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Laboratory control system operations in a GMP environment / / David M. Bliesner
| Laboratory control system operations in a GMP environment / / David M. Bliesner |
| Autore | Bliesner David M. |
| Pubbl/distr/stampa | Hoboken, New Jersey : , : Wiley, , [2020] |
| Descrizione fisica | 1 online resource (xvii, 302 pages) |
| Disciplina | 362.177 |
| Soggetto topico | Medical laboratories - Quality control |
| Soggetto genere / forma | Electronic books. |
| ISBN |
1-119-52929-8
1-119-52927-1 1-119-52919-0 |
| Formato | Materiale a stampa  |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Record Nr. | UNINA-9910554866003321 |
Bliesner David M.
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| Hoboken, New Jersey : , : Wiley, , [2020] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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Laboratory control system operations in a GMP environment / / David M. Bliesner
| Laboratory control system operations in a GMP environment / / David M. Bliesner |
| Autore | Bliesner David M. |
| Pubbl/distr/stampa | Hoboken, New Jersey : , : Wiley, , [2020] |
| Descrizione fisica | 1 online resource (xvii, 302 pages) |
| Disciplina | 362.177 |
| Soggetto topico | Medical laboratories - Quality control |
| ISBN |
1-119-52929-8
1-119-52927-1 1-119-52919-0 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | Introduction to the quality systems based approach to CGMP compliance -- Components of the laboratory managerial and administrative systems sub element (MS) -- Components of the laboratory documentation practices and standard operating procedures sub element (OP) -- Components of the laboratory equipment sub element (Le) -- Components of the laboratory facilities sub element (LF) -- Components of the method validation and method transfer sub element (MV) -- Components of the laboratory computer systems sub element (LC) -- Components of the laboratory investigations sub element (Li) -- Components of the laboratory data governance and data integrity sub element (DI) -- Components of the stability program sub element (SB) -- Components of the general laboratory compliance practices sub element (CP) -- Summary for establishing and maintaining a laboratory control system. |
| Record Nr. | UNINA-9910830920603321 |
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Bliesner David M.
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| Hoboken, New Jersey : , : Wiley, , [2020] | ||
| 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 |
0-470-92280-X
1-282-88905-2 9786612889059 0-470-92067-X 0-470-92066-1 |
| 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-9910876788003321 |
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Zhou Michael
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| Hoboken, N.J., : Wiley, c2011 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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The role of the study director in nonclinical studies : pharmaceuticals, chemicals, medical devices, and pesticides / / edited by William J. Brock ; associate editors Barbara J. Mounho, Lijie Fu
| The role of the study director in nonclinical studies : pharmaceuticals, chemicals, medical devices, and pesticides / / edited by William J. Brock ; associate editors Barbara J. Mounho, Lijie Fu |
| Pubbl/distr/stampa | Hoboken, New Jersey : , : John Wiley & Sons, , 2014 |
| Descrizione fisica | 1 online resource (570 p.) |
| Disciplina | 616.07/5 |
| Soggetto topico |
Medical laboratories - Quality control
Biological laboratories - Quality control Health occupations schools Allied health personnel - In-service training |
| ISBN |
1-118-87392-0
1-118-87390-4 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
Cover; Title page; Copyright page; Contents; Foreword; Preface; Contributors; 1: Introduction to the Study Director; 1.1 Definition of Study Director; 1.2 Regulatory History on the Scope of the Role; 1.2.1 FDA 1976 Proposed Rule (41 FR 1976); 1.2.2 FDA 1978 Final Rule (43 FR 1978); 1.2.3 OECD Consensus Document 1999 (OECD, 1999); 1.3 Guidance on Study Director Qualifications and Training; 1.3.1 OECD on Qualifications of the Study Director; 1.3.2 OECD on Training of Study Directors; 1.4 Study Director Training Courses; 1.5 Summary; References
2: Good Laboratory Practice Regulations: Roles of the Study Director, Management, and Quality Assurance Unit2.1 Introduction and Objectives; 2.2 Regulation Attempts Prior to 1930; 2.3 Critical Events Leading to Regulations; 2.4 Nonclinical Regulation; 2.5 The Purpose of GLP Regulation; 2.6 Industry Benefits of the GLP; 2.7 Requirements of the GLP; 2.8 The Role of Management; 2.9 The Role of the Study Director; 2.10 The Role of the Quality Assurance Unit; 2.11 A Brief Word about the Multi-site GLP Study; 2.12 GLP Interpretation Guidance; 2.13 FDA Concerns and the Future 2.14 Comparing GLP Standards: FDA, EPA, and OECD2.15 Summary; References; 3: International Guidelines and Regulations of Nonclinical Studies; 3.1 General Introduction; 3.2 Scope; 3.3 Legislation, Guidelines, and Regulations; 3.3.1 General; 3.3.2 Globally Acting Organizations; 3.3.3 Region-Specific Regulations; 3.4 Studies; 3.4.1 Screening Information Dataset (SIDS) Dossier; 3.4.2 REACH Data Requirements (Tiers 1-3); 3.4.3 A Discussion on Weight of Evidence and Klimisch Codes; 3.5 Summary; References; 4: Facilities, Operations, Laboratory Animal Care, and Veterinary Services; 4.1 Introduction 4.1.1 Regulatory Oversight and Accreditation Requirements4.1.2 Interaction between GLP and Animal Welfare Regulations; 4.1.3 Control of Study Variables; 4.2 Facilities; 4.2.1 Organization, Personnel, and Management; 4.2.2 Job Descriptions, Training Records, Curriculum Vitae (CV), and Organizational Charts; 4.2.3 Test Facility Design, Construction, and Maintenance; 4.2.4 Formulation Preparation Facilities; 4.2.5 Test and Control Articles; 4.2.6 Specialty Laboratories; 4.2.7 Quality Assurance Unit (QAU): Role and Responsibilities; 4.3 Laboratory Operations 4.3.1 Standard Operating Procedures (SOPs)4.3.2 Reagents and Solutions; 4.3.3 Laboratory Systems and Electronic Records; 4.3.4 Laboratory Instrumentation/Equipment; 4.3.5 Emergency Disaster Plan; 4.4 Laboratory Animal Care and Veterinary Services; 4.4.1 Regulatory Oversight and Accreditation; 4.4.2 Animal Care Facilities; 4.4.3 Animal Health and Veterinary Services Program; 4.4.4 Health Maintenance Program; 4.4.5 Veterinary Services Program; 4.4.6 Veterinary and Animal Care Procedures; 4.5 Other Species; References; 5: Regulatory Inspections; 5.1 Introduction 5.2 Purpose and Types of Regulatory Inspections |
| Record Nr. | UNINA-9910132202203321 |
| Hoboken, New Jersey : , : John Wiley & Sons, , 2014 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
The role of the study director in nonclinical studies : pharmaceuticals, chemicals, medical devices, and pesticides / / edited by William J. Brock ; associate editors Barbara J. Mounho, Lijie Fu
| The role of the study director in nonclinical studies : pharmaceuticals, chemicals, medical devices, and pesticides / / edited by William J. Brock ; associate editors Barbara J. Mounho, Lijie Fu |
| Pubbl/distr/stampa | Hoboken, New Jersey : , : John Wiley & Sons, , 2014 |
| Descrizione fisica | 1 online resource (570 p.) |
| Disciplina | 616.07/5 |
| Soggetto topico |
Medical laboratories - Quality control
Biological laboratories - Quality control Health occupations schools Allied health personnel - In-service training |
| ISBN |
1-118-87392-0
1-118-87390-4 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
Cover; Title page; Copyright page; Contents; Foreword; Preface; Contributors; 1: Introduction to the Study Director; 1.1 Definition of Study Director; 1.2 Regulatory History on the Scope of the Role; 1.2.1 FDA 1976 Proposed Rule (41 FR 1976); 1.2.2 FDA 1978 Final Rule (43 FR 1978); 1.2.3 OECD Consensus Document 1999 (OECD, 1999); 1.3 Guidance on Study Director Qualifications and Training; 1.3.1 OECD on Qualifications of the Study Director; 1.3.2 OECD on Training of Study Directors; 1.4 Study Director Training Courses; 1.5 Summary; References
2: Good Laboratory Practice Regulations: Roles of the Study Director, Management, and Quality Assurance Unit2.1 Introduction and Objectives; 2.2 Regulation Attempts Prior to 1930; 2.3 Critical Events Leading to Regulations; 2.4 Nonclinical Regulation; 2.5 The Purpose of GLP Regulation; 2.6 Industry Benefits of the GLP; 2.7 Requirements of the GLP; 2.8 The Role of Management; 2.9 The Role of the Study Director; 2.10 The Role of the Quality Assurance Unit; 2.11 A Brief Word about the Multi-site GLP Study; 2.12 GLP Interpretation Guidance; 2.13 FDA Concerns and the Future 2.14 Comparing GLP Standards: FDA, EPA, and OECD2.15 Summary; References; 3: International Guidelines and Regulations of Nonclinical Studies; 3.1 General Introduction; 3.2 Scope; 3.3 Legislation, Guidelines, and Regulations; 3.3.1 General; 3.3.2 Globally Acting Organizations; 3.3.3 Region-Specific Regulations; 3.4 Studies; 3.4.1 Screening Information Dataset (SIDS) Dossier; 3.4.2 REACH Data Requirements (Tiers 1-3); 3.4.3 A Discussion on Weight of Evidence and Klimisch Codes; 3.5 Summary; References; 4: Facilities, Operations, Laboratory Animal Care, and Veterinary Services; 4.1 Introduction 4.1.1 Regulatory Oversight and Accreditation Requirements4.1.2 Interaction between GLP and Animal Welfare Regulations; 4.1.3 Control of Study Variables; 4.2 Facilities; 4.2.1 Organization, Personnel, and Management; 4.2.2 Job Descriptions, Training Records, Curriculum Vitae (CV), and Organizational Charts; 4.2.3 Test Facility Design, Construction, and Maintenance; 4.2.4 Formulation Preparation Facilities; 4.2.5 Test and Control Articles; 4.2.6 Specialty Laboratories; 4.2.7 Quality Assurance Unit (QAU): Role and Responsibilities; 4.3 Laboratory Operations 4.3.1 Standard Operating Procedures (SOPs)4.3.2 Reagents and Solutions; 4.3.3 Laboratory Systems and Electronic Records; 4.3.4 Laboratory Instrumentation/Equipment; 4.3.5 Emergency Disaster Plan; 4.4 Laboratory Animal Care and Veterinary Services; 4.4.1 Regulatory Oversight and Accreditation; 4.4.2 Animal Care Facilities; 4.4.3 Animal Health and Veterinary Services Program; 4.4.4 Health Maintenance Program; 4.4.5 Veterinary Services Program; 4.4.6 Veterinary and Animal Care Procedures; 4.5 Other Species; References; 5: Regulatory Inspections; 5.1 Introduction 5.2 Purpose and Types of Regulatory Inspections |
| Record Nr. | UNINA-9910812525303321 |
| Hoboken, New Jersey : , : John Wiley & Sons, , 2014 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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