How to validate a pharmaceutical process / (Record no. 247350)
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| fixed length control field | 04598cam a2200505Ii 4500 |
| 001 - CONTROL NUMBER | |
| control field | ocn951712418 |
| 003 - CONTROL NUMBER IDENTIFIER | |
| control field | OCoLC |
| 005 - DATE AND TIME OF LATEST TRANSACTION | |
| control field | 20190328114815.0 |
| 006 - FIXED-LENGTH DATA ELEMENTS--ADDITIONAL MATERIAL CHARACTERISTICS | |
| fixed length control field | m o d |
| 007 - PHYSICAL DESCRIPTION FIXED FIELD--GENERAL INFORMATION | |
| fixed length control field | cr |n||||||||| |
| 008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION | |
| fixed length control field | 160614s2016 enk o 001 0 eng d |
| 040 ## - CATALOGING SOURCE | |
| Original cataloging agency | YDXCP |
| Language of cataloging | eng |
| Description conventions | rda |
| -- | pn |
| Transcribing agency | YDXCP |
| Modifying agency | IDEBK |
| -- | OPELS |
| -- | OCLCO |
| -- | EBLCP |
| -- | OCLCO |
| -- | OCLCF |
| -- | OCLCO |
| -- | N$T |
| -- | OCLCO |
| -- | IDB |
| -- | MERUC |
| -- | OCLCQ |
| -- | RRP |
| -- | U3W |
| -- | WRM |
| -- | D6H |
| -- | OCLCA |
| -- | OCLCQ |
| -- | UWO |
| 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 | |
| Canceled/invalid ISBN | 012804148X |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER | |
| Canceled/invalid ISBN | 9780128041482 |
| 035 ## - SYSTEM CONTROL NUMBER | |
| System control number | (OCoLC)951712418 |
| Canceled/invalid control number | (OCoLC)951977754 |
| 050 #4 - LIBRARY OF CONGRESS CALL NUMBER | |
| Classification number | HD9665.5 |
| 060 #4 - NATIONAL LIBRARY OF MEDICINE CALL NUMBER | |
| Classification number | QV 778 |
| 072 #7 - SUBJECT CATEGORY CODE | |
| Subject category code | BUS |
| Subject category code subdivision | 070000 |
| Source | bisacsh |
| 082 04 - DEWEY DECIMAL CLASSIFICATION NUMBER | |
| Classification number | 338.4/76151 |
| Edition number | 23 |
| 100 1# - MAIN ENTRY--PERSONAL NAME | |
| Personal name | Ostrove, Steve, |
| Relator term | author. |
| 245 10 - TITLE STATEMENT | |
| Title | How to validate a pharmaceutical process / |
| Medium | [electronic resource] |
| Statement of responsibility, etc. | Steven A. Ostrove. |
| 264 #1 - PRODUCTION, PUBLICATION, DISTRIBUTION, MANUFACTURE, AND COPYRIGHT NOTICE | |
| 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, or copyright notice | 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# - SOURCE OF DESCRIPTION NOTE | |
| Source of description note | 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. |
| 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 |
| Authority record control number | (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 |
| Authority record control number | (OCoLC)fst01078282 |
| 655 #4 - INDEX TERM--GENRE/FORM | |
| Genre/form data or focus term | Electronic books. |
| 776 08 - ADDITIONAL PHYSICAL FORM ENTRY | |
| Relationship information | Print version: |
| International Standard Book Number | 012804148X |
| -- | 9780128041482 |
| Record control number | (OCoLC)938383710 |
| 856 40 - ELECTRONIC LOCATION AND ACCESS | |
| Materials specified | ScienceDirect |
| Uniform Resource Identifier | http://www.sciencedirect.com/science/book/9780128041482 |
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