How to validate a pharmaceutical process / (Record no. 540942)
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| 000 -LEADER | |
|---|---|
| fixed length control field | 04454cam a2200493Ii 4500 |
| 001 - CONTROL NUMBER | |
| control field | ocn951712418 |
| 003 - CONTROL NUMBER IDENTIFIER | |
| control field | OCoLC |
| 005 - DATE AND TIME OF LATEST TRANSACTION | |
| control field | 20180529115917.0 |
| 008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION | |
| fixed length control field | 160614s2016 enk o 001 0 eng d |
| 019 ## - | |
| -- | 951977754 |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER | |
| International Standard Book Number | 9780128096536 |
| Qualifying information | (electronic bk.) |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER | |
| International Standard Book Number | 0128096535 |
| Qualifying information | (electronic bk.) |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER | |
| Cancelled/invalid ISBN | 012804148X |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER | |
| Cancelled/invalid ISBN | 9780128041482 |
| 035 ## - SYSTEM CONTROL NUMBER | |
| System control number | (OCoLC)951712418 |
| 040 ## - CATALOGING SOURCE | |
| Original cataloging agency | DLC |
| Language of cataloging | eng |
| Transcribing agency | DLC |
| Modifying agency | AU |
| 049 ## - LOCAL HOLDINGS (OCLC) | |
| Holding library | Alfaisal Main Library |
| 050 #4 - LIBRARY OF CONGRESS CALL NUMBER | |
| Classification number | HD9665.5 |
| 100 1# - MAIN ENTRY--PERSONAL NAME | |
| Personal name | Ostrove, Steve, |
| Relator term | author. |
| 245 10 - TITLE STATEMENT | |
| Title | How to validate a pharmaceutical process / |
| Statement of responsibility, etc | Steven A. Ostrove. |
| 264 #1 - PRODUCTION, PUBLICATION, DISTRIBUTION, MANUFACTURE STATEMENTS | |
| Place of production, publication, distribution, manufacture | London, UK : |
| Name of producer, publisher, distributor, manufacturer | Academic Press is an imprint of Elsevier, |
| Date of production, publication, distribution, manufacture | 2016. |
| 260 ## - PUBLICATION, DISTRIBUTION, ETC. (IMPRINT) | |
| Date of publication, distribution, etc | 2016. |
| 300 ## - PHYSICAL DESCRIPTION | |
| Extent | 1 online resource |
| 336 ## - CONTENT TYPE | |
| Content Type Term | text |
| Content Type Code | txt |
| Source | rdacontent |
| 337 ## - MEDIA TYPE | |
| Media Type Term | computer |
| Media Type Code | c |
| Source | rdamedia |
| 338 ## - CARRIER TYPE | |
| Carrier Type Term | online resource |
| Carrier Type Code | cr |
| Source | rdacarrier |
| 500 ## - GENERAL NOTE | |
| General note | Includes index. |
| 588 0# - | |
| -- | Online resource; title from PDF title page (ScienceDirect, viewed June 21, 2016). |
| 505 0# - FORMATTED CONTENTS NOTE | |
| Formatted contents note | 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. |
| 505 8# - FORMATTED CONTENTS NOTE | |
| Formatted contents note | 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. |
| 505 8# - FORMATTED CONTENTS NOTE | |
| Formatted contents note | 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. |
| 505 8# - FORMATTED CONTENTS NOTE | |
| Formatted contents note | 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. |
| 505 8# - FORMATTED CONTENTS NOTE | |
| Formatted contents note | 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. |
| 590 ## - LOCAL NOTE (RLIN) | |
| Local note | Elsevier |
| Provenance (VM) [OBSOLETE] | ScienceDirect All Books |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | Pharmaceutical industry |
| General subdivision | Management. |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | Production engineering. |
| 650 #7 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | BUSINESS & ECONOMICS |
| General subdivision | Industries |
| -- | General. |
| Source of heading or term | bisacsh |
| 650 #7 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | Pharmaceutical industry |
| General subdivision | Management. |
| Source of heading or term | fast |
| -- | (OCoLC)fst01060159 |
| 650 #7 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | Production engineering. |
| Source of heading or term | fast |
| -- | (OCoLC)fst01078282 |
| 655 #7 - INDEX TERM--GENRE/FORM | |
| Genre/form data or focus term | Electronic books. |
| Source of term | local |
| 710 2# - ADDED ENTRY--CORPORATE NAME | |
| Corporate name or jurisdiction name as entry element | ScienceDirect eBooks. |
| 776 08 - ADDITIONAL PHYSICAL FORM ENTRY | |
| Display text | Print version: |
| International Standard Book Number | 012804148X |
| -- | 9780128041482 |
| Record control number | (OCoLC)938383710 |
| 856 40 - ELECTRONIC LOCATION AND ACCESS | |
| Uniform Resource Identifier | <a href="http://ezproxy.alfaisal.edu/login?url=https://www.sciencedirect.com/science/book/9780128041482">http://ezproxy.alfaisal.edu/login?url=https://www.sciencedirect.com/science/book/9780128041482</a> |
| 942 ## - ADDED ENTRY ELEMENTS (KOHA) | |
| Source of classification or shelving scheme | Library of Congress Classification |
| Koha item type | eBooks |
No items available.