|
|
|
|
| LEADER |
00000cam a2200000 i 4500 |
| 001 |
SCIDIR_ocn951712418 |
| 003 |
OCoLC |
| 005 |
20231120112115.0 |
| 006 |
m o d |
| 007 |
cr |n||||||||| |
| 008 |
160614s2016 enk o 001 0 eng d |
| 040 |
|
|
|a YDXCP
|b eng
|e rda
|e pn
|c YDXCP
|d IDEBK
|d OPELS
|d OCLCO
|d EBLCP
|d OCLCO
|d OCLCF
|d OCLCO
|d N$T
|d OCLCO
|d IDB
|d MERUC
|d OCLCQ
|d RRP
|d U3W
|d WRM
|d D6H
|d OCLCA
|d OCLCQ
|d UWO
|d UKMGB
|d OCLCQ
|d S2H
|d OCLCO
|d LVT
|d VT2
|d OCLCO
|d OCLCQ
|d OCLCO
|
| 015 |
|
|
|a GBB684816
|2 bnb
|
| 016 |
7 |
|
|a 017889120
|2 Uk
|
| 019 |
|
|
|a 951977754
|a 1229630945
|a 1235834483
|
| 020 |
|
|
|a 9780128096536
|q (electronic bk.)
|
| 020 |
|
|
|a 0128096535
|q (electronic bk.)
|
| 020 |
|
|
|z 012804148X
|
| 020 |
|
|
|z 9780128041482
|
| 035 |
|
|
|a (OCoLC)951712418
|z (OCoLC)951977754
|z (OCoLC)1229630945
|z (OCoLC)1235834483
|
| 050 |
|
4 |
|a HD9665.5
|
| 060 |
|
4 |
|a QV 778
|
| 072 |
|
7 |
|a BUS
|x 070000
|2 bisacsh
|
| 082 |
0 |
4 |
|a 338.4/76151
|2 23
|
| 100 |
1 |
|
|a Ostrove, Steve,
|e author.
|
| 245 |
1 |
0 |
|a How to validate a pharmaceutical process /
|c Steven A. Ostrove.
|
| 264 |
|
1 |
|a London, UK :
|b Academic Press is an imprint of Elsevier,
|c 2016.
|
| 300 |
|
|
|a 1 online resource
|
| 336 |
|
|
|a text
|b txt
|2 rdacontent
|
| 337 |
|
|
|a computer
|b c
|2 rdamedia
|
| 338 |
|
|
|a online resource
|b cr
|2 rdacarrier
|
| 490 |
0 |
|
|a Expertise in pharmaceutical process technology series
|
| 500 |
|
|
|a Includes index.
|
| 588 |
0 |
|
|a Online resource; title from PDF title page (ScienceDirect, viewed June 21, 2016).
|
| 505 |
0 |
|
|a 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 |
|
|a 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 |
|
|a 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 |
|
|a 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 |
|
|a 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 |
|a Pharmaceutical industry
|x Management.
|
| 650 |
|
0 |
|a Production engineering.
|
| 650 |
|
6 |
|a Industrie pharmaceutique
|0 (CaQQLa)201-0042410
|x Gestion.
|0 (CaQQLa)201-0380063
|
| 650 |
|
6 |
|a Technique de la production.
|0 (CaQQLa)201-0030177
|
| 650 |
|
7 |
|a BUSINESS & ECONOMICS
|x Industries
|x General.
|2 bisacsh
|
| 650 |
|
7 |
|a Pharmaceutical industry
|x Management
|2 fast
|0 (OCoLC)fst01060159
|
| 650 |
|
7 |
|a Production engineering
|2 fast
|0 (OCoLC)fst01078282
|
| 776 |
0 |
8 |
|i Print version:
|z 012804148X
|z 9780128041482
|w (OCoLC)938383710
|
| 856 |
4 |
0 |
|u https://sciencedirect.uam.elogim.com/science/book/9780128041482
|z Texto completo
|
