customer satisfaction by addressing customer needs and delivering what we promise. The company
More informationC 5. chemical development contract research custom synthesis cgmp API manufacturing commercial production. Welcome to
C 5 chemical development contract research custom synthesis cgmp API manufacturing commercial production Welcome to ChemCon Company profile Company profile ChemCon offers outstanding chemical services
More informationAS9100 Quality Manual
Origination Date: August 14, 2009 Document Identifier: Quality Manual Revision Date: 8/5/2015 Revision Level: Q AS 9100 UNCONTROLLED IF PRINTED Page 1 of 17 1 Scope Advanced Companies (Advanced) has established
More informationSupplier Quality Agreements
Supplier Quality Agreements Dan O Leary CBA, CQA, CQE, CRE, SSBB, CIRM President Ombu Enterprises, LLC Dan@OmbuEnterprises.com www.ombuenterprises.com 603-209-0600 1 Speaker Biography Dan O Leary Dan O
More informationHEALTHCARE Single - Use Systems CONTRACT MANUFACTURING SOLUTIONS PARTNER
HEALTHCARE Single - Use Systems CONTRACT MANUFACTURING SOLUTIONS PARTNER ASI (A Part of Thermo Fisher Scientific) is dedicated to providing innovative and cost effective solutions to the Life Sciences
More informationQuality Management Systems Manual
Washington Division Quality Management Systems Manual ISO 13485:2003 DOCUMENT NUMBER 01-QM-MED REVISION LEVEL 01 PAGE 1 of 40 This manual describes the quality management systems structure at GM Nameplate
More informationTrack and trace solution for returnable asset management
Track and trace solution for returnable asset management An industry whitepaper 3960 Fabian Way Palo Alto, CA 94303 650-397- 2550 www.frequentz.com Copyright 2014 Frequentz. All rights reserved. Returnable
More informationFILTRATION SOLUTIONS PhARmAceUTIcAL manufacturing FILTRATION SPecIALISTS
FILTRATION SOLUTIONS Pharmaceutical Manufacturing filtration specialists Delivering quality filtration products As one of Europe s leading manufacturers of process filters, Amazon Filters is able to offer
More informationImpact of Formula-Based ERP Applications on Chemical Manufacturers
Impact of Formula-Based ERP Applications on Chemical Manufacturers Executive Summary Whether you re in the process of re-evaluating your existing ERP solution or looking to replace your spreadsheets, it
More informationDot Blot Analysis. Teacher s Guidebook. (Cat. # BE 502) think proteins! think G-Biosciences www.gbiosciences.com
PR110 G-Biosciences 1-800-628-7730 1-314-991-6034 technical@gbiosciences.com A Geno Technology, Inc. (USA) brand name Dot Blot Analysis Teacher s Guidebook (Cat. # BE 502) think proteins! think G-Biosciences
More informationUXC Eclipse + Microsoft Dynamics NAV for Life Sciences
UXC Eclipse + Microsoft Dynamics NAV for Life Sciences The foundation of the UXC Eclipse Life Science Solution is Microsoft Dynamics NAV, delivering with the industry expertise of UXC Eclipse and rigorous
More informationQualitative NIR Analysis for Ingredients in the Baking Industry
Overview The challenge to all baking companies in today s economy is to operate plants as efficiently as possible, with a focus on quality and keeping costs in check. With regulatory issues becoming more
More informationSingle or Multi-DC Network: Pros, Cons and Considerations
White Paper Single or Multi-DC Network: Pros, Cons and Considerations Companies need to factor in multiple details when choosing whether to operate from one or more distribution center. 2 Single or Multi-DC
More informationEnhanced Quality Product Documentation
Enhanced Quality Product Documentation PIPES, Disodium Salt PharmaGrade, Manufactured under appropriate controls for use as a raw material in pharma or biopharmaceutical production, Suitable for cell culture.
More informationMANAGING THE COMPLEXITIES OF GLOBAL PHARMACEUTICAL SOURCING
DPT Thought Leadership Issue 10 MANAGING THE COMPLEXITIES OF GLOBAL PHARMACEUTICAL SOURCING With the increased globalization and complexity of the pharmaceutical supply chain, managing the sourcing of
More informationBioprocessing Media and Buffers Grow with Us
Bioprocessing Media and Buffers Grow with Us Experience Highly experienced media on the selection of standard media as well as development This service packaging, documentation Leading position in single-use
More informationMark Rohlfing. Vice President of Operations Almac Clinical Services Souderton, Pennsylvania
Mark Rohlfing Vice President of Operations Almac Clinical Services Souderton, Pennsylvania Confidential Almac Group 2014 Who We Are Almac is a global drug development services provider. Our mission is
More informationBlood, Plasma, and Cellular Blood Components INTRODUCTION
Blood, Plasma, and Cellular Blood Components INTRODUCTION This chapter of the Guideline provides recommendations to Sponsors of Requests for Revision for new monographs for blood, plasma, and cellular
More informationSterile Cleanroom Management
Sterile Cleanroom Management Lynn Stanard, Sr. Quality Manager, Berkshire Corporation When manufacturing in an aseptic environment, it is critical to ensure that the various cleanroom consumables, such
More informationFueling your supply chain for global growth. UPS Aerospace Logistics Solutions
Fueling your supply chain for global growth UPS Aerospace Logistics Solutions Challenges facing the aerospace industry have never been greater. The demand for more fuel-efficient aircraft and an increasing
More informationAnnex 7 Guidelines on pre-approval inspections
World Health Organization WHO Technical Report Series, No. 902, 2002 Annex 7 Guidelines on pre-approval inspections 1. General 94 2. Glossary 94 3. Objectives 95 4. Priorities 96 5. Preparation for the
More informationINTRODUCTION: PURPOSE:
UMBRA CUSCINETTI, INC. 2916 100 th Street SW Everett, WA 98204-1340 USA 425-743-2577 FAX: 425-347-0682 Printed versions may not be the latest. Suppliers shall utilize the latest version which can be found
More informationKMS-Specialist & Customized Biosimilar Service
KMS-Specialist & Customized Biosimilar Service 1. Polyclonal Antibody Development Service KMS offering a variety of Polyclonal Antibody Services to fit your research and production needs. we develop polyclonal
More informationwhitepaper Impact of Formula- on Pharmaceutical Manufacturers www.aptean.com
whitepaper Impact of Formula- Based ERP Applications on Pharmaceutical Manufacturers WHITEPAPER Essentials for pharmaceutical manufacturers 2 about Whether you re in the process of re-evaluating your existing
More informationBeverage Solutions Delivered by Tectura
Beverage Solutions Delivered by Tectura Tectura Makes a Distinctive Difference for the Beverage Industry Beverage manufacturing requirements have become increasingly complex requiring quick visibility
More informationQuality Agreement Template
Quality Agreement Template Prepared by Dan O Leary Ombu Enterprises, LLC 3 Forest Ave. Swanzey, NH 03446 603-209-0600 This document is intended to form the basis for a Supplier Agreement. The document
More informationDraft guidance for registered pharmacies preparing unlicensed medicines
Draft guidance for registered pharmacies preparing unlicensed medicines January 2014 1 The General Pharmaceutical Council is the regulator for pharmacists, pharmacy technicians and registered pharmacies
More informationRisk Assessment of Outsourcing Pharmaceutical Packaging
Risk Assessment of Outsourcing Pharmaceutical Packaging Dr Afshin Hosseiny November 2004 Slide Number 1 11/04 Why Outsource? Technical requirements Capacity requirements Speed of Setting up Location -
More informationOvercoming Challenges in the Manufacturing of Pre-Filled Syringes. Farvea, a new comer in the PFS world PFS Tech 2016. June 2016 pharma@fareva.
Overcoming Challenges in the Manufacturing of Pre-Filled Syringes Farvea, a new comer in the PFS world PFS Tech 2016 June 2016 pharma@fareva.com Our presence around the world 11 countries 35 sites 12
More informationMMOG/LE OVERVIEW STREAMLINE AND OPTIMIZE SUPPLY CHAIN MANAGEMENT WITH QAD MMOG/LE SOLUTIONS IMPROVE PERFORMANCE IN THE AUTOMOTIVE SUPPLY CHAIN
MMOG/LE OVERVIEW STREAMLINE AND OPTIMIZE SUPPLY CHAIN MANAGEMENT WITH QAD MMOG/LE SOLUTIONS IMPROVE PERFORMANCE IN THE AUTOMOTIVE SUPPLY CHAIN The growing global automotive industry depends on a standard
More informationI-Track Software. A state of the art production and warehouse management system designed for Food and Beverage Manufacturers. Overview 2.
Overview 2 Features 3 Benefits 4 I-Track Software A state of the art production and warehouse management system designed for Food and Beverage Manufacturers Site Assessment 5 Integrated Plant Floor Execution
More informationSage X3 for Food & Beverage
Sage X3 for Food & Beverage for Food & Beverage Adopt a faster, simpler, more flexible solution with full business and HRM capabilities. Sage X3 provides the next generation of business solutions for your
More informationKOLLMORGEN. Title: Standard Operating Procedure Counterfeit Parts
Approved By: Elliott Major Date: 11-19-09 Page 1 of 9 Rev ECO Date Approve Rev ECO Date Approve A R01_13541 07-23-10 DWL B R01_14787 12-15-11 DWL C R01_14910 03-07-12 DWL D R01_14964 04-16-12 DWL 1.0 Purpose
More informationImproving Uptime in Aseptic Processing of Pharmaceutical Liquids with Blow-Fill-Seal
Improving Uptime in Aseptic Processing of Pharmaceutical Liquids with Blow-Fill-Seal Maximized uptime, minimized changeover time and efficient OEE are key factors that have influenced the acceptance of
More informationMedical Device Packaging and Sterilization: What you need to know to protect your product
Medical Device Packaging and Sterilization: What you need to know to protect your product By Wanda I. Colón-Rivera, PE ASQ-CQA, CMQ/OE, CSSBB When a medical device manufacturer designs and develops an
More informationOMCL Network of the Council of Europe QUALITY MANAGEMENT DOCUMENT
OMCL Network of the Council of Europe QUALITY MANAGEMENT DOCUMENT PA/PH/OMCL (11) 204 3R HANDLING AND USE OF REFERENCE STANDARDS IN THE OMCL NETWORK Full document title and reference Document type Legislative
More informationA Simple Guide to Material Master Data Governance. By Keith Boardman, Strategy Principal
A Simple Guide to Material Master Data Governance By Keith Boardman, Strategy Principal DATUM is an Information Management solutions company focused on driving greater business value through data. We provide
More informationBUSINESS TO MANUFACTURING (B2M) COLLABORATION BETWEEN BUSINESS AND MANUFACTURING USING ISA-95 ABSTRACT
BUSINESS TO MANUFACTURING (B2M) COLLABORATION BETWEEN BUSINESS AND MANUFACTURING USING ISA-95 Dennis Brandl dennis.brandl@sequencia.com Sequencia Corporation ABSTRACT Integrating business and manufacturing
More informationWhat makes Process Process?
What makes Process Process? #1 First Prize Award Winner Best Presentation South African Production & Inventory Control Society Process ERP Partners, LLC Suite 334 11 So. Angel Street Providence, RI 02906
More informationMarken For more information visit: www.marken.com
ceocfointerviews.com All rights reserved! Issue: January 18, 2016 The Most Powerful Name in Corporate News Global Supply Chain Service Provider to the Pharmaceutical and Healthcare Industry We are tracking
More informationLogistics Solutions. Intimate Involvement for Personalized Solutions
Logistics Solutions Intimate Involvement for Personalized Solutions Close Collaboration for Total Understanding When you have a committed logistics partner planning and implementing a supply chain solution
More informationEden Biodesign ebook Monoclonal Antibody Production: Building the Platform
Eden Biodesign ebook Monoclonal Antibody Production: Building the Platform CHAPTER 1: Overview CHAPTER 2: Challenges CHAPTER 3: Purification Methodology CHAPTER 4: Results CHAPTER 5: About Eden Biodesign
More informationINTRODUCTION TO MACHINE-VISION INSPECTION
INTRODUCTION TO MACHINE-VISION INSPECTION Machine vision is used in virtually all manufacturing industries to boost quality, productivity, efficiency, and regulatory compliance. Simply put, machine-vision
More informationLiquid II Cell Culture Media Manufacturing Plant. Overview Facilities Water for Injection Sterile Environment Media Handling Cleanroom Interior
Liquid II Cell Culture Media Manufacturing Plant Overview Facilities Water for Injection Sterile Environment Media Handling Cleanroom Interior Overview History of BioConcept and Amimed BioConcept has close
More informationLABELMANAGEMENT WITH SAP - INTEGRATION
LABELMANAGEMENT WITH SAP - INTEGRATION Vetter Pharma-Fertigung GmbH & Co. KG LABELING SOLUTIONS FOR PROFESSIONALS SAP Labelmanagement from OPAL and BarTender label software from Seagull Scientific ensure
More informationELA Standards of Competence on the Supervisory/Operational Management Level
ELA Standards of Competence on the Supervisory/Operational Management Level 2.0 Basic Supply Chain Concepts 2.0.01 Explain the scope and role of component activities within the supply chain 2.0.02 Map
More informationSUPPLIER QUALITY MANAGEMENT SYSTEM QUESTIONNAIRE
Company Name Street Address City, State, Zip code Phone Number Fax Company Website Email Address ORGANIZATION NAME PHONE NUMBER EMAIL ADDRESS President/CEO General Manager Engineering Manager Production
More informationDemand Forecast. Actual Orders. Order Forecast Collaboration: Benefits for the Entire Demand Chain. Integrating people, process and IT.
Forecast Collaboration: Benefits for the Entire Demand Chain In the recent past, suppliers and retailers often viewed themselves as adversaries. Retailers would order what they wanted a lead time prior
More informationPolyolefin Heat Shrink Tubing for Tight-Tolerance Medical Applications
Polyolefin Heat Shrink Tubing for Tight-Tolerance Medical Applications Understanding the Advantages and Development Process By Apur Lathiya Vice President and General Manager, Vesta Thermoplastics Division
More informationORACLE INVENTORY MANAGEMENT CLOUD
ORACLE INVENTORY MANAGEMENT CLOUD Inventory is a major asset for many organizations, and effectively managing inventory, including the related inventory movement transactions, can impact your bottom line.
More informationDepartment of Food Science Food Processing FSE98(10-99)
Department of Food Science Food Processing FSE98(10-99) Choosing and Using a Copacker John E. Rushing, Ph.D. What is a copacker? Copackers manufacture and package foods for other companies to sell. These
More informationThe purpose of this Supplier Quality Standard is to communicate the expectations and requirements of Baxter Healthcare Corporation to its suppliers.
Supplier Quality Standard 1.0 Purpose The purpose of this Supplier Quality Standard is to communicate the expectations and requirements of Baxter Healthcare Corporation to its suppliers. These expectations
More informationUNICEF s Quality Assurance System for Procurement of Micronutrient Powders (MNP)
UNICEF s Quality Assurance System for Procurement of Micronutrient Powders (MNP) Nutrition Supplier Meeting, June 30, 2015 Dimitris Catsoulacos Quality Assurance Specialist PRESENTATION OVERVIEW Quality
More informationEUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERAL. EudraLex. The Rules Governing Medicinal Products in the European Union
EUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERAL Health systems and products Medicinal products- authorisations, European Medicines Agency Brussels, EudraLex The Rules Governing Medicinal
More informationPharmaceutical Quality Systems: US Perspective
Pharmaceutical Quality Systems: US Perspective Rick Friedman Associate Director, Office of Manufacturing and Product Quality Center for Drug Evaluation and Research Topics Background: The ICH Q10 Pharmaceutical
More informationProcedure for Procurement and Receipt
Procedure for Procurement and Receipt 1.0 Purpose - To ensure that all supplies, equipment and services purchased by the State Crime Laboratory (Laboratory) are properly procured and received. 2.0 Scope
More informationQUALITY MANUAL REVISION RECORD
Page 2 of 31 REVISION RECORD Date Rev Description Jun 18, 2007 N/C Original Issue Sep 16, 2009 A Update to ISO 9001:2008 Standard. Feb 04, 2010 B Revised exclusions, removed (Except 7.3.7 from the exclusion
More informationGRADUATE CERTIFICATE IN GOOD MANUFACTURING PRACTICE (GMP) Plan your career for tomorrow and you will be ahead of your competitors
GRADUATE CERTIFICATE IN GOOD MANUFACTURING PRACTICE (GMP) Plan your career for tomorrow and you will be ahead of your competitors This course is a distance-learning program that will culminate in a Graduate
More informationProviding Trusted and Innovative Solutions t o the Life Science Communities
Providing Trusted and Innovative Solutions t o the Life Science Communities Eurogentec Eurogentec is a leading supplier of trusted and innovative reagents, kits, specialty products and custom research/development
More informationQuality Agreement. by and between. Supplier Name. Address: and. Client Name: Address:
NOTE TO USERS This Quality Agreement template was developed by the Bulk Pharmaceutical Task Force (BPTF), an affiliate organization of the Society of Chemical Manufacturers and Affiliates (SOCMA), as a
More informationCatalent Biologics & Clinical Supplies The SMART Solution
Catalent Biologics & Clinical Supplies The SMART Solution Advanced Technology and Integrated Solutions From DNA to Clinical Supply & Cold Chain Distribution Dr. Florian Schwaak Account Manager Germany
More informationOVERVIEW OF STANDARD 7E & STANDARD 20
Standard for Thermal Transport Packaging Used in Parcel Delivery System Shipment 7E 2 010 ISTA 7E Usage Modes VERSION DATE OCTOBER 2010 Initial Release ISTA, Distributing Confidence, Worldwide ISTA 7-Series
More information12 Tips for Successful Medical Equipment Outsourcing
REPRINTED FROM MD&DI APRIL 2009 12 Tips for Successful Medical Equipment Outsourcing Successful outsourcing is contingent upon knowing your company s needs and carefully selecting a supplier. Milton Frank
More informationSupplier Quality Assurance Requirements Manual
12716 EAST PINE STREET TULSA, OK 74116 Supplier Quality Assurance Requirements Manual Approved: Mike Collins Quality Assurance Manager Precise Machining & Manufacturing 1 Record of Revisions Revision D
More informationSubject: Lot, Batch & Serial # System - 1 - Created QC/ Edited by Paul DiMarco Approval/Effective Date: 01/01/2002
- 1-1.) Scope: This procedure covers the issuance and use of Lot, batch and serial numbers for Certificate of Analysis, Batch Records and Product Labels. 2.) Normative References: SOP 4-2-2 Quality Manual
More informationDISCUSSION TOOL PRESENTED TO THE AABB CT REGULATORY AFFAIRS SUBSECTION
1 US FDA Form 483: A Case Study DISCUSSION TOOL PRESENTED TO THE AABB CT REGULATORY AFFAIRS SUBSECTION DEVELOPED BY FRAN RABE 2 Introduction This case study is intended to extract portions of information
More informationWorking Party on Control of Medicines and Inspections. Final Version of Annex 16 to the EU Guide to Good Manufacturing Practice
Version 8 (final) EUROPEAN COMMISSION ENTERPRISE DIRECTORATE-GENERAL Single market, regulatory environment, industries under vertical legislation Pharmaceuticals and cosmetics Brussels, July 2001 S\common\legal-legislation\75-319nd81-851\91-356\eudralexvol4\Annex
More informationFirst Strand cdna Synthesis
380PR 01 G-Biosciences 1-800-628-7730 1-314-991-6034 technical@gbiosciences.com A Geno Technology, Inc. (USA) brand name First Strand cdna Synthesis (Cat. # 786 812) think proteins! think G-Biosciences
More informationPresentation from: The Cyclops Group. Everything you expect from a class leading independent stocking distributor... and more.
Presentation from: The Cyclops Group Everything you expect from a class leading independent stocking distributor... and more. Cyclops Group, Link Business Park, Osbaldwick, York, YO10 3JB Tel: +44 (0)1904
More informationThe fact is that 90% of business strategies are not implemented through operations as intended. Overview
Overview It is important to recognize that a company s network determines its supply chain efficiency and customer satisfaction. Designing an optimal supply chain network means the network must be able
More informationMicrobiology and Auditing. Don Singer
Microbiology and Auditing Don Singer ASQ Northeast Pharmaceutical GMP/Quality Conference 2011 Through the eyes of a Microbiologist Microbiology Audit = Inspection / Investigation Systematic Auditing Planning
More informationImpact of Formula-Based ERP Applications on Pharmaceutical Manufacturers
Impact of Formula-Based ERP Applications on Pharmaceutical Manufacturers Executive Summary Whether you re in the process of re-evaluating your existing ERP application or looking to replace your spreadsheets,
More informationCHAPTER 6 PROCUREMENT AND SUPPLY OF PHARMACEUTICAL PRODUCTS IN THE PUBLIC AND PRIVATE MEDICAL SECTORS
CHAPTER 6 PROCUREMENT AND SUPPLY OF PHARMACEUTICAL PRODUCTS IN THE PUBLIC AND PRIVATE MEDICAL SECTORS Overview 6.1 This chapter sets out the Review Committee s findings and recommendations on procurement
More informationSafe%Feed/Safe%Food% Overview of Certification Programs: Why Should a Feed Mill Get Certified?
Safe%Feed/Safe%Food% Overview of Certification Programs: Why Should a Feed Mill Get Certified? Henry Turlington, Ph.D. Director, Quality & Manufacturing Regulatory Affairs American Feed Industry Association
More informationPPG SUPPLIER DEVELOPMENT ASSESSMENT
Supplier: Address: Products: Assessment Date: Assessment Team: Certification: Supplier Contacts Position E-mail Phone General Comments: Assessment Results Summary Sections Non-conformity Action Point Quality
More informationCOMMODITY MANAGEMENT AND ERP
WHITE PAPER COMMODITY MANAGEMENT AND ERP Introduction Over the last several years, the phenomenal growth and expansion of wholesale commodity trading has begun to have a significant impact on both business
More informationWarehouse Management MICROSOFT BUSINESS SOLUTIONS AXAPTA
Warehouse Management MICROSOFT BUSINESS SOLUTIONS AXAPTA Microsoft Business Solutions Axapta Warehouse gives you the flexibility and control you need to optimise your entire warehouse management cycle
More informationCareer Bands, Career Levels, Functions and Disciplines
Career Bands, Career Levels, Functions and Disciplines General Overview This section provides job matching documentation used for this survey report. Career Band Summary Description for the Supervisory/Management
More informationEXPANDING OPPORTUNITIES WITH
EXPANDING OPPORTUNITIES WITH A SIMPLIFIED SUPPLY CHAIN: Transformational strategies for improving outcomes and cost along the medical device value chain In the era of cost-conscious, value-based healthcare,
More informationPRECISION METAL STAMPINGS & ASSEMBLIES FOR THE MEDICAL DEVICE INDUSTRY
PRECISION METAL STAMPINGS & ASSEMBLIES FOR THE MEDICAL DEVICE INDUSTRY COMPONENTS & ASSEMBLIES FOR SURGICAL INSTRUMENTS & CLASS-CRITICAL IMPLANTABLE DEVICES COMPONENTS AND ASSEMBLIES FOR INDUSTRIES, INC.
More information1. Scope This SOP covers requirements for PHARMCO-AAPER s Quality Management System
Page 1 of 8 1. Scope This SOP covers requirements for PHARMCO-AAPER s Quality Management System 2. Application This Standard Operating Procedure applied to the entire Quality Management System as it relevant
More informationDurapore. High Throughput Flow Rates. Durapore 0.2 µm hydrophilic
 Durapore CBR 0.2 µm Bioburden Reduction Filters Lenntech Tel. +31-15-261.09.00 Fax. +31-15-261.62.89 DAT A SHEET For fine filtration of deionized water, in vitro diagnostics, oral suspensions, bulk pharmaceutical
More informationIn a Global Economy: Staying Competitive in the Multi-Channel Distribution Industry Through Effective Use of Best Practices
In a Global Economy: Staying Competitive in the Multi-Channel Distribution Industry Through Effective Use of Best Practices OVERVIEW In the current global economic environment, multi-channel distribution
More informationIntegrated Supply Chain Solutions for. Life Science Industry. Consider It Delivered
Integrated Supply Chain Solutions for Life Science Industry Consider It Delivered Business Profile With an Irish Medicines Board (IMB) approved Wholesalers Authorisation for its warehousing operation,
More informationAPTEAN PROCESS MANUFACTURING
APTEAN PROCESS MANUFACTURING Everything Process Manufacturers Need Is Baked Into Aptean s Process Manufacturing Suite BROCHURE Are we going to ship on time? What if we were audited today? Where are our
More informationQAD SOLUTIONS ARE BUILT FOR FOOD AND BEVERAGE MANUFACTURERS, BUILT FOR YOU
QAD SOLUTIONS ARE BUILT FOR FOOD AND BEVERAGE MANUFACTURERS, BUILT FOR YOU Food and beverage manufacturers produce a wide array of products from soda, wine, dairy, and fruits and vegetables to oils, spices
More informationQAD ENTERPRISE APPLICATIONS
IS BUILT FOR MANUFACTURERS, BUILT FOR YOU Effective manufacturers depend on their enterprise resource planning (ERP) solution to streamline business operations and to scale and adapt as their business
More informationORACLE PROCESS MANUFACTURING QUALITY MANAGEMENT
ORACLE PROCESS MANUFACTURING QUALITY MANAGEMENT KEY FEATURES Automated stability study management Lot expiration handling and retesting Potency or variability management Quality holds during receiving
More informationOutsourcing Manufacturing: A 20/20 view
Outsourcing Manufacturing: A 20/20 view OUTSOURCING MANUFACTURING is becoming a well-established approach for companies that want to strategically manage materials in today s fast-paced business environment.
More informationStrategic Planning Presentation Enterprise Ireland Finance 4 Growth seminar, Cork, 10 th March 2015
Strategic Planning Presentation Enterprise Ireland Finance 4 Growth seminar, Cork, 10 th March 2015 Company Overview HQ in Cork with distribution hubs in Dublin & UK. 3 Divisions Chemicals, Paint and Food
More informationPOWER. Your Partners in Availability POWER
Your Partners in Availability The Service Arm for All Liebert Products We have the industry-leading technical expertise, top onsite response times and the most sophisticated parts logistics in the industry.
More informationMicrosoft Dynamics AX can help streamline processes and minimize the costs of carrying inventory for firms that produce goods from raw materials.
Microsoft Dynamics AX for discrete manufacturing Success in the manufacturing industry requires that you produce the right products, in the right quantities, at the right time, with good quality, and at
More informationKaras Engineering AS9100 QUALITY MANAGEMENT SYSTEM MANUAL
Karas Engineering AS9100 QUALITY MANAGEMENT SYSTEM MANUAL Revision D October 27, 2015 Statement of Commitment and Authority Commitment This Quality Management System Manual (QMSM) delineates the processes,
More informationDHL AIR FORWARD DELIVERING RELIABILITY AT THE SPEED YOU NEED
DHL AIR FORWARD DELIVERING RELIABILITY AT THE SPEED YOU NEED Expect more from your Air Freight partner Today s dynamic global markets demand an Air Freight partner who is able to take on more of your logistics
More informationMaximize Your Up Time With A Preventative Maintenance Plan Designed For The Way you Work. 1970 s. 1980 s. 1990 s. 2000 s.
TECHNICAL BULLETIN 921 1970 s 1980 s 1990 s 2000 s Maximize Your Up Time With A Preventative Maintenance Plan Designed For The Way you Work. Rudolph today A Service Or PM Plan Designed For Your Lab cost
More informationMaking SOP Training More Effective
By David Peterson, Director, GMP and Quality Systems, UL EduNeering SOPs are critical to efficient operations, quality control and regulatory compliance. This paper reviews best practices for the Life
More information