Essential Elements for a GMP Analytical Chemistry Department.

Saved in:
Bibliographic Details
Main Author: Catalano, Thomas
Format: eBook
Language:English
Published: Dordrecht : Springer, 2013.
Subjects:
Online Access:Click for online access

MARC

LEADER 00000cam a2200000Mu 4500
001 ocn854976001
003 OCoLC
005 20250225213021.0
006 m o d
007 cr |n|||||||||
008 130803s2013 ne o 000 0 eng d
040 |a EBLCP  |b eng  |e pn  |c EBLCP  |d OCLCQ  |d UUM  |d OCLCO  |d OCLCF  |d OCLCQ  |d OCLCO  |d OCLCQ  |d OCLCO  |d OCLCQ  |d OCLCO  |d OCLCL  |d SXB 
020 |a 9781461476429 
020 |a 1461476429 
035 |a (OCoLC)854976001 
050 4 |a RS189 
049 |a HCDD 
100 1 |a Catalano, Thomas. 
245 1 0 |a Essential Elements for a GMP Analytical Chemistry Department. 
260 |a Dordrecht :  |b Springer,  |c 2013. 
300 |a 1 online resource (202 pages) 
336 |a text  |b txt  |2 rdacontent 
337 |a computer  |b c  |2 rdamedia 
338 |a online resource  |b cr  |2 rdacarrier 
505 0 |a 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. 
505 8 |a 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. 
505 8 |a 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]. 
505 8 |a 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). 
505 8 |a 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]. 
500 |a 4.9 ... Measurement UncertaintyMeasurement Uncertainty [4, 10]. 
520 |a 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 necessary processes to become available to all its personnel in a way where there is a free flow of information and interaction. The environment and culture created by this approach encourages and rewards the sharing of ideas, skills, and abilities among department personnel. The essential element. 
588 0 |a Print version record. 
650 0 |a Medicine. 
650 0 |a Pharmaceutical biotechnology. 
650 7 |a medicines (material)  |2 aat 
650 7 |a medicine (discipline)  |2 aat 
650 7 |a Medicine  |2 fast 
650 7 |a Pharmaceutical biotechnology  |2 fast 
758 |i has work:  |a Essential elements for a GMP analytical chemistry department (Text)  |1 https://id.oclc.org/worldcat/entity/E39PCGyFrpCb4V34XypdR3pGjK  |4 https://id.oclc.org/worldcat/ontology/hasWork 
776 0 8 |i Print version:  |a Catalano, Thomas.  |t Essential Elements for a GMP Analytical Chemistry Department.  |d Dordrecht : Springer, ©2013  |z 9781461476412 
856 4 0 |u https://ebookcentral.proquest.com/lib/holycrosscollege-ebooks/detail.action?docID=1317545  |y Click for online access 
903 |a EBC-AC 
994 |a 92  |b HCD