How to validate a pharmaceutical process /
Ostrove, Steve,
How to validate a pharmaceutical process / [electronic resource] Steven A. Ostrove. - London, UK : Elsevier, 2016. - 1 online resource
Off-Campus Access: Athens ID and Password Required On-Campus Access: 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
0128096535 9780128096536
GBB684816 bnb
017889120 Uk
017889120 Uk
017889120 Uk
017889120 Uk
017889120 Uk
017889120 Uk
017889120 Uk
017889120 Uk
HD9665.5
338.476151
QV 778
How to validate a pharmaceutical process / [electronic resource] Steven A. Ostrove. - London, UK : Elsevier, 2016. - 1 online resource
Off-Campus Access: Athens ID and Password Required On-Campus Access: 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
0128096535 9780128096536
GBB684816 bnb
017889120 Uk
017889120 Uk
017889120 Uk
017889120 Uk
017889120 Uk
017889120 Uk
017889120 Uk
017889120 Uk
HD9665.5
338.476151
QV 778