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Essential Elements for a GMP Analytical Chemistry Department.
Essential Elements for a GMP Analytical Chemistry Department is a systematic approach to understanding the essential elements required for a successful GMP Analytical Department to function as an efficient and effective organization. It describes in detail a department structure which allows for the...
| Clasificación: | Libro Electrónico |
|---|---|
| Autor principal: | |
| Formato: | Electrónico eBook |
| Idioma: | Inglés |
| Publicado: |
Dordrecht :
Springer,
2013.
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| Temas: | |
| Acceso en línea: | Texto completo |
Tabla de Contenidos:
- 312574_1_En_BookFrontmatter_OnlinePDF; Preface; Contents; Abbreviations; 1 Introduction; 2 Organization; Abstract; 2.1 ... Department StructureDepartment Structure; 2.2 ... Project TeamsProject Teams; 2.2.1 Project Team Development and Management; 2.2.2 Risk EvaluationRisk Evaluation; 2.2.3 Project Team DynamicsProject Team Dynamics; 2.2.3.1 The Teams Leader Role is as Follows; 2.2.3.2 The Team Member Role is as Follows; 2.2.3.3 Brainstorming ProcessBrainstorming Process; 2.2.3.4 Rounds of ReasoningRounds of Reasoning; 2.2.3.5 Clarifying Question.
- 2.2.3.6 Highest Level of AuthorityHighest level of Authority2.2.3.7 Modes of DecisionModes of Decision Making; 2.2.3.8 Use of ConsensusUse of Consensus; 2.2.3.9 ScribeScribe; 2.2.3.10 FacilitationFacilitation; 2.2.3.11 GovernanceGovernance [2]; 2.3 ... Responsibilities; 2.4 ... Interactions [3]; 2.5 ... Operating Guidance'sOperating Guidance's; 2.5.1 SOP's and Guidelines; 2.5.1.1 Laboratory OperationsLaboratory Operations; 2.5.1.2 Department PoliciesDepartment Policies; 2.5.1.3 Management ControlManagement Control; 2.5.2 Regulatory Guidance's; References; 3 Processes; Abstract.
- 3.1 ... Safety ProcessSafety Process3.2 ... Technology ProcessesTechnology Processes; 3.2.1 Systematic Approach to HPLC Method DevelopmentHPLC Method Development [1, 2]; 3.2.2 Dissolution Method DevelopmentDissolution Method Development; 3.2.3 Systematic Approach to Method ValidationMethod Validation; 3.2.4 Analytical Technology TransferTechnology Transfer Process; 3.3 ... Departmental Processes; 3.3.1 Specification DevelopmentSpecification Development Process; 3.3.2 Stability ManagementStability Management Process [9]; 3.3.3 Reference Standard CertificationReference Standard Certification Process [11].
- 3.3.4 TrainingTraining [12]References; 4 Statistical Concepts for the Analytical Chemist; Abstract; 4.1 ... Distribution; 4.1.1 Student's t DistributionStudent's t distribution; 4.1.2 Chi-Squared DistributionChi-squared distribution {{\usertwo (x^{2})}}; 4.1.3 The F DistributionF distribution; 4.2 ... Significance TestingSignificance Testing; 4.2.1 Arithmetic MeanArithmetic Mean; 4.2.2 MedianMedian; 4.2.3 Standard DeviationStandard Deviation; 4.2.4 Standard Error of the MeanStandard Error of the Mean; 4.2.5 Relative Standard DeviationRelative Standard Deviation (Coefficient of Variation).
- 4.2.6 Hypotheses4.2.7 Significant Testing [3]; 4.3 ... Confidence IntervalsConfidence Intervals for the Mean [4]; 4.4 ... OutlierOutliers in Analytical Data [4]; 4.5 ... Regression Analysis [5]; 4.6 ... Design of Experiments [6
- 8]; 4.7 ... Required Sample Replicates [4]Sample Replicates; 4.8 ... Method Performance; 4.8.1 Method PrecisionMethod Precision [4]; 4.8.2 AccuracyAccuracy; 4.8.3 Linearity [1, 4]; 4.8.4 Limit of Detection (LOD)Limit of detection (LOD) [4]; 4.8.5 Limit of Quantitation (LOQ)Limit of Quantitation (LOQ); 4.8.6 RuggednessRuggedness [8, 9].