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240528t20242024si |||||o|||||||||||eng d |
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|a EIZ
|b 333
|c EBSCO trvale nakupy
|d 2024-05-28
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|a 978-981-99-9271-3
|q (eBook)
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|a (OCoLC)on1427062872
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|a (OCoLC)1427062872
|z (OCoLC)1426287329
|z (OCoLC)1430332014
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|a EBLCP
|b cze
|e rda
|c EBLCP
|d GW5XE
|d YDX
|d EBLCP
|d OCLCO
|d OCLCQ
|d QGK
|d N$T
|d BOD037
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|a 615
|x Farmacie. Farmakologie
|2 Konspekt
|9 14
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|a 615:54
|2 MRF
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|a 615:338.45
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|a (048.8:082)
|2 MRF
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|a Modern aspects of pharmaceutical quality assurance :
|b developing & proposing application models, SOPs, practical audit systems for pharma industry /
|c Minal Ghante, Manohar Potdar, Vidhya Bhusari, editors
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|a Singapore :
|b Springer,
|c [2024]
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| 264 |
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|c ©2024
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| 300 |
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|a 1 online zdroj (viii, 523 stran) :
|b ilustrace
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|a text
|b txt
|2 rdacontent
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|a počítač
|b c
|2 rdamedia
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|a online zdroj
|b cr
|2 rdacarrier
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|a Intro -- Preface -- Contents -- Chapter 1: Introduction: Quality Assurance from Perspective of Pharmaceutical Industry -- 1.1 Introduction -- References -- Chapter 2: Six Sigma Model in Pharma Industry: Part -- I -- 2.1 Six Sigma Part -- I -- 2.1.1 Introduction -- 2.2 Six Sigma -- 2.3 Six Sigma Methodology -- 2.4 Lean Six Sigma (LSS) -- 2.5 Six Sigma Vs. Lean Vs. cGMP -- References -- Chapter 3: Six-Sigma Model in Pharma Industry: Part -- II -- 3.1 Six Sigma: Part-II -- 3.1.1 Conception of the Six Sigma Principles -- 3.1.2 Quality by Design (QbD) -- 3.1.3 Elements of QbD
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|a 3.1.3.1 Quality Target Product Profile (QTPP) Which Recognizes Critical Quality Attributes (CQA) of Product -- 3.1.3.2 Identification of Critical Material Attributes (CMA) -- 3.1.3.3 Critical Process Parameters (CPP) Process Design as Well as Understanding (Strong Understanding of Scale-Up Techniques... -- 3.1.3.4 Control Strategy -- 3.1.3.5 Process Capability and Continuous Improvement -- 3.1.4 Pillars of QbD -- 3.1.4.1 Design Space(DS) -- 3.1.4.2 Control Space(CS)/DOE -- 3.1.4.3 Operating Space (OS) -- 3.1.5 QBD Methodology and Tools -- 3.1.5.1 Risk Assessment (RA)
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|a 3.1.5.2 Design of Experiment (DoE) -- 3.1.6 Types of DoE -- 3.1.6.1 Newly Arising Technologies -- 3.1.7 Process Analytical Technology (PAT) -- 3.1.8 PAT Components -- 3.1.8.1 Multivariate Statistical Process Control -- 3.1.8.2 Continuous Process Optimization and Knowledge Management -- 3.1.8.3 Process Analytical Chemistry Tools -- 3.1.8.4 Process Monitoring and Control -- 3.1.9 PAT Techniques -- 3.1.10 Continuous Manufacturing (CM) -- 3.1.10.1 Collaborative Continuous and End-to-End (E2E) Manufacturing -- 3.1.10.2 What Can Industry and Company Do? -- 3.2 Digitalization and Digital Twins
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|a 3.2.1 Industrial Revolutions and Industry 4.0 -- 3.2.1.1 Birth of Industry 5.0 -- 3.2.2 3D, 4D, and 5D Printing -- 3.2.2.1 3D -- 3.2.2.2 Pros of 3D Printing -- 3.2.2.3 4D -- 3.2.2.4 5D -- 3.2.3 Artificial Intelligence (AI), Image Analysis (IA), and Machine Learning (ML) Including Deep Learning (DL) -- 3.2.4 Supply Chain Management and Green Supply Chain Management -- 3.2.4.1 Operational Excellence -- Continuous Improvement (CI) -- References -- Chapter 4: Developing a Practical Audit System for a Pharmaceutical Industry Based on Six System Inspection Model -- 4.1 Introduction
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|a 4.1.1 Production System -- 4.1.2 Facilities and Equipment System -- 4.1.3 Laboratory Control System -- 4.1.4 Materials System -- 4.1.5 Packaging and Labeling System -- 4.1.6 Quality System -- 4.2 Consolidated Information -- 4.3 Development of Seventh System -- 4.3.1 Promote Improvement [ISO-10.3] -- 4.4 Audit and Checklist Format -- References -- Chapter 5: Compliance Tools to Assist the Drug Industry for Regulatory Audits from Developed Countries -- 5.1 Introduction -- 5.1.1 Regulatory Audits -- 5.1.2 Types of Audits -- 5.1.3 The Ten Steps in the Pharma Audit Process -- 5.1.4 Remote Auditing
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| 533 |
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|a Elektronická reprodukce.
|n Přístup pouze pro oprávněné uživatele
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| 650 |
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|a farmaceutická chemie
|7 ph114523
|2 czenas
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| 650 |
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|a farmaceutický průmysl
|7 ph120140
|2 czenas
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| 650 |
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|a systémy cílené aplikace léků
|2 czmesh
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| 650 |
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|a pharmaceutical chemistry
|2 eczenas
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| 650 |
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|a pharmaceutical industry
|2 eczenas
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| 650 |
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|a Drug Delivery Systems
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| 655 |
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|a e-knihy online
|2 CZ-BrMU
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| 655 |
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|a kolektivní monografie
|7 fd501537
|2 czenas
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| 655 |
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9 |
|a e-books online
|2 eCZ-BrMU
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| 655 |
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9 |
|a collective monographs
|2 eczenas
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| 700 |
1 |
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|a Ghante, Minal
|4 edt
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| 700 |
1 |
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|a Potdar, Manohar
|4 edt
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| 700 |
1 |
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|a Bhusari, Vidhya
|4 edt
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| 776 |
0 |
8 |
|i Tištěná verze:
|t Modern aspects of pharmaceutical quality assurance
|z 978-981-99-9270-6
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| 856 |
4 |
1 |
|z Elektronická verze přístupná pouze pro studenty a pracovníky MU
|u https://search.ebscohost.com/login.aspx?direct=true&scope=site&db=nlebk&AN=3850018
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