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_c41952 _d41952 |
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| 001 | AALScienceDirectebook000007 | ||
| 003 | BD-DhAAL | ||
| 005 | 20191205134318.0 | ||
| 006 | m o d | ||
| 007 | cr |n||||||||| | ||
| 008 | 160614s2016 enk o 001 0 eng d | ||
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_aGBB684816 _2bnb |
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| 016 | 7 |
_a017889120 _2Uk |
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| 020 | _a0128096535 | ||
| 020 | _a9780128096536 | ||
| 020 | _z012804148X | ||
| 020 | _z9780128041482 | ||
| 035 |
_a(OCoLC)951712418 _z(OCoLC)951977754 |
||
| 040 | _aBD-DhAAL | ||
| 050 | 4 | _aHD9665.5 | |
| 060 | 4 | _aQV 778 | |
| 072 | 7 |
_aBUS _x070000 _2bisacsh |
|
| 082 | 0 | 4 |
_a338.476151 _223 |
| 100 | 1 |
_aOstrove, Steve, _eauthor. _938020 |
|
| 245 | 1 | 0 |
_aHow to validate a pharmaceutical process / _cSteven A. Ostrove. _h[electronic resource] |
| 260 | 1 |
_aLondon, UK : _bElsevier, _c2016. |
|
| 300 | _a1 online resource | ||
| 500 | _a<strong>Off-Campus Access:</strong> Athens ID and Password Required | ||
| 500 | _a<strong>On-Campus Access:</strong> No User ID or Password Required | ||
| 500 | _aIncludes index. | ||
| 505 | 0 | _aFront 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. | |
| 505 | 8 | _a11 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. | |
| 505 | 8 | _aII: 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. | |
| 505 | 8 | _aLaboratory 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. | |
| 505 | 8 | _aRisk 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. | |
| 506 | _aElectronic access restricted to authorized BRAC University faculty, staff and students | ||
| 538 | _aMode of access: Internet | ||
| 650 | 0 |
_aPharmaceutical industry _xManagement. _938021 |
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| 650 | 0 |
_aProduction engineering. _938022 |
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| 650 | 7 |
_aBUSINESS & ECONOMICS _xIndustries _xGeneral. _2bisacsh _938023 |
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| 650 | 7 |
_aPharmaceutical industry _xManagement. _2fast _938021 |
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| 650 | 7 |
_aProduction engineering. _2fast _938022 |
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| 655 | 4 |
_aElectronic books. _938025 |
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| 776 | 0 | 8 |
_iPrint version: _z012804148X _z9780128041482 _w(OCoLC)938383710 |
| 856 | 4 | 0 |
_zFull text available on ScienceDirect _uhttps://www.sciencedirect.com/science/book/9780128041482 |
| 942 |
_2ddc _cEBK |
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