04729pam a2200541 i 4500 AALScienceDirectebook000007 BD-DhAAL 20191205134318.0 m o d cr |n||||||||| 160614s2016 enk o 001 0 eng d 41952 41952 GBB684816 bnb 017889120 Uk 0128096535 9780128096536 012804148X 9780128041482 (OCoLC)951712418 (OCoLC)951977754 BD-DhAAL HD9665.5 QV 778 BUS 070000 bisacsh 338.476151 23 Ostrove, Steve, author. 38020 How to validate a pharmaceutical process / Steven A. Ostrove. [electronic resource] London, UK : Elsevier, 2016. 1 online resource <strong>Off-Campus Access:</strong> Athens ID and Password Required <strong>On-Campus Access:</strong> No User ID or Password Required Includes index. 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. 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. 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. 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. 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. Electronic access restricted to authorized BRAC University faculty, staff and students Mode of access: Internet Pharmaceutical industry Management. 38021 Production engineering. 38022 BUSINESS & ECONOMICS Industries General. bisacsh 38023 Pharmaceutical industry Management. fast 38021 Production engineering. fast 38022 Electronic books. 38025 Print version: 012804148X 9780128041482 (OCoLC)938383710 Full text available on ScienceDirect https://www.sciencedirect.com/science/book/9780128041482 ddc EBK 0 0 ddc 0 338_476151000000000_OST 0 67375 BRACUL BRACUL 2019-12-05 0 338.476151 OST 2019-12-05 2019-12-05 EBK