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04729pam a2200541 i 4500 |
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20191205134318.0 |
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|a 017889120
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|a 0128096535
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|a 9780128096536
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|z 012804148X
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|z 9780128041482
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|a (OCoLC)951712418
|z (OCoLC)951977754
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|a 338.476151
|2 23
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| 100 |
1 |
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|a Ostrove, Steve,
|e author.
|9 38020
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| 245 |
1 |
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|a How to validate a pharmaceutical process /
|c Steven A. Ostrove.
|h [electronic resource]
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| 260 |
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1 |
|a London, UK :
|b Elsevier,
|c 2016.
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| 300 |
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|a 1 online resource
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| 500 |
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|a <strong>Off-Campus Access:</strong> Athens ID and Password Required
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| 500 |
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|a <strong>On-Campus Access:</strong> No User ID or Password Required
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| 500 |
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|a Includes index.
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0 |
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|a Front Cover; How to Validate a Pharmaceutical Process; Copyright Page; Dedication; Contents; Author Biography; Preface; Acknowledgment; About the Expertise in the Pharmaceutical Process Technology Series; Format; Subject Matter; Target Audience; I: Introduction to Process Validation; 1 Introduction to Process Validation (PV); Defining Process Validation (PV); Legacy Products; Stages of PV; Notes; 2 A Brief Review of the Regulations; Notes; 3 The Validation Life Cycle and Change Control; Life Cycle Approach; The Role of Change Control; Types of Changes; The Change Control Process; Notes.
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|a 11 Cleaning and Facility QualificationFacility Design; Introduction to Cleaning; General Cleaning Considerations; Facility Design and Cleaning; Equipment Cleaning; Other Cleaning Considerations; Notes; Terms and Definitions; Appendix A: 21 CFR 211; Appendix B: Example-Short Change Control Form; Appendix C: Additional ICH and FDA Guidelines; Important ICH and FDA Guidelines; Index; Back Cover.
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|a II: Stage I-Process Development4 Getting Started; Before It All Starts; Example; Getting Started (After the Equipment Specifications); The Validation Master Plan; Standard Operating Procedures (SOPs) Preparation; Quality Programs; Training; Basic Risk Approach; Putting it Together; Notes; 5 Basic Equipment and Utility Qualification; Introduction; Determining the Level of Qualification; Factory Acceptance Test and Site Acceptance Test; Commissioning; Qualification Protocols-Installation Qualification (IQ) and Operational Qualification (OQ); Performance Qualification.
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| 505 |
8 |
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|a Laboratory Equipment Qualification (EQ)Qualification Protocol Execution; Reports; Calibration and Preventive Maintenance Programs; Notes; 6 Computers and Automated Systems; Introduction; General Considerations; Documentation; Testing; Basic CSV-Black Box-Gray Box-White Box Testing; Computer Life Cycle; Specific Systems; Microprocessors; Programmable Logic Controllers (PLCs); Personal Computers; Networks; Supervisory Control and Data Acquisition (SCADA); Distributed Control Systems (DCS); Part 11; Notes; III: Stage II-Process Development; 7 Process Development; Preliminaries; Development.
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|a Risk AssessmentProcess Parameters; Setting Process Limits; Next Steps; Notes; 8 The Process Validation Protocol-PPQ; Introduction; Setting Protocol Test Ranges; Preparing the Protocol; Executing the Protocol; Sampling Plans; Recording the Results; The Validation Report; Notes; 9 Dealing With Deviations; The Investigation; Notes; IV: Stage III-Continued Process Verification; 10 Stage III-Collection and Evaluating Production Data; General Approach; Legacy Products; Stage III-Continued Process Verification (CPV); Statistical Process Control and Control Charts; Notes; V: Other Related Activities.
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|a Electronic access restricted to authorized BRAC University faculty, staff and students
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| 538 |
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|a Mode of access: Internet
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| 650 |
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|a Pharmaceutical industry
|x Management.
|9 38021
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| 650 |
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|a Production engineering.
|9 38022
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| 650 |
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7 |
|a BUSINESS & ECONOMICS
|x Industries
|x General.
|2 bisacsh
|9 38023
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| 650 |
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7 |
|a Pharmaceutical industry
|x Management.
|2 fast
|9 38021
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| 650 |
|
7 |
|a Production engineering.
|2 fast
|9 38022
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| 655 |
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4 |
|a Electronic books.
|9 38025
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| 776 |
0 |
8 |
|i Print version:
|z 012804148X
|z 9780128041482
|w (OCoLC)938383710
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| 856 |
4 |
0 |
|z Full text available on ScienceDirect
|u https://www.sciencedirect.com/science/book/9780128041482
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| 942 |
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|2 ddc
|c EBK
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|w 2019-12-05
|y EBK
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