MARC details
000 -LEADER |
fixed length control field |
pam a22 i 4500 |
001 - CONTROL NUMBER |
control field |
AALScienceDirectebook000007 |
003 - CONTROL NUMBER IDENTIFIER |
control field |
BD-DhAAL |
005 - DATE AND TIME OF LATEST TRANSACTION |
control field |
20191205134318.0 |
006 - FIXED-LENGTH DATA ELEMENTS--ADDITIONAL MATERIAL CHARACTERISTICS--GENERAL INFORMATION |
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 |
015 ## - NATIONAL BIBLIOGRAPHY NUMBER |
National bibliography number |
GBB684816 |
Source |
bnb |
016 7# - NATIONAL BIBLIOGRAPHIC AGENCY CONTROL NUMBER |
Record control number |
017889120 |
Source |
Uk |
020 ## - INTERNATIONAL STANDARD BOOK NUMBER |
International Standard Book Number |
0128096535 |
|
International Standard Book Number |
9780128096536 |
|
Cancelled/invalid ISBN |
012804148X |
|
Cancelled/invalid ISBN |
9780128041482 |
035 ## - SYSTEM CONTROL NUMBER |
System control number |
(OCoLC)951712418 |
Canceled/invalid control number |
(OCoLC)951977754 |
040 ## - CATALOGING SOURCE |
Original cataloging agency |
BD-DhAAL |
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 |
338.476151 |
Edition number |
23 |
100 1# - MAIN ENTRY--PERSONAL NAME |
Personal name |
Ostrove, Steve, |
Relator term |
author. |
9 (RLIN) |
38020 |
245 10 - TITLE STATEMENT |
Title |
How to validate a pharmaceutical process / |
Statement of responsibility, etc |
Steven A. Ostrove. |
Medium |
[electronic resource] |
260 #1 - PUBLICATION, DISTRIBUTION, ETC. (IMPRINT) |
Place of publication, distribution, etc |
London, UK : |
Name of publisher, distributor, etc |
Elsevier, |
Date of publication, distribution, etc |
2016. |
300 ## - PHYSICAL DESCRIPTION |
Extent |
1 online resource |
500 ## - GENERAL NOTE |
General note |
<strong>Off-Campus Access:</strong> Athens ID and Password Required |
|
General note |
<strong>On-Campus Access:</strong> No User ID or Password Required |
|
General note |
Includes index. |
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. |
|
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. |
|
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. |
|
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. |
|
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 |
Terms governing access |
Electronic access restricted to authorized BRAC University faculty, staff and students |
538 ## - SYSTEM DETAILS NOTE |
System details note |
Mode of access: Internet |
650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name as entry element |
Pharmaceutical industry |
General subdivision |
Management. |
9 (RLIN) |
38021 |
|
Topical term or geographic name as entry element |
Production engineering. |
9 (RLIN) |
38022 |
|
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 |
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) |
Source of classification or shelving scheme |
Dewey Decimal Classification |
Item type |
E-Book |