Technically Unavoidable Particles Profile (TUPPs) Guide
|
|
- Kory Sims
- 6 years ago
- Views:
Transcription
1 Technically Unavoidable Particles Profile (TUPPs) Guide Priscilla Zawislak Global Regulatory Affairs Manager Ashland Inc. Chair Elect, IPEC-Americas 1
2 Agenda Introduction and Background Key Concepts and Definitions TUPPs Guide Overview 2
3 Introduction Technically unavoidable particles are present in excipients A level of ZERO is not achievable The number of process inherent, technically unavoidable particles is very small compared to the batch size for most excipients Six sigma or higher performance level is the norm Incremental improvements yield relatively minor results Step change improvements in performance may not be possible and would generally be quite expensive Basis documents: IPEC PQG GMP Guide ICH Q9 Quality Risk Management
4 Background Previous guidance from IPEC, compendia or regulators has not dealt with this issue effectively Materials, and in some cases entire excipient lots, are rejected unnecessarily Users and makers spend time, money and resources investigating particles that are technically unavoidable and do not pose a risk to patient safety In many instances, the identity and origin of these particles are known and have been extensively investigated by the excipient manufacturer. The particles are inherent to the manufacturing process or excipient The Technically Unavoidable Particle Profile Guide provides a pathway to share identity and origin data for particles typically found in excipients.
5 IMPORTANT DEFINITIONS AND CONCEPTS
6 Technically Unavoidable Particles Particles that are visibly different from the bulk of the material when viewed with the naked eye within the container or against a suitable background (examples are size, shape, color, number, texture ), AND: Are inherent to the excipient manufacturer s process, product or raw materials Are technically unavoidable
7 Technically Unavoidable The non-intended presence of a small quantity of particles, stemming from impurities of natural or synthetic ingredients, the manufacturing process, storage, migration from packaging, which is technically unavoidable in good manufacturing practice* AND do not pose risk to patient safety * Definition contained in Article 17 of the Regulation (EC) No. 1223/2009 for the European Parliament and of the Council of 30 November 2009 on cosmetic products
8 Technically Unavoidable Particle Profile The Technically Unavoidable Particle Profile (TUPP) documents the excipient maker s knowledge of: the types of technically unavoidable particles (TUPS) their origin for a particular manufacturing process or product The TUPP includes results of prior investigations of various particles, results of risk assessments, raw material characterization, unavoidable particles from product packaging, etc. The TUPP should exist in a form that can be shared The discussion of the TUPP best occurs during excipient qualification to avoid future complications
9 Technically Unavoidable Particle Profile, continued Although significant information may exist for TUPs and their origin; specifications or limits cannot and/or should not be expected on Certificates of Analysis. The insignificant number of particles relative to batch size and the intermittent nature of their observance make a specification unrealistic and unreliable Where aesthetically unacceptable, limits on TUPs (and methods) may be an item for agreement between the user and excipient maker Excursions above agreed TUP limits cannot always be prevented as the low levels and low detectability may be beyond the capability of the process
10 Foreign/Atypical particles These particles are not consistent with the technically unavoidable particle profile Atypical particles may not have been previously encountered or identified; therefore, require further investigation to determine whether they are foreign or inherent to the process or product. Must be investigated on a case by case basis Investigation results should be shared with the user Depending on the results of the investigation and the user s risk assessment, an acceptance decision must be made by the user (In accordance with the principles of ICH Q9 Quality Risk Assessment) If the investigation indicates the presence of foreign contamination, the material should be rejected and returned to the excipient supplier The final disposition would be the excipient supplier s responsibility
11 OVERVIEW
12 Scope and Basis The IPEC-Americas Technically Unavoidable Particle Guide is applicable to excipients intended for use in drugs Patient safety is paramount Science and risk-based approaches Out of scope of the guide are excipients intended for: Parenteral or ocular use Sterile and/or pyrogen free The guide is not meant to deal with foreign contamination/adulteration which can be a failure of Good Manufacturing Practices (GMPs), and is unacceptable This guide is not a stand alone document A predicate requirement is compliance with the IPEC PQG GMP Guide The principles of risk assessment established in ICH Q9 Quality Risk Management should be considered in decision making
13 General Principles The guide Is not intended to condone poor GMPs Assumes full compliance with appropriate GMPs and is not applicable to objectionable particles resulting from contamination or adulteration Encourages a risk-based approach for evaluating visible particles in excipients Provides for the sharing of information by excipient manufacturers with their pharmaceutical customers, for the purpose of understanding the technically unavoidable particles Provides an approach for investigation of rare occurrences when a previously unobserved particle is found by the end user
14 General Considerations The guide is not about avoiding responsibility of GMPs quite the contrary Acknowledgement of the concept of technically unavoidable particles (TUPs) assumes implementation of available technologies to mitigate particle formation and inclusion in excipients When building in mitigation strategies for new plants or retrofitting existing plants Do what is possible and economically viable When employing appropriate mitigations, the guide will aid both users and makers in determining path forward regarding those particles that will always be present Reality is that this phenomenon is not new TUPs HAVE always been in excipients and to some extent WILL ALWAYS be in excipients
15 Risk assessment When aware that a product / process could result in TUPs, an excipient manufacturer should perform/document a risk assessment to identify and assess the types of particles that may be present Common risk assessment models are available for this purpose Some examples of risk assessment models are characterized in ICH Q9 Quality Risk Management Makers should be willing to share the results of risk assessment The method for sharing this information should be determined between the maker and the user, since some of this information may be considered confidential Excipient users should evaluate the information provided using the concepts of the guide and then evaluate the risk to patient safety as it relates to their application
16 Types of TUPs Charred particles - discolored due to exposure to heat Particles representing process materials of construction due to normal and reasonably expected wear Particles consistent with routinely used gaskets, seals, filters, etc. Equipment components are known to wear and are therefore routinely replaced on a preventive maintenance schedule. Thus, particle shedding should be considered a normal part of the process Materials of construction for these items should be food grade or food contact approved or otherwise justified and of appropriate construction Particles containing traces of lubricants, greases and oils or like materials may be discolored these too should be food grade or food contact approved where possible
17 Types of TUPs, continued Packaging component particles These particles are small, unavoidable, materials of construction of the packaging, e.g. cardboard or paper shedding. Misshapen or morphologically distinct particles, including but not limited to: Compressions or agglomerations of particles Elongated and/or tangled particles Flakes Color variation inherent to the product Intrinsic components carried through from raw materials (mined materials or those sourced from natural products)
18 Technically Unavoidable Particle Profile The excipient manufacturer has an obligation to help users understand the nature of particles observed in the excipient, and to ensure that these particles are not foreign contamination Assistance could be as simple as exchanging information indicating that the particle is consistent with the manufacturing process and would therefore considered technically unavoidable
19 Technically Unavoidable Particle Profile Examples of some of the types of information or data that may be considered as inputs for the development of the TUPP Photographs, chemical analysis, physical characterization, and other forms of characterization as applicable Discussion of the investigation process for unusual findings Heat sources frictional and added heat sources (drying, distillation, etc.) Discussion and trending of periodic particle types (risk assessment and decisions based on the observed trends) Discussion of the continuous improvement strategy/processes relative to visible particles and their formation List of lubricants, gasket materials, sealants, etc Discussion of how typical visible particles are minimized and controlled Discussion of the preventive maintenance (of process equipment AND visible particle control equipment) List of materials of construction
20 Manufacturer s Expectations An excipient manufacturer should understand and have available a Technically Unavoidable Particle Profile of the known technically unavoidable or inherent particles for a particular excipient The scope and complexity of the profile depends on the excipient For those excipients that rarely exhibit these types of particles, the TUPP could be as simple as a statement that they are not normally present For excipients that are likely to contain technically unavoidable particles, either through process related formation, raw material introduction or morphologically distinct particles of product, the TUPP will likely be more comprehensive
21 Manufacturer s Expectations Consistent with GMPs, in-process sources of particles should be identified and where possible mitigation strategies and technologies employed Once a mitigation technology is employed, it should be properly maintained to ensure continued effectiveness Any remaining particles would be characterized as technically unavoidable if the manufacturer has met the obligations of GMP Periodic evaluation of mitigation strategies and technologies and continuous improvement initiatives should be included as part of the GMP quality system related to typical visible particles
22 Atypical Particles Particles not part of a TUP profile are expected to undergo a full investigation Particles not part of a TUP profile(i.e. not previously observed) but known to be consistent with manufacturing equipment, facility, gaskets, lubricants materials of construction, should the acceptable based on a documented risk assessment When an investigation identifies a new type of technically unavoidable particle, the results should be included in TUPP When an investigation identifies something other than a technically unavoidable particle or particle inherent to process materials of construction: Return of the material would be expected The excipient manufacturer determines the appropriate disposition of the material
23 Investigation of Atypical Particles The more information provided by the user, the easier and faster an investigation can be completed on the maker side, and vice versa. It is the user s responsibility to provide as much information as possible about how the particle was found such as: Has the particle been analyzed or has the composition been determined? If found inside container, was/were the particle(s) found inside or outside the liner? Was/were the particle(s) found in the product or in a sample that was removed from the product? How is/are the container(s) opened, and is/are it/they cleaned prior to opening? Can a sample of the particle be provided to the manufacturer for evaluation? Was/were the particle(s) found inside the excipient container or during screening/use? Are multiple or only one suppliers asked to provide information? if only one, could they be suspected as the source? Can a digital photo be provided? Dimensions/color/texture, etc. of particle(s) Are particles from a single excipient or a mixture of components when the particle was found? How is/are the container(s) sampled?
24 User Evaluation Criteria The purpose of the guide is to provide understanding of the scope of normal, inherent and technically unavoidable particles between excipient manufacturers and users. When particles are observed by a user, the guide describes the expectations around the exchange of information that would constitute an investigation and lead to the proper disposition of affected product The disposition should not normally result in the rejection of material when the observed particles are within the range of normal or typical particles previously described as likely to be observed with the excipient
25 User Evaluation When a visible particle is observed by the user, the excipient manufacturer should be contacted to identify the particle as well as its source This exchange of information between user and maker may take the form of a TUPP or a report of the result of the maker s evaluation of the particle This should provide sufficient information to allow the user to make a risk assessment for their product or application If it is determined that the particle is typical and technically unavoidable, it is important for users to understand that these particles have historically been present in excipients, and generally pose no risk to patient safety
26 User Evaluation, continued Unique issues related to TUPs that may be involved with the application or dosage form should be discussed with the supplier Reduced levels of TUPs necessary to support the application or dosage form should also be discussed with the supplier When possible, potential reduction in TUPs may require additional manufacturing steps Additional manufacturing steps may change the performance characteristics of the excipient, introduce new or different technically unavoidable particles increase costs In many cases, reduced levels of TUPs will not be technically or economically achievable
27 Is There a Safety Concern? This is one of the most important questions to answer Usually TUPs inherent to the process are safe and there is no risk The inherent TUPs may be the same excipient possibly discolored It may be the starting raw material The TUPs may be part of the normal wear and tear of the equipment or packaging and can be safely removed REMEMBER: They have ALWAYS been present There may be instances when particles could pose a safety concern Usually this is not inherent to the excipient but is contamination This tends to be rare but possible This is a breach of GMP Ongoing communication between Maker and User is the key to quickly resolving questions around visible particles
28 Conclusions The IPEC-Americas Technically Unavoidable Particle Profile Guide provides a path for identification of particles and guidance for risk-based decision making IPEC recommends use by Makers & Users when they discuss TUPs Honest, transparent discussions at all phases of development must be the norm between maker and users Risk-based approaches to process inherent, technically unavoidable particles
29 Acknowledgements Ann Van Meter Dow Chemical & Chair of IPEC-Americas GMP Committee
30 Thank You!
Challenges of Implementation of ICH Q 8
Challenges of Implementation of ICH Q 8 A Regulatory Perspective Dr. Susanne Keitel BioKorea, Seoul, September 2007 Overview of the Presentation ICH Q 8: Background; EU Experience Design Space Associated
More informationImportance of ICH Guidance in Fulfilling Process Validation Requirements
Importance of ICH Guidance in Fulfilling Process Validation Requirements Presented by: Gamal Amer All rights reserved. Do not copy without permission. Principal 1 Premier Compliance Services, Inc. Process
More informationQ8 and Q8 annex An industry Perspective
Workshop on Implementation of ICH Q8/Q9/Q10 and Other Quality Guidelines Beijing December 2008 Q8 and Q8 annex An industry Perspective Brian Withers, Abbott Laboratories, United Kingdom I attend this conference
More informationPharmaceutical Manufacturing and Engineering Catalog Excerpt
Pharmaceutical Manufacturing and Engineering Catalog Excerpt PME 530 Introduction to Pharmaceutical Manufacturing Pharmaceutical manufacturing is vital to the success of the technical operations of a pharmaceutical
More informationRequirements in Other Countries PQRI+USP EI Workshop; Rockville, MD, Dr. Helmut Rockstroh
Requirements in Other Countries PQRI+USP EI Workshop; Rockville, MD, 2015 Dr. Helmut Rockstroh Overview Introduction - Scope Pharmacopoeial + HA Positions Examples / Case Studies Discussion 2 Introduction:
More informationTerrence Tougas. Dennis Sandell
Terrence Tougas Boehringer Ingeheim, Ridgefield, CT Dennis Sandell S5 Consulting, Lund, Sweden (c) 2011 Sandell & Tougas 1 Transforming the general concept of Quality into objective, well defined and actionable
More informationImplementing Quality Systems
Implementing Quality Systems CGMP By The Sea August 29, 2006 Chris Joneckis, Ph.D. Senior Advisor For CMC Issues Center For Biologics Evaluation And Research Add FDA Bar and Presentation Overview Driving
More informationApplication of Visible-Residue Limit for Cleaning Validation Richard J. Forsyth and Vincent Van Nostrand By Richard J. Forsyth,Vincent Van Nostrand
October 2, 2005 Application of Visible-Residue Limit for Cleaning Validation Richard J. Forsyth and Vincent Van Nostrand By Richard J. Forsyth,Vincent Van Nostrand Pharmaceutical plants must have visually
More informationEXPLORATION DEVELOPMENT OPERATION CLOSURE
i ABOUT THE INFOGRAPHIC THE MINERAL DEVELOPMENT CYCLE This is an interactive infographic that highlights key findings regarding risks and opportunities for building public confidence through the mineral
More informationPAPER No. 7: CRIMINALISTICS AND FORENSIC PHYSICS MODULE No. 11; TRACE EVIDENCE
SUBJECT FORENSIC SCIENCE Paper No and Title Module No. and Title Paper 7 : Criminalistics and Forensic Physics Module No. 11; Trace evidence Module Tag FSC_P7_M11 TABLE OF CONTENTS 1. Learning Outcomes
More informationTECHNICAL AND OPERATIONAL NOTE ON CHANGE MANAGEMENT OF GAMBLING TECHNICAL SYSTEMS AND APPROVAL OF THE SUBSTANTIAL CHANGES TO CRITICAL COMPONENTS.
TECHNICAL AND OPERATIONAL NOTE ON CHANGE MANAGEMENT OF GAMBLING TECHNICAL SYSTEMS AND APPROVAL OF THE SUBSTANTIAL CHANGES TO CRITICAL COMPONENTS. 1. Document objective This note presents a help guide for
More informationSHTG primary submission process
Meeting date: 24 April 2014 Agenda item: 8 Paper number: SHTG 14-16 Title: Purpose: SHTG primary submission process FOR INFORMATION Background The purpose of this paper is to update SHTG members on developments
More informationJune Phase 3 Executive Summary Pre-Project Design Review of Candu Energy Inc. Enhanced CANDU 6 Design
June 2013 Phase 3 Executive Summary Pre-Project Design Review of Candu Energy Inc. Enhanced CANDU 6 Design Executive Summary A vendor pre-project design review of a new nuclear power plant provides an
More informationValue Paper. Are you PAT and QbD Ready? Get up to speed
Value Paper Are you PAT and QbD Ready? Get up to speed PAT and Quality-by-Design As PAT and Quality -by-design (QbD) become an integral part of the regulatory framework, automation group ABB argues more
More informationCMC Topics and PMDA s activities Yoshihiro Matsuda, Ph.D.
CMC Topics and PMDA s activities Yoshihiro Matsuda, Ph.D. Senior Scientist (for Quality) Pharmaceuticals and Medical Devices Agency (PMDA) MFDS Nov 11, 2016 1 Agenda Introduction of PMDA ICH Q12 QbD assessment
More informationPreparing for the new Regulations for healthcare providers
Preparing for the new Regulations for healthcare providers Cathal Brennan, Medical Device Assessor HPRA Information Day on Medical Devices 23 rd October 2014 Brussels, 26.9.2012 COM(2012) 542 final 2012/0266
More informationJUST SCRATCHING THE SERVICE
CONTRACT MANUFACTURING, PACKAGING & NEW EQUIPMENT TECHNOLOGY FOR THE BIOPHARM/PHARMACEUTICAL INDUSTRY OFFICIAL MEDIA SPONSOR OF W W W. P H A R M P R O. C O M V O L U M E 3 0, N U M B E R 4 M AY 2 0 1 5
More informationWHITE PAPER FACILITY FOCUS: Next Generation Aseptic Manufacturing: An Eye-Opening Peek into the Future. By: Hite Baker
WHITE PAPER FACILITY FOCUS: Next Generation Aseptic Manufacturing: An Eye-Opening Peek into the Future By: Hite Baker August 2017 Introduction This Facility Focus Survey Report explores how to design sterile
More informationMA/INS/GMP/735037/2014 Annex 1 of the GMP Guidelines on Good Manufacturing Practice - Manufacture of Sterile Medicinal Products
31 March, 2015 European Medicines Agency GMP/GDP Inspectors Working Group (GMP/GDP IWG) 30 Churchill Place Canary Wharf London E14 5EU United Kingdom Subject: MA/INS/GMP/735037/2014 Annex 1 of the GMP
More informationASI 691 Prinicples of HACCP 1
Prerequisite Programs: GMP s, SOP s, SSOP s HACCP Does Not Stand Alone Must be built on existing food safety programs Prerequisite Programs Definition of Prerequisite Programs- Procedures, including Good
More informationGuidance for Industry
Guidance for Industry Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical CGMP U.S. Department of Health and Human Services Food and Drug Administration Center for Drug
More informationSTRATEGIES FOR SUCCESSFUL SCALE-UP USING QUALITY BY DESIGN
STRATEGIES FOR SUCCESSFUL SCALE-UP USING QUALITY BY DESIGN CHRISTOPHER J POTTER ISPE ADVISOR AND CMC CONSULTANT 1 AGENDA Background ICH Guidelines Terms and Definitions Supporting Information ISPE publications
More informationQuality assurance in the supply chain for pharmaceuticals from the WHO perspective
1 Quality assurance in the supply chain for pharmaceuticals from the WHO perspective Dr Sabine Kopp Quality Assurance and Safety: Medicines Medicines Policy and Standards World Health Organization Presentation
More informationUse of PFOA in critical photographic applications
Ref. Ares(2014)4210533-15/12/2014 Use of PFOA in critical photographic applications Eddy Michiels Agfa-Gevaert NV Chairman Chemical Compliance WG I&P Europe Imaging and Printing Association State of the
More informationQUALITY: BRACKETING AND MATRIXING DESIGNS FOR STABILITY TESTING OF NEW VETERINARY DRUG SUBSTANCES AND MEDICINAL PRODUCTS
VICH GL 45 (QUALITY) BRACKETING AND MATRIXING April 2010 For Implementation at Step 7 QUALITY: BRACKETING AND MATRIXING DESIGNS FOR STABILITY TESTING OF NEW VETERINARY DRUG SUBSTANCES AND MEDICINAL PRODUCTS
More informationWHITE PAPER FACILITY FOCUS: GMP Facility Modernization. By: David M. Marks, P.E.
WHITE PAPER FACILITY FOCUS: GMP Facility Modernization By: David M. Marks, P.E. July 2017 Introduction In recent years, intensified industry competition and cost pressures have renewed interest in modernizing
More informationUNIVERSITI TEKNOLOGI MARA WEAR CHARACTERIZATION BY OIL ANALYSIS IN AUTOMATIC AND MANUAL BUS ENGINE GEARBOX
UNIVERSITI TEKNOLOGI MARA WEAR CHARACTERIZATION BY OIL ANALYSIS IN AUTOMATIC AND MANUAL BUS ENGINE GEARBOX NORHANIFAH BINTI ABDUL RAHMAN Thesis submitted in fulfillment of the requirements for the degree
More information2008 Course Programs Schedule
2008 Course Programs Schedule Basic Laboratory Safety Laboratory Safety Biostatistics for the Non-Statistician - Basic Applied cgmps for Pharmaceutical and Allied Industries Good Clinical Practices (GCP)
More informationDepartment of Energy s Legacy Management Program Development
Department of Energy s Legacy Management Program Development Jeffrey J. Short, Office of Policy and Site Transition The U.S. Department of Energy (DOE) will conduct LTS&M (LTS&M) responsibilities at over
More informationPrivacy Policy SOP-031
SOP-031 Version: 2.0 Effective Date: 18-Nov-2013 Table of Contents 1. DOCUMENT HISTORY...3 2. APPROVAL STATEMENT...3 3. PURPOSE...4 4. SCOPE...4 5. ABBREVIATIONS...5 6. PROCEDURES...5 6.1 COLLECTION OF
More informationImpact of ICH Q9 and the application of Risk Management
Safeguarding public health Impact of ICH Q9 and the application of Risk Management An inspector s perspective on the impact on inspectional approaches and expectations Ian Thrussell Strategy and Development
More informationSAUDI ARABIAN STANDARDS ORGANIZATION (SASO) TECHNICAL DIRECTIVE PART ONE: STANDARDIZATION AND RELATED ACTIVITIES GENERAL VOCABULARY
SAUDI ARABIAN STANDARDS ORGANIZATION (SASO) TECHNICAL DIRECTIVE PART ONE: STANDARDIZATION AND RELATED ACTIVITIES GENERAL VOCABULARY D8-19 7-2005 FOREWORD This Part of SASO s Technical Directives is Adopted
More informationLens Impact Resistance Testing Plan Revised,
Forward Lens Impact Resistance Testing Plan Revised, 2013-12 The Vision Council (TVC) has developed a plan for labs that need to impact test plastic lenses in accordance with FDA requirements. The step-by-step
More informationIn practice, the question is frequently raised of what legislation applies to clamping devices that are intended to be used on machines.
VDMA Position Paper (Version from 22 nd June, 2017) Machine tools and manufacturing systems Precision Tools Clamping devices for use on machines This position paper is intended as information on how clamping
More informationCOMMISSION STAFF WORKING DOCUMENT. Implementation Plan. Accompanying the document
EUROPEAN COMMISSION Brussels, 2.2.2016 SWD(2016) 18 final COMMISSION STAFF WORKING DOCUMENT Implementation Plan Accompanying the document Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE
More informationIntellectual Property, Vaccine Production and Technology Transfer
Intellectual Property, Vaccine Production and Technology Transfer Vaccine Industry Perspective P. Fournier, On behalf of IFPMA Bio Group 19-20 April 2004, WHO HQ, Geneva 1 OUTLINE General considerations
More informationSAFETY ASSESSMENT METHODOLOGIES AND THEIR APPLICATION IN DEVELOPMENT OF NEAR SURFACE WASTE DISPOSAL FACILITIES ASAM PROJECT
SAFETY ASSESSMENT METHODOLOGIES AND THEIR APPLICATION IN DEVELOPMENT OF NEAR SURFACE WASTE DISPOSAL FACILITIES ASAM PROJECT B. Batandjieva, P. Metcalf (a) International Atomic Energy Agency Wagrammer Strasse
More informationFORTIES ESP FAILURE ANALYSIS EXPERIENCE 2014 EUALF
FORTIES ESP FAILURE ANALYSIS EXPERIENCE 2014 EUALF INTRODUCTION Dismantle Inspection and Failure Analysis (DIFA) has driven a number of key ESP improvements for Apache by properly establishing failure
More informationALL RAW MATERIALS ARE NOT CREATED EQUAL.
ALL RAW MATERIALS ARE NOT CREATED EQUAL. Meet Diagnostics Elite DIAGNOSTIC SOLUTIONS Reimagine what s possible. REDUCE RISK. INCREASE CONSISTENCY. The Diagnostics Elite program is more than just a set
More informationSTATE OF OHIO DEPARTMENT OF TRANSPORTATION SUPPLEMENT 1073 PRECAST CONCRETE CERTIFICATION PROGRAM JULY 20, 2018
STATE OF OHIO DEPARTMENT OF TRANSPORTATION SUPPLEMENT 1073 PRECAST CONCRETE CERTIFICATION PROGRAM JULY 20, 2018 1073.01 Program Overview 1073.02 Qualification 1073.03 Documentation Phase 1073.04 Documentation
More informationASEPTIC PROCESSING, TODAY AND FUTURE
ASEPTIC PROCESSING, TODAY AND FUTURE Dublin, Ireland, 4 October 2018 Marco Delgado Rueda ALL RIGHTS RESERVED 2018 PAREXEL INTERNATIONAL CORP. AGENDA Today s Reality and Needs Issues and Probable Causes
More informationMelbourne IT Audit & Risk Management Committee Charter
Melbourne IT 1.) Introduction The Board of Directors of Melbourne IT Limited ( the Board ) has established an Audit & Risk Management Committee. The Audit & Risk Management Committee shall be guided by
More informationPublic Art Mural Packet
Public Art Mural Packet October 2016 Thank you for your interest in the process for executing exterior murals on public or private property in within the City of Ashland. The attached documents are intended
More informationWG food contact materials
WG food contact materials Monday 30 January European Commission DG SANTE, Unit E2 Food Processing Technologies and Novel Foods Food Contact Materials This presentation does not present any official views
More informationBest Products to Use in a Healthcare Facility Repaint Project
Best Products to Use in a Healthcare Facility Repaint Project Introduction 03 Types of Products to Consider in Healthcare Painting Projects 04 Paints, Oil-based Paints, Water-based Paints 05 Paint Finishes,
More informationEssay Questions. Please review the following list of questions that are categorized by your area of certification. The six areas of certification are:
Essay Questions Please review the following list of questions that are categorized by your area of certification. The six areas of certification are: Environmental Assessment Environmental Documentation
More informationFOR READY MIXED PAINT, ALUMINIUM, BRUSHING, PRIMING, WATER RESISTANT, FOR WOODWORK
FOR BIS USE ONLY DOC:CHD 20(1907)C August 2011 BUREAU OF INDIAN STANDARDS Draft Indian Standard SPECIFICATION FOR READY MIXED PAINT, ALUMINIUM, BRUSHING, PRIMING, WATER RESISTANT, FOR WOODWORK (First Revision
More informationATDESIGN. Working with an Assignment Photographer
Working with an Assignment Photographer Making sure your project is professionally photographed is an essential step in communicating your ideas. With the photographs being used to market your firm s expertise,
More informationManufacturing Readiness Assessment Overview
Manufacturing Readiness Assessment Overview Integrity Service Excellence Jim Morgan AFRL/RXMS Air Force Research Lab 1 Overview What is a Manufacturing Readiness Assessment (MRA)? Why Manufacturing Readiness?
More informationSECTION SUBMITTAL PROCEDURES PART 1 - GENERAL 1.1 RELATED DOCUMENTS
SECTION 01 33 00 - SUBMITTAL PROCEDURES PART 1 - GENERAL 1.1 RELATED DOCUMENTS A. Drawings and general provisions of the Contract, including General and Supplementary Conditions and other Division 01 Specification
More informationAnalytical Methods and Sampling in the New Manufacturing Paradigm a Regulatory Perspective
Analytical Methods and Sampling in the New Manufacturing Paradigm a Regulatory Perspective Dr. Øyvind Holte Norwegian Medicines Agency EMA PAT team/ EDQM PAT working party 15 October, 2014, Heidelberg
More informationPhase 2 Executive Summary: Pre-Project Review of AECL s Advanced CANDU Reactor ACR
August 31, 2009 Phase 2 Executive Summary: Pre-Project Review of AECL s Advanced CANDU Reactor ACR-1000-1 Executive Summary A vendor pre-project design review of a new nuclear power plant provides an opportunity
More informationMidwest Regional Forum. Work Smarter Not Harder Leveraging Prior Knowledge to Accelerate CMC Programs
Midwest Regional Forum Work Smarter Not Harder Leveraging Prior Knowledge to Accelerate CMC Programs Tuesday, October 23, 2018 Loews Chicago O Hare Hotel Rosemont, IL Meeting Co-chairs: Sarah Demmon, Eli
More informationLAW ON TECHNOLOGY TRANSFER 1998
LAW ON TECHNOLOGY TRANSFER 1998 LAW ON TECHNOLOGY TRANSFER May 7, 1998 Ulaanbaatar city CHAPTER ONE COMMON PROVISIONS Article 1. Purpose of the law The purpose of this law is to regulate relationships
More informationE5 Implementation Working Group Questions & Answers (R1) Current version dated June 2, 2006
INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE E5 Implementation Working Group & (R1) Current version dated June 2, 2006 ICH Secretariat,
More informationTHE EM LEAD LABORATORY: PROVIDING THE RESOURCES AND FRAMEWORK FOR COMPLEXWIDE ENVIRONMENTAL CLEANUP-STEWARDSHIP ACTIVITIES
ABSTRACT THE EM LEAD LABORATORY: PROVIDING THE RESOURCES AND FRAMEWORK FOR COMPLEXWIDE ENVIRONMENTAL CLEANUP-STEWARDSHIP ACTIVITIES Greg B. Frandsen, Paul K. Kearns, and Raymond L. McKenzie Environmental
More informationUCCS University Hall Fire Sprinkler System Upgrade March 1, 2011 RTA SECTION SUBMITTAL PROCEDURES PART 1 - GENERAL
SECTION 013300 - SUBMITTAL PROCEDURES PART 1 - GENERAL 1.1 RELATED DOCUMENTS A. Drawings and general provisions of the Contract, including General and Supplementary Conditions and other Division 01 Specification
More informationEuropean Commission Health and Consumers Directorate General, Brussels
PDA EUROPE Adalbertstr, 9 16548 Glienicke/Berlin Germany Tel: +49 33056 2377-0 or -10 Fax: +49 33056 2377-77 or -15 www.pda.org OFFICERS Chair Harold Baseman ValSource Chair-Elect Martin VanTrieste Amgen
More informationPDA 71 Years of Connecting People, Science and Regulation
PDA 71 Years of Connecting People, Science and Regulation 1 I m happy to be here. Bom Dia. Estou feliz por estar aqui. Richard M. Johnson PDA President & CEO since 2009 38 years experience in US and International
More informationNORTHWESTERN UNIVERSITY PROJECT NAME JOB # ISSUED: 03/29/2017
SECTION 01 3300 - SUBMITTAL PROCEDURES PART 1 - GENERAL 1.1 RELATED DOCUMENTS A. Drawings and general provisions of the Contract, including General and Supplementary Conditions and other Division 01 Specification
More informationWANT TO PARTICIPATE IN RESEARCH? THERE S AN APP FOR THAT!
WANT TO PARTICIPATE IN RESEARCH? THERE S AN APP FOR THAT! SECURITY AND PRIVACY ISSUES WITH THE INCREASED USE OF CONNECTED DEVICES, APPS, AND SOCIAL MEDIA IN RESEARCH. PRESENTED BY: DAVID MATA, SENIOR ASSOCIATE,
More informationClaudio Pincus, President, The Quantic Group R. Owen Richards, President, Quantic Regulatory Services Daniel Pincus, Consultant, The Quantic Group
FDA Compliance and Regulatory Symposium Understanding the FDA s Latest cgmp Guidances: Opportunities and Pitfalls Claudio Pincus, President, The Group R. Owen Richards, President, Regulatory Services Daniel
More informationJ O I N T I N D U S T R Y S T A N D A R D. Requirements for Soldering Pastes J Standard 005A. December 2011
J O I N T I N D U S T R Y S T A N D A R D Requirements for Soldering Pastes J Standard 005A December 2011 Requirements for Soldering Pastes 1.0 SCOPE 1.1 Scope This standard prescribes general requirements
More informationEast Central College
SECTION 013300 - SUBMITTAL PROCEDURES PART 1 - GENERAL 1.1 RELATED DOCUMENTS A. Drawings and general provisions of the Contract, including General and Supplementary Conditions and other Division 01 Specification
More informationWeldment Visual Inspection Requirements
Table of Contents 1.0 Purpose / Scope / Timing... 2 1.1 Purpose / Scope... 2 1.2 Compliance Date... 2 2.0 Procedure / Quality Recd Requirements... 2 2.1 General Requirements... 2 2.2 Acceptance Criteria...
More informationVisual Testing of Pipe Threads
From NDT Technician, Vol. 10, No. 1, pp: 1 5. Copyright 2011 The American Society for Nondestructive Testing, Inc. The American Society for Nondestructive Testing www.asnt.org FOCUS AAs an oil well is
More informationQuality by Design and OINDP. Today s Presentation
Quality by Design and OINDP Setting the Stage John C Berridge IPAC-RS September 2008 Today s Presentation QbD definition Setting the stage from an ICH perspective Future Opportunities 2 QbD Definition
More informationHARDY UK LIMITED MACHINE GRINDING AND GRINDING WHEELS TECHNICAL GUIDE
HARDY UK LIMITED MACHINE GRINDING AND GRINDING WHEELS TECHNICAL GUIDE HARDY UK LIMITED MACHINE GRINDING AND GRINDING WHEELS Selecting the correct grinding in-feed speed and carriage traverse speed are
More informationFSMA Update. Jennifer Thomas Interim Director for FSMA Operations Center for Food Safety and Applied Nutrition Food and Drug Administration May 2018
FSMA Update Jennifer Thomas Interim Director for FSMA Operations Center for Food Safety and Applied Nutrition Food and Drug Administration May 2018 Foundational Rules Regulation Final Rule Published Preventive
More informationMISSISSIPPI STATE UNIVERSITY Office of Planning Design and Construction Administration
SECTION 01 340 - SHOP DRAWINGS, PRODUCT DATA AND SAMPLES PART 1 - GENERAL 1.1 RELATED DOCUMENTS A. Drawings and general provisions of the Contract, including General and Supplementary Conditions and other
More informationBeware the non-critical excipient
Beware the non-critical excipient Dr Brian A Carlin Director Open Innovation, Chair IPEC QbD Committee brian.carlin@fmc.com ExcipientFest 2012 1 Understand your raw materials http://www.ich.org/uploads/media/q-iwg_web_basic_training.pdf
More informationSIMULATION IMPROVES OPERATOR TRAINING ARTICLE FOR SEP/OCT 2011 INTECH
SIMULATION IMPROVES OPERATOR TRAINING ARTICLE FOR SEP/OCT 2011 INTECH Table of Contents teaser: Although simulation is the best training method for preventing accidents and improving process control, until
More informationJEFFERSON LAB TECHNICAL ENGINEERING & DEVELOPMENT FACILITY (TEDF ONE) Newport News, Virginia
BULLETIN NO. 6 TO THE PLANS AND SPECIFICATIONS FOR JEFFERSON LAB TECHNICAL ENGINEERING & DEVELOPMENT FACILITY (TEDF ONE) Newport News, Virginia EwingCole Architects.Engineers.Interior Designers.Planners
More informationEU GMP Evolution or Revolution Scope and drivers for EU GMP changes. August Gordon Farquharson
EU GMP Evolution or Revolution Scope and drivers for EU GMP changes August 2015 Gordon Farquharson EU & PIC/S Harmonisation at IWG level now Slide 2 PharmOut 2015 EU & PIC/S Harmonisation (1) What does
More informationCDER s Office of Pharmaceutical Quality (OPQ): Delivering on the 21 st Century Quality Goals
CDER s Office of Pharmaceutical Quality (OPQ): Delivering on the 21 st Century Quality Goals Lawrence X. Yu, Ph.D. Director (acting) Office of Pharmaceutical Science Food and Drug Administration IFPAC
More informationSECTION SHOP DRAWINGS, PRODUCT DATA, AND SAMPLES
SECTION 01 33 23 - SHOP DRAWINGS, PRODUCT DATA, AND PART 1 - GENERAL 1.1 SUMMARY A. Products include, but are not limited to, the following construction submittals: 1. Shop Drawings. 2. Product Data. 3.
More informationKANSAS DEPARTMENT OF TRANSPORTATION SPECIAL PROVISION TO THE STANDARD SPECIFICATIONS, 1990 EDITION
Sheet 1 of 5 KANSAS DEPARTMENT OF TRANSPORTATION SPECIAL PROVISION TO THE STANDARD SPECIFICATIONS, 1990 EDITION NOTE: This special provision is generally written in the imperative mood. The subject, "the
More informationNewmont Mining Corporation (Exact name of registrant as specified in its charter)
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D. C. 20549 Form SD SPECIALIZED DISCLOSURE REPORT Newmont Mining Corporation (Exact name of registrant as specified in its charter) Delaware
More informationUpdate on Progress Implementing the LSIF Anti- Counterfeit Medicines Action Plan
2013/SOM1/LSIF/009 Agenda item: 17 Update on Progress Implementing the LSIF Anti- Counterfeit Medicines Action Plan Purpose: Information Submitted by: United States Life Sciences and Innovative Forum Planning
More informationSHPO Position on The Roles of Archaeological Testing
Matthew H. Bilsbarrow March 17, 2003 Many excavations begin with test pits, and in fact many end with test pits. Hole and Heizer (1969:146) In general, testing is the limited examination of an archaeological
More informationThe TRIPS Agreement and Patentability Criteria
WHO-WIPO-WTO Technical Workshop on Patentability Criteria Geneva, 27 October 2015 The TRIPS Agreement and Patentability Criteria Roger Kampf WTO Secretariat 1 Trilateral Cooperation: To Build Capacity,
More informationForeign Particulate Matter testing using the Morphologi G3
Foreign Particulate Matter testing using the Morphologi G3 Introduction The Morphologi G3 with its Foreign Particle Detection capabilities allows the detection, enumeration and size classification of foreign
More informationQuality by Design, Clinical Relevance & Lifecycle Considerations
Quality by Design, Clinical Relevance & Lifecycle Considerations Robert Iser Acting Director Office of Process & Facilities / OPQ / CDER IFPAC 2016 1 FDA Quality Related Guidance and Initiatives Initiatives
More informationPharma Clean Assurance Programme.
Pharma Clean Assurance Programme www.lcpackaging.com Cleaner, safer and sustainable 02 Innovative FIBC programme for premium pharma clean packaging The biggest challenge for the pharmaceutical industry
More informationSECTION SUBMITTAL PROCEDURES
SECTION 01330 SUBMITTAL PROCEDURES PART 1 - GENERAL 1.1 DESCRIPTION A. Scope: 1. CONTRACTOR shall provide submittals in accordance with the General Conditions as modified by the Supplementary Conditions,
More informationLL assigns tasks to stations and decides on the position of the stations and conveyors.
2 Design Approaches 2.1 Introduction Designing of manufacturing systems involves the design of products, processes and plant layout before physical construction [35]. CE, which is known as simultaneous
More informationMarket Access and Environmental Requirements
Market Access and Environmental Requirements THE EFFECT OF ENVIRONMENTAL MEASURES ON MARKET ACCESS Marrakesh Declaration - Item 6 - (First Part) 9 The effect of environmental measures on market access,
More informationAudit History A Glance
Audit History Folder @ A Glance Audit History provides the history of each prescription. Rx # - Displays the Rx number of the fill or refill Doctor Name- Name of the prescriber associated with this prescription
More informationMilestone Society - Policy Note 2 Appropriate levels of Conservation for Milestones
Milestone Society - Policy Note 2 Appropriate levels of Conservation for Milestones The full conservation of milestones is a major task and the re-instatement and painting of a milestone to the highest
More informationLife Extension of Subsea Umbilical Systems Assessment Process Marian Copilet Technical Solutions Manager - APAC November 2016
Life Extension of Subsea Umbilical Systems Assessment Process Marian Copilet Technical Solutions Manager - APAC November 2016 2016 Oceaneering International, Inc. All rights reserved. About Oceaneering
More informationMATERIAL SPECIFICATION FOR PACKAGED SILICA FUME DRY GROUT MIXTURE FOR POST TENSIONING
ONTARIO PROVINCIAL STANDARD SPECIFICATION METRIC OPSS 1304 NOVEMBER 2005 MATERIAL SPECIFICATION FOR PACKAGED SILICA FUME DRY GROUT MIXTURE FOR POST TENSIONING TABLE OF CONTENTS 1304.01 SCOPE 1304.02 REFERENCES
More informationFactors that should be considered when selecting and sizing a mixer are:
Mixer Performance Mixing Equipment Factors that should be considered when selecting and sizing a mixer are: Production capacity requirements The bulk density of the mixed feed The amount of liquids to
More informationWhat We Heard Report Inspection Modernization: The Case for Change Consultation from June 1 to July 31, 2012
What We Heard Report Inspection Modernization: The Case for Change Consultation from June 1 to July 31, 2012 What We Heard Report: The Case for Change 1 Report of What We Heard: The Case for Change Consultation
More informationGeoff Brown & Associates Ltd
Geoff Brown & Associates Ltd REVIEW OF WESTERN POWER S APPLICATION FOR A TECHNICAL RULES EXEMPTION FOR NEWMONT MINING SERVICES Prepared for ECONOMIC REGULATION AUTHORITY Final 20 August 2015 Report prepared
More informationSPECIFICATIONS FOR A QUALITY LABEL FOR DECORATION OF COATED ALUMINIUM USED IN ARCHITECTURAL APPLICATIONS Edition
SPECIFICATIONS FOR A QUALITY LABEL FOR DECORATION OF COATED ALUMINIUM USED IN ARCHITECTURAL APPLICATIONS Master version ratified by the QUALIDECO Committee on 27 April 2017 Effective from 1 July 2017 Published
More informationInnovative Approaches to Pharmaceutical Development and Manufacturing Seminar Series
CAMO European Pharmaceutical Seminars Jan/Feb 2009 Innovative Approaches to Pharmaceutical Development and Manufacturing Seminar Series The Increasing Need of Multivariate Analysis for Process Understanding
More informationNEWMONT MINING CORPORATION ENVIRONMENTAL DEPARTMENT
Page: 1 of 6 Version: 1.1 NEWMONT MINING CORPORATION ENVIRONMENTAL DEPARTMENT Subject: Environmental Policies for Contractors and Vendors Effective Date: May 2006 I. PURPOSE These guidelines establish
More informationINCIDENTS CLASSIFICATION SCALE METHODOLOGY
8 May 2014 WORKING GROUP INCIDENT CLASSIFICATION UNDER SYSTEM OPERATIONS COMMITTEE Contents Revisions... 5 References and Related documents... 5 Change request... 5 1. Overview... 6 1.1 Objectives and
More informationDesign and industrial application of a microsurfacing pavement based on non-venezuelan bitumen.
Design and industrial application of a microsurfacing pavement based on non-venezuelan bitumen. Claude Emmanuel Giorgi 1, a, Frédéric Loup 2, Delphine Simard 2, Jérémy Thomas 3 1 Technical Management,
More informationGIE response to public consultation Interoperability NC of ENTSOG
Ref 13GIE052 April 2013 GIE response to public consultation Interoperability NC of ENTSOG Who is GIE? Gas Infrastructure Europe (GIE) is an association representing the sole interest of the infrastructure
More information