000			04598cam a2200505Ii 4500
001			ocn951712418
003			OCoLC
005			20190328114815.0
006			m o d
007			cr |n|||||||||
008			160614s2016 enk o 001 0 eng d
040			_aYDXCP _beng _erda _epn _cYDXCP _dIDEBK _dOPELS _dOCLCO _dEBLCP _dOCLCO _dOCLCF _dOCLCO _dN$T _dOCLCO _dIDB _dMERUC _dOCLCQ _dRRP _dU3W _dWRM _dD6H _dOCLCA _dOCLCQ _dUWO
019			_a951977754
020			_a9780128096536 _q(electronic bk.)
020			_a0128096535 _q(electronic bk.)
020			_z012804148X
020			_z9780128041482
035			_a(OCoLC)951712418 _z(OCoLC)951977754
050		4	_aHD9665.5
060		4	_aQV 778
072		7	_aBUS _x070000 _2bisacsh
082	0	4	_a338.4/76151 _223
100	1		_aOstrove, Steve, _eauthor.
245	1	0	_aHow to validate a pharmaceutical process / _h[electronic resource] _cSteven A. Ostrove.
264		1	_aLondon, UK : _bAcademic Press is an imprint of Elsevier, _c2016.
300			_a1 online resource
336			_atext _btxt _2rdacontent
337			_acomputer _bc _2rdamedia
338			_aonline resource _bcr _2rdacarrier
500			_aIncludes index.
588	0		_aOnline resource; title from PDF title page (ScienceDirect, viewed June 21, 2016).
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		_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.
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.
650		0	_aPharmaceutical industry _xManagement.
650		0	_aProduction engineering.
650		7	_aBUSINESS & ECONOMICS _xIndustries _xGeneral. _2bisacsh
650		7	_aPharmaceutical industry _xManagement. _2fast _0(OCoLC)fst01060159
650		7	_aProduction engineering. _2fast _0(OCoLC)fst01078282
655		4	_aElectronic books.
776	0	8	_iPrint version: _z012804148X _z9780128041482 _w(OCoLC)938383710
856	4	0	_3ScienceDirect _uhttp://www.sciencedirect.com/science/book/9780128041482
999			_c247350 _d247350