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Comprehensive quality by design for pharmaceutical product development and manufacture / / edited by Gintaras V. Reklaitis, Salvador Garcia-Munoz, Christine Seymour
Comprehensive quality by design for pharmaceutical product development and manufacture / / edited by Gintaras V. Reklaitis, Salvador Garcia-Munoz, Christine Seymour
Pubbl/distr/stampa Hoboken, New Jersey : , : Wiley, , 2017
Descrizione fisica 1 online resource (397 pages)
Disciplina 615.1/9
Soggetto topico Drugs - Design
Pharmaceutical technology - Quality control
ISBN 1-119-35617-2
1-119-35616-4
1-119-35618-0
Formato Materiale a stampa
Livello bibliografico Monografia
Lingua di pubblicazione eng
Record Nr. UNINA-9910270939003321
Hoboken, New Jersey : , : Wiley, , 2017
Materiale a stampa
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Comprehensive quality by design for pharmaceutical product development and manufacture / / edited by Gintaras V. Reklaitis, Salvador Garcia-Munoz, Christine Seymour
Comprehensive quality by design for pharmaceutical product development and manufacture / / edited by Gintaras V. Reklaitis, Salvador Garcia-Munoz, Christine Seymour
Pubbl/distr/stampa Hoboken, New Jersey : , : Wiley, , 2017
Descrizione fisica 1 online resource (397 pages)
Disciplina 615.1/9
Soggetto topico Drugs - Design
Pharmaceutical technology - Quality control
ISBN 1-119-35617-2
1-119-35616-4
1-119-35618-0
Formato Materiale a stampa
Livello bibliografico Monografia
Lingua di pubblicazione eng
Record Nr. UNINA-9910811302803321
Hoboken, New Jersey : , : Wiley, , 2017
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Pharmaceutical manufacturing handbook : regulations and quality / / [edited by] Shayne Cox Gad
Pharmaceutical manufacturing handbook : regulations and quality / / [edited by] Shayne Cox Gad
Pubbl/distr/stampa Hoboken, N.J. : , : Wiley-Interscience, , 2008
Descrizione fisica 1 online resource (857 pages)
Disciplina 615.19
615/.19
Altri autori (Persone) GadShayne C. <1948->
Collana Pharmaceutical Development Series
Soggetto topico Pharmaceutical technology - Quality control
Pharmacy - Law and legislation - United States
Drugs - Law and legislation - United States
ISBN 1-281-23752-3
9786611237523
0-470-25983-3
0-470-25982-5
Formato Materiale a stampa
Livello bibliografico Monografia
Lingua di pubblicazione eng
Nota di contenuto PHARMACEUTICAL MANUFACTURING HANDBOOK Regulations and Quality; CONTRIBUTORS; CONTENTS; PREFACE; SECTION 1 GOOD MANUFACTURING PRACTICES (GMP) AND OTHER FDA GUIDELINES; 1.1 Good Manufacturing Practices (GMPs) and Related FDA Guidelines; 1.2 Enforcement of Current Good Manufacturing Practices; 1.3 Scale-Up and Postapproval Changes (SUPAC) Regulations; 1.4 GMP-Compliant Propagation of Human Multipotent Mesenchymal Stromal Cells; SECTION 2 INTERNATIONAL REGULATIONS OF GOOD MANUFACTURING PRACTICES
2.1 National GMP Regulations and Codes and International GMP Guides and Guildelines: Correspondences and Differences; SECTION 3 QUALITY; 3.1 Analytical and Computational Methods and Examples for Designing and Controlling Total Quality Management Pharmaceutical Manufacturing Systems; 3.2 Role of Quality Systems and Audits in Phatmaceutical Manufacturing Environment; 3.3 Creating and Managing a Quality Management System; 3.4 Quality Process Improvement; SECTION 4 PROCESS ANALYTICAL TECHNOLOGY (PAT); 4.1 Case for Process Analytical Technology: Regulatory and Industrial Perspectives
4.2 Process Analytical Technology; 4.3 Chemical Imaging and Chemometrics: Useful Tools for Process Analytical Technology; SECTION 5 PERSONNEL; 5.1 Personnel Training in Pharmaceutical Manufacturing; SECTION 6 CONTAMINATION AND CONTAMINATION CONTROL; 6.1 Origin of Contamination; 6.2 Quantitation of Markers for Gram-Negative and Gram-Positive Endotoxins in Work Environment and as Contaminants in Pharmaceutical Products Using Gas Chromatography-Tandem Mass Spectrometry; 6.3 Microbiology of Nonsterile Pharmaceutical Manufacturing; SECTION 7 DRUG STABILITY
7.1 Stability and Shelf Life of Pharmaceutical Products; 7.2 Drug Stability; 7.3 Effect of Packaging on Stability of Drugs and Drug Products; 7.4 Pharmaceutical Product Stability; 7.5 Alternative Accelerated Methods for Studying Drug Stability: Variable-Parameter Kinetics; SECTION 8 VALIDATION; 8.1 Analytical Method Validation: Principles and Practices; 8.2 Analytical Method Validation and Quality Assurance; 8.3 Validation of Laboratory Instruments; 8.4 Pharmaceutical Manufacturing Validation Principles; INDEX
Record Nr. UNINA-9910785000603321
Hoboken, N.J. : , : Wiley-Interscience, , 2008
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Pharmaceutical manufacturing handbook : regulations and quality / / [edited by] Shayne Cox Gad
Pharmaceutical manufacturing handbook : regulations and quality / / [edited by] Shayne Cox Gad
Edizione [1st ed.]
Pubbl/distr/stampa Hoboken, N.J., : Wiley-Interscience, c2008
Descrizione fisica 1 online resource (857 pages)
Disciplina 615.19
615/.19
Altri autori (Persone) GadShayne C. <1948->
Collana Pharmaceutical Development Series
Soggetto topico Pharmaceutical technology - Quality control
Pharmacy - Law and legislation - United States
ISBN 9786611237523
9781281237521
1281237523
9780470259832
0470259833
9780470259825
0470259825
Formato Materiale a stampa
Livello bibliografico Monografia
Lingua di pubblicazione eng
Nota di contenuto PHARMACEUTICAL MANUFACTURING HANDBOOK Regulations and Quality; CONTRIBUTORS; CONTENTS; PREFACE; SECTION 1 GOOD MANUFACTURING PRACTICES (GMP) AND OTHER FDA GUIDELINES; 1.1 Good Manufacturing Practices (GMPs) and Related FDA Guidelines; 1.2 Enforcement of Current Good Manufacturing Practices; 1.3 Scale-Up and Postapproval Changes (SUPAC) Regulations; 1.4 GMP-Compliant Propagation of Human Multipotent Mesenchymal Stromal Cells; SECTION 2 INTERNATIONAL REGULATIONS OF GOOD MANUFACTURING PRACTICES
2.1 National GMP Regulations and Codes and International GMP Guides and Guildelines: Correspondences and Differences; SECTION 3 QUALITY; 3.1 Analytical and Computational Methods and Examples for Designing and Controlling Total Quality Management Pharmaceutical Manufacturing Systems; 3.2 Role of Quality Systems and Audits in Phatmaceutical Manufacturing Environment; 3.3 Creating and Managing a Quality Management System; 3.4 Quality Process Improvement; SECTION 4 PROCESS ANALYTICAL TECHNOLOGY (PAT); 4.1 Case for Process Analytical Technology: Regulatory and Industrial Perspectives
4.2 Process Analytical Technology; 4.3 Chemical Imaging and Chemometrics: Useful Tools for Process Analytical Technology; SECTION 5 PERSONNEL; 5.1 Personnel Training in Pharmaceutical Manufacturing; SECTION 6 CONTAMINATION AND CONTAMINATION CONTROL; 6.1 Origin of Contamination; 6.2 Quantitation of Markers for Gram-Negative and Gram-Positive Endotoxins in Work Environment and as Contaminants in Pharmaceutical Products Using Gas Chromatography-Tandem Mass Spectrometry; 6.3 Microbiology of Nonsterile Pharmaceutical Manufacturing; SECTION 7 DRUG STABILITY
7.1 Stability and Shelf Life of Pharmaceutical Products; 7.2 Drug Stability; 7.3 Effect of Packaging on Stability of Drugs and Drug Products; 7.4 Pharmaceutical Product Stability; 7.5 Alternative Accelerated Methods for Studying Drug Stability: Variable-Parameter Kinetics; SECTION 8 VALIDATION; 8.1 Analytical Method Validation: Principles and Practices; 8.2 Analytical Method Validation and Quality Assurance; 8.3 Validation of Laboratory Instruments; 8.4 Pharmaceutical Manufacturing Validation Principles; INDEX
Record Nr. UNINA-9910955154003321
Hoboken, N.J., : Wiley-Interscience, c2008
Materiale a stampa
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Quality assurance journal
Quality assurance journal
Pubbl/distr/stampa [Chichester], : John Wiley & Sons, ©1996-©2011
Descrizione fisica 1 online resource
Disciplina 615
Soggetto topico Pharmaceutical technology - Quality control
Medical instruments and apparatus industry - Quality control
Pollution control industry - Quality control
Medical care - Quality control
Environmental Medicine - standards
Health Occupations - standards
Quality Assurance, Health Care
Techniques pharmaceutiques - Qualité - Contrôle
Médecine - Appareils et instruments - Industrie - Qualité - Contrôle
Environnement - Industrie - Qualité - Contrôle
Soins médicaux - Qualité - Contrôle
Tecnologia farmacèutica
Aparells i instruments mèdics
Control de qualitat
Control de processos
Garantia de qualitat
Soggetto genere / forma Internet resource
Periodicals.
Revistes electròniques.
ISSN 1099-1786
Formato Materiale a stampa
Livello bibliografico Periodico
Lingua di pubblicazione eng
Altri titoli varianti Qual Assur J
QA
Record Nr. UNINA-9910555240803321
[Chichester], : John Wiley & Sons, ©1996-©2011
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Quality by design for biopharmaceuticals [[electronic resource] ] : principles and case studies / / edited by Anurag S. Rathore and Rohin Mhatre
Quality by design for biopharmaceuticals [[electronic resource] ] : principles and case studies / / edited by Anurag S. Rathore and Rohin Mhatre
Pubbl/distr/stampa Hoboken, : Wiley, c2009
Descrizione fisica 1 online resource (326 p.)
Disciplina 615.19
615/.19
Altri autori (Persone) MhatreRohin
RathoreAnurag S <1973-> (Anurag Singh)
Collana Wiley Series in Biotechnology and Bioengineering
Soggetto topico Pharmaceutical biotechnology - Quality control
Pharmaceutical technology - Quality control
Soggetto genere / forma Electronic books.
ISBN 1-118-21091-3
1-282-36843-5
9786612368431
0-470-46631-6
0-470-46630-8
Formato Materiale a stampa
Livello bibliografico Monografia
Lingua di pubblicazione eng
Nota di contenuto QUALITY BY DESIGN FOR BIOPHARMACEUTICALS; CONTENTS; Foreword; Preface; Preface to the Wiley Series on Biotechnology and Related Topics; Contributors; 1 QUALITY BY DESIGN: AN OVERVIEW OF THE BASIC CONCEPTS; 2 CONSIDERATIONS FOR BIOTECHNOLOGY PRODUCT QUALITY BY DESIGN; 3 MOLECULAR DESIGN OF RECOMBINANT MALARIA VACCINES EXPRESSED BY Pichia pastoris; 4 USING A RISK ASSESSMENT PROCESS TO DETERMINE CRITICALITY OF PRODUCT QUALITY ATTRIBUTES; 5 CASE STUDY ON DEFINITION OF PROCESS DESIGN SPACE FOR A MICROBIAL FERMENTATION STEP; 6 APPLICATION OF QbD PRINCIPLES TO TANGENTIAL FLOW FILTRATION OPERATIONS
7 APPLICATIONS OF DESIGN SPACE FOR BIOPHARMACEUTICAL PURIFICATION PROCESSES8 VIRAL CLEARANCE: A STRATEGY FOR QUALITY BY DESIGN AND THE DESIGN SPACE; 9 APPLICATION OF QUALITY BY DESIGN AND RISK ASSESSMENT PRINCIPLES FOR THE DEVELOPMENT OF FORMULATION DESIGN SPACE; 10 APPLICATION OF QbD PRINCIPLES TO BIOLOGICS PRODUCT: FORMULATION AND PROCESS DEVELOPMENT; 11 QbD FOR RAW MATERIALS; 12 PAT TOOLS FOR BIOLOGICS: CONSIDERATIONS AND CHALLENGES; 13 EVOLUTION AND INTEGRATION OF QUALITY BY DESIGN AND PROCESS ANALYTICAL TECHNOLOGY; Index
Record Nr. UNINA-9910139982903321
Hoboken, : Wiley, c2009
Materiale a stampa
Lo trovi qui: Univ. Federico II
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Quality by design for biopharmaceuticals [[electronic resource] ] : principles and case studies / / edited by Anurag S. Rathore and Rohin Mhatre
Quality by design for biopharmaceuticals [[electronic resource] ] : principles and case studies / / edited by Anurag S. Rathore and Rohin Mhatre
Pubbl/distr/stampa Hoboken, : Wiley, c2009
Descrizione fisica 1 online resource (326 p.)
Disciplina 615.19
615/.19
Altri autori (Persone) MhatreRohin
RathoreAnurag S <1973-> (Anurag Singh)
Collana Wiley Series in Biotechnology and Bioengineering
Soggetto topico Pharmaceutical biotechnology - Quality control
Pharmaceutical technology - Quality control
ISBN 1-118-21091-3
1-282-36843-5
9786612368431
0-470-46631-6
0-470-46630-8
Formato Materiale a stampa
Livello bibliografico Monografia
Lingua di pubblicazione eng
Nota di contenuto QUALITY BY DESIGN FOR BIOPHARMACEUTICALS; CONTENTS; Foreword; Preface; Preface to the Wiley Series on Biotechnology and Related Topics; Contributors; 1 QUALITY BY DESIGN: AN OVERVIEW OF THE BASIC CONCEPTS; 2 CONSIDERATIONS FOR BIOTECHNOLOGY PRODUCT QUALITY BY DESIGN; 3 MOLECULAR DESIGN OF RECOMBINANT MALARIA VACCINES EXPRESSED BY Pichia pastoris; 4 USING A RISK ASSESSMENT PROCESS TO DETERMINE CRITICALITY OF PRODUCT QUALITY ATTRIBUTES; 5 CASE STUDY ON DEFINITION OF PROCESS DESIGN SPACE FOR A MICROBIAL FERMENTATION STEP; 6 APPLICATION OF QbD PRINCIPLES TO TANGENTIAL FLOW FILTRATION OPERATIONS
7 APPLICATIONS OF DESIGN SPACE FOR BIOPHARMACEUTICAL PURIFICATION PROCESSES8 VIRAL CLEARANCE: A STRATEGY FOR QUALITY BY DESIGN AND THE DESIGN SPACE; 9 APPLICATION OF QUALITY BY DESIGN AND RISK ASSESSMENT PRINCIPLES FOR THE DEVELOPMENT OF FORMULATION DESIGN SPACE; 10 APPLICATION OF QbD PRINCIPLES TO BIOLOGICS PRODUCT: FORMULATION AND PROCESS DEVELOPMENT; 11 QbD FOR RAW MATERIALS; 12 PAT TOOLS FOR BIOLOGICS: CONSIDERATIONS AND CHALLENGES; 13 EVOLUTION AND INTEGRATION OF QUALITY BY DESIGN AND PROCESS ANALYTICAL TECHNOLOGY; Index
Record Nr. UNINA-9910831067203321
Hoboken, : Wiley, c2009
Materiale a stampa
Lo trovi qui: Univ. Federico II
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Quality by design for biopharmaceuticals : principles and case studies / / edited by Anurag S. Rathore and Rohin Mhatre
Quality by design for biopharmaceuticals : principles and case studies / / edited by Anurag S. Rathore and Rohin Mhatre
Pubbl/distr/stampa Hoboken, : Wiley, c2009
Descrizione fisica 1 online resource (326 p.)
Disciplina 615/.19
Altri autori (Persone) MhatreRohin
RathoreAnurag S <1973-> (Anurag Singh)
Collana Wiley Series in Biotechnology and Bioengineering
Soggetto topico Pharmaceutical biotechnology - Quality control
Pharmaceutical technology - Quality control
ISBN 9786612368431
9781118210918
1118210913
9781282368439
1282368435
9780470466315
0470466316
9780470466308
0470466308
Formato Materiale a stampa
Livello bibliografico Monografia
Lingua di pubblicazione eng
Nota di contenuto QUALITY BY DESIGN FOR BIOPHARMACEUTICALS; CONTENTS; Foreword; Preface; Preface to the Wiley Series on Biotechnology and Related Topics; Contributors; 1 QUALITY BY DESIGN: AN OVERVIEW OF THE BASIC CONCEPTS; 2 CONSIDERATIONS FOR BIOTECHNOLOGY PRODUCT QUALITY BY DESIGN; 3 MOLECULAR DESIGN OF RECOMBINANT MALARIA VACCINES EXPRESSED BY Pichia pastoris; 4 USING A RISK ASSESSMENT PROCESS TO DETERMINE CRITICALITY OF PRODUCT QUALITY ATTRIBUTES; 5 CASE STUDY ON DEFINITION OF PROCESS DESIGN SPACE FOR A MICROBIAL FERMENTATION STEP; 6 APPLICATION OF QbD PRINCIPLES TO TANGENTIAL FLOW FILTRATION OPERATIONS
7 APPLICATIONS OF DESIGN SPACE FOR BIOPHARMACEUTICAL PURIFICATION PROCESSES8 VIRAL CLEARANCE: A STRATEGY FOR QUALITY BY DESIGN AND THE DESIGN SPACE; 9 APPLICATION OF QUALITY BY DESIGN AND RISK ASSESSMENT PRINCIPLES FOR THE DEVELOPMENT OF FORMULATION DESIGN SPACE; 10 APPLICATION OF QbD PRINCIPLES TO BIOLOGICS PRODUCT: FORMULATION AND PROCESS DEVELOPMENT; 11 QbD FOR RAW MATERIALS; 12 PAT TOOLS FOR BIOLOGICS: CONSIDERATIONS AND CHALLENGES; 13 EVOLUTION AND INTEGRATION OF QUALITY BY DESIGN AND PROCESS ANALYTICAL TECHNOLOGY; Index
Record Nr. UNINA-9911020439003321
Hoboken, : Wiley, c2009
Materiale a stampa
Lo trovi qui: Univ. Federico II
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Regulated bioanalytical laboratories : technical and regulatory aspects from global perspectives / / Michael Zhou
Regulated bioanalytical laboratories : technical and regulatory aspects from global perspectives / / Michael Zhou
Autore Zhou Michael
Pubbl/distr/stampa Hoboken, N.J., : Wiley, c2011
Descrizione fisica 1 online resource (548 p.)
Disciplina 610.28/4
Soggetto topico Medical laboratories - Quality control
Biological laboratories - Quality control
Pharmaceutical technology - Quality control
ISBN 9786612889059
9780470922804
047092280X
9781282889057
1282889052
9780470920671
047092067X
9780470920664
0470920661
Formato Materiale a stampa
Livello bibliografico Monografia
Lingua di pubblicazione eng
Nota di contenuto REGULATED BIOANALYTICAL LABORATORIES: Technical and Regulatory Aspects from Global Perspectives; CONTENTS; PREFACE; ACKNOWLEDGMENT; CONTRIBUTORS AND ADVISORS; 1 INTRODUCTION, OBJECTIVES, AND KEY REQUIREMENTS FOR GLP REGULATIONS; 1.1 INTRODUCTION; 1.1.1 Good Laboratory Practices; 1.1.2 Bioanalytical Laboratories-Bioanalysis; 1.1.3 Good Laboratory Practices Versus Bioanalytical Labs/Bioanalysis; 1.2 OBJECTIVES AND KEY REQUIREMENTS FOR GLP REGULATIONS; 1.3 FUNDAMENTAL UNDERSTANDING OF GLP REGULATIONS AND PRINCIPLES; 1.3.1 Elements of Good Laboratory Practices
1.4 KEY ELEMENTS OF BIOANALYTICAL METHODS VALIDATION1.4.1 Reference Standards; 1.4.2 Method Development-Chemical/Chromatographic Assay; 1.4.3 Calibration/Standard Curve; 1.4.4 Stability; 1.4.5 Reproducibility; 1.4.6 Robustness or Ruggedness; 1.5 BASIC PRINCIPLES OF BIOANALYTICAL METHOD VALIDATION AND ESTABLISHMENT; 1.5.1 Specific Recommendations for Method Validation; 1.5.2 Acceptance Criteria for Analytical Run; REFERENCES; 2 HISTORIC PERSPECTIVES OF GLP REGULATIONS, APPLICABILITY, AND RELATION TO OTHER REGULATIONS; 2.1 HISTORIC PERSPECTIVES OF GLP REGULATIONS; 2.1.1 Economic Assessment
2.1.2 Environmental Impact2.2 APPLICABILITY AND RELATIONS TO OTHER REGULATIONS/ PRINCIPLES; 2.2.1 GLP, GCP, GMP, and Part 11; 2.2.2 General Terminologies and Definitions of GxPs (GLP, GCP, and cGMP); 2.3 COMPARISON OF FDA GLP, EPA GLP REGULATIONS, AND OECD GLP PRINCIPLES; 2.3.1 US and OECD GLP Similarity and Differences; 2.4 APPLICATIONS OF GLP TO MULTIPLE SITE STUDIES; 2.4.1 Roles and Responsibilities; 2.4.2 Performance of the Studies; 2.4.3 Applications of GLP to In Vitro Studies for Regulatory Submissions; 2.5 21 CFR PART 11 IN RELATION TO GLP PROGRAMS; 2.5.1 A New Risk-Based Approach
2.5.2 Understanding Predicate Rule Requirements2.5.3 21 CFR Part 11 Best Practices; 2.5.4 Use of Electronic Signatures; 2.6 GLP, cGMP, AND ISO APPLICABILITIES, SIMILARITY, AND DIFFERENCES; 2.6.1 GLPs, cGMPs, ISO 17025:2005: How Do They Differ?; 2.6.2 GLPs Versus GMPs; 2.6.3 GLPs Versus ISO/IEC 17025:2005; 2.6.4 ISO Versus GLPs; 2.7 GOOD CLINICAL PRACTICES AND GOOD CLINICAL LABORATORY PRACTICES; 2.8 GAP AND CURRENT INITIATIVES ON REGULATING LABORATORY ANALYSIS IN SUPPORT OF CLINICAL TRIALS; REFERENCES; 3 GLP QUALITY SYSTEM AND IMPLEMENTATION; 3.1 GLP QUALITY SYSTEM
3.1.1 Regulatory Inspection for GLP Quality System3.1.2 Good Laboratory Practice Inspections; 3.1.3 GLP Quality System Objectives; 3.2 GLOBAL GLP REGULATIONS AND PRINCIPLES; 3.2.1 General; 3.2.2 Responsibilities and Compliance; 3.2.3 Statement of Compliance in the Final Report; 3.2.4 Protocol Approval; 3.2.5 Assignment of Study Director; 3.2.6 Laboratory Qualification/Certification; 3.2.7 Authority Inspections; 3.2.8 Archiving Requirements; 3.3 IMPLEMENTATION OF GLP REGULATIONS AND OECD PRINCIPLES; 3.3.1 Planning (Master Schedule); 3.3.2 Personnel Organization; 3.3.3 Curriculum Vitae
3.3.4 Rules of the Conducts of Studies
Record Nr. UNINA-9911019143503321
Zhou Michael  
Hoboken, N.J., : Wiley, c2011
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