MARC details
| 000 -LEADER |
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| fixed length control field |
pam a22 i 4500 |
| 001 - CONTROL NUMBER |
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| control field |
AALScienceDirectebook000007 |
| 003 - CONTROL NUMBER IDENTIFIER |
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| control field |
BD-DhAAL |
| 005 - DATE AND TIME OF LATEST TRANSACTION |
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| control field |
20191205134318.0 |
| 006 - FIXED-LENGTH DATA ELEMENTS--ADDITIONAL MATERIAL CHARACTERISTICS--GENERAL INFORMATION |
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| fixed length control field |
m o d |
| 007 - PHYSICAL DESCRIPTION FIXED FIELD--GENERAL INFORMATION |
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| fixed length control field |
cr |n||||||||| |
| 008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION |
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| fixed length control field |
160614s2016 enk o 001 0 eng d |
| 015 ## - NATIONAL BIBLIOGRAPHY NUMBER |
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| National bibliography number |
GBB684816 |
| Source |
bnb |
| 016 7# - NATIONAL BIBLIOGRAPHIC AGENCY CONTROL NUMBER |
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| Record control number |
017889120 |
| Source |
Uk |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER |
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| International Standard Book Number |
0128096535 |
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| International Standard Book Number |
9780128096536 |
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| Cancelled/invalid ISBN |
012804148X |
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| Cancelled/invalid ISBN |
9780128041482 |
| 035 ## - SYSTEM CONTROL NUMBER |
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| System control number |
(OCoLC)951712418 |
| Canceled/invalid control number |
(OCoLC)951977754 |
| 040 ## - CATALOGING SOURCE |
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| Original cataloging agency |
BD-DhAAL |
| 050 #4 - LIBRARY OF CONGRESS CALL NUMBER |
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| Classification number |
HD9665.5 |
| 060 #4 - NATIONAL LIBRARY OF MEDICINE CALL NUMBER |
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| Classification number |
QV 778 |
| 072 #7 - SUBJECT CATEGORY CODE |
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| Subject category code |
BUS |
| Subject category code subdivision |
070000 |
| Source |
bisacsh |
| 082 04 - DEWEY DECIMAL CLASSIFICATION NUMBER |
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| Classification number |
338.476151 |
| Edition number |
23 |
| 100 1# - MAIN ENTRY--PERSONAL NAME |
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| Personal name |
Ostrove, Steve, |
| Relator term |
author. |
| 9 (RLIN) |
38020 |
| 245 10 - TITLE STATEMENT |
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| Title |
How to validate a pharmaceutical process / |
| Statement of responsibility, etc |
Steven A. Ostrove. |
| Medium |
[electronic resource] |
| 260 #1 - PUBLICATION, DISTRIBUTION, ETC. (IMPRINT) |
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| Place of publication, distribution, etc |
London, UK : |
| Name of publisher, distributor, etc |
Elsevier, |
| Date of publication, distribution, etc |
2016. |
| 300 ## - PHYSICAL DESCRIPTION |
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| Extent |
1 online resource |
| 500 ## - GENERAL NOTE |
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| General note |
<strong>Off-Campus Access:</strong> Athens ID and Password Required |
|
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| General note |
<strong>On-Campus Access:</strong> No User ID or Password Required |
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| General note |
Includes index. |
| 505 0# - FORMATTED CONTENTS NOTE |
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| 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. |
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| 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. |
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| 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. |
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| 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. |
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| 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. |
| 506 ## - RESTRICTIONS ON ACCESS NOTE |
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| Terms governing access |
Electronic access restricted to authorized BRAC University faculty, staff and students |
| 538 ## - SYSTEM DETAILS NOTE |
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| System details note |
Mode of access: Internet |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name as entry element |
Pharmaceutical industry |
| General subdivision |
Management. |
| 9 (RLIN) |
38021 |
|
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| Topical term or geographic name as entry element |
Production engineering. |
| 9 (RLIN) |
38022 |
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| Topical term or geographic name as entry element |
BUSINESS & ECONOMICS |
| General subdivision |
Industries |
| -- |
General. |
| Source of heading or term |
bisacsh |
| 9 (RLIN) |
38023 |
|
|---|
| Topical term or geographic name as entry element |
Pharmaceutical industry |
| General subdivision |
Management. |
| Source of heading or term |
fast |
| 9 (RLIN) |
38021 |
|
|---|
| Topical term or geographic name as entry element |
Production engineering. |
| Source of heading or term |
fast |
| 9 (RLIN) |
38022 |
| 655 #4 - INDEX TERM--GENRE/FORM |
|---|
| Genre/form data or focus term |
Electronic books. |
| -- |
38025 |
| 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 |
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| Public note |
Full text available on ScienceDirect |
| Uniform Resource Identifier |
<a href="https://www.sciencedirect.com/science/book/9780128041482">https://www.sciencedirect.com/science/book/9780128041482</a> |
| 942 ## - ADDED ENTRY ELEMENTS (KOHA) |
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| Source of classification or shelving scheme |
Dewey Decimal Classification |
| Item type |
E-Book |
