UNITED BOOKS & PERIODICALS

LIST OF BOOKS ON DIFFERENT PHARMA SUBJECTS

VALIDATION
More titles will be added as and when are released.
Prices are subject to change withour prior notice. Please email us for checking the availability and pricing
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Handbook of Pharmaceutical Biotechnology

by Shayne Cox Gad (Editor)
June 2007, Hardcover
Validating Chromatographic Methods: A Practical Guide
by David M. Bliesner
September 2006, Hardcover
Analytical Method Validation and Instrument Performance Verification
by Chung Chow Chan (Editor), Y. C. Lee (Editor), Herman Lam (Editor), Xue-Ming Zhang
(Editor)
January 2004, Hardcover

Add to Cart

The Pharmaceutical Regulatory Process, Second Edition

Price: 145.00

ISBN:
Ira R. Berry; Robert P. Martin
9781420070439
(...more)
ISBN 10:
1420070436
CAT #: HE7043
Pub Date: 1/20/2009
Add to Cart

The Pharmaceutical Regulatory Process, Second Edition

Price: 145.00

ISBN:
Ira R. Berry; Robert P. Martin
9781420070422
(...more)
ISBN 10:
1420070428
CAT #: H7042
Pub Date: 1/20/2009 Series Name: Drugs and the Pharmaceutical Sciences
Add to Cart
ISBN:
9780849380372
ISBN 10:
0849380375
CAT #: 8037
Pub Date:
12/10/2007
Add to Cart
ISBN:
9780849370557
ISBN 10:
0849370558
CAT #: DK7055
Pub Date: 9/25/2007
Add to Cart
ISBN:
9780849382673
ISBN 10:
084938267X
CAT #: DK8267
Pub Date: 7/23/2007
Add to Cart
ISBN:
9781420055696
ISBN 10:
1420055690
CAT #: H5569
Pub Date: 6/26/2007
Add to Cart

ISBN:
9780849395291
ISBN 10:
0849395291
CAT #: 9529
Pub Date: 5/30/2006
Add to Cart
ISBN:
9781574448764
ISBN 10:
1574448765
CAT #: DK5758
Pub Date:
10/18/2005

Pharmaceutical Water: System Design Operation, and Validation, Second Edition

Price: 160.00

William V. Collentro
From chemical and biological purity requirements, to system design and its impact on water purity, to
the requirements and restrictions imposed by the regulators, this book covers the unique water req
(...more)

Validation of Pharmaceutical Processes, Third Edition

Price: 170.00

James P. Agalloco; Frederick J. Carleton

Completely revised and updated to reflect the significant advances in pharmaceutical production and
regulatory expectations, this third edition of Validation of Pharmaceutical Processes examines and b
(...more)

Validation and Qualification in Analytical Laboratories, Second Edition

Price: 130.00

Ludwig Huber
This Second Edition discusses ways to improve pharmaceutical product quality while achieving
compliance with global regulatory standards. With comprehensive step-by-step instructions, practical
recom (...more)

Pharmaceutical and Medical Device Validation by Experimental Design

Price: 115.00

Lynn D. Torbeck
This title demonstrates how designed experiments are the most scientific, efficient, and cost effective
method of data collection for validation in a laboratory setting. Intended as a learn-by-exampl
(...more)

Validation Standard Operating Procedures: A Step by Step Guide for Achieving

Compliance in the Pharmaceutical, Medical Device, and Biotech Industries, Second
Edition

Price: 160.00

Syed Imtiaz Haider

Spanning every critical element of validation for any pharmaceutical, diagnostic, medical device or
equipment, and biotech product, this Second Edition guides readers through each step in the correct
(...more)

Pharmaceutical Process Scale-Up, Second Edition

Price: 110.00

Michael Levin
Keeping pace with the increased influence of PAT in the pharmaceutical industry, this completely updated
reference spans the latest research and regulations, technologies, and expert solutions for eve
(...more)

Series Name: Drugs and the Pharmaceutical Sciences Volume: 157

Add to Cart
ISBN:
9780849323249
ISBN 10:
084932324X
CAT #: PH2324
Pub Date: 8/3/2005
Add to Cart
ISBN:
9781574445169
ISBN 10:
1574445162
CAT #: DK3346
Pub Date: 5/6/2005

Validating Pharmaceutical Systems: Good Computer Practice in Life Science

Manufacturing

Price: 145.00

John Andrews
All too often, the words "computer validation" strike terror into the hearts of those new to the process
and may even cause those familiar with it to tremble. Validating Pharmaceutical Systems: Good C
(...more)

Process Validation in Manufacturing of Biopharmaceuticals: Guidelines, Current

Practices, and Industrial Case Studies

Price: 115.00

Anurag S. Rathore; Gail Sofer

Written by experienced authorities in process validation, Process Validation in Manufacturing of
Biopharmaceuticals explores current trends in the field and strategies for the selection of the most ap
(...more)

Series Name: Biotechnology and Bioprocessing Volume: 29

Add to Cart
ISBN:
9780849321719
ISBN 10:
0849321719
CAT #: PH2171
Pub Date: 3/30/2005
Add to Cart

Write it Down: Guidance for Preparing Effective and Compliant Documentation,

Second Edition

Price: 130.00

Janet Gough
A well-understood tenet exists among the FDA and other regulatory bodies: if you didn't write it down, it
didn't happen. And if it didn't happen, your company stands to lose time, money, and perhaps i
(...more)

PHARMACEUTICALnetBASE: Pharmaceutical References Online

Price: 2,219.00

ISBN:
9780849329357
Whatever your needs are for reliable pharmaceutical information, you can find it here.
ISBN 10:
PHARMACEUTICALnetBASE is a soup-to-nuts online library of CRC's many respected resources in drug
0849329353
discovery and de (...more)
CAT #: WB035
Pub Date: 12/3/2004
Add to Cart
ISBN:
9780849323409
ISBN 10:
0849323401
CAT #: PH2340
Pub Date: 3/29/2004
Add to Cart
ISBN:
9780849322433
ISBN 10:
084932243X
CAT #: PH2243
Pub Date: 1/15/2004
Add to Cart
ISBN:
9780849321641
ISBN 10:
0849321646
CAT #: PH2164
Pub Date:
12/29/2003
Add to Cart
ISBN:
9780849318719
ISBN 10:
0849318718
CAT #: PH1871

Facility Validation: Theory, Practice, and Tools

Price: 95.00

Graham C. Wrigley
Often considered a necessary evil by the pharmaceutical industry, validation is still understood by many
as unrestrained bureaucracy, paperwork, and procedures whose roots and logic are obscure and on
(...more)

21 CFR Part 11: Complete Guide to International Computer Validation Compliance for
the Pharmaceutical Industry

Price: 115.00

Orlando Lopez
In the FDA regulated environment, it is not acceptable for programmers or their managers to deviate
from standardized methodologies. Given the type of software commonly found in FDA regulated
operatio (...more)

Electronic Record Keeping: Achieving and Maintaining Compliance with 21 CFR Part 11
and 45 CFR Parts 160, 162, and 164

Price: 145.00

David Nettleton; Janet Gough

The current revolution in software, and the regulations that have evolved to address it, have increasingly
caused companies to turn to off-the-shelf software for electronic record keeping. Data captur (...more)

Computer Systems Validation: Quality Assurance, Risk Management, and Regulatory

Compliance for Pharmaceutical and Healthcare Companies

Price: 285.00

Guy Wingate
Both pervasive and ubiquitous, computerized systems are now an integral component of every corporate
strategy in pharmaceutical and healthcare companies. However, when technology is combined with
high (...more)

Pub Date:
12/18/2003
Add to Cart
ISBN:
9780849321870
ISBN 10:
0849321875
CAT #: PH2187
Pub Date:
11/17/2003
Add to Cart
ISBN:
9781566768078
ISBN 10:
1566768071
CAT #: TX68071
Pub Date: 9/27/2002
Add to Cart
ISBN:
9781574911190
ISBN 10:
1574911198
CAT #: PH1198
Pub Date:
12/31/2001
Add to Cart
ISBN:
9781574443301
ISBN 10:
1574443305
CAT #: SL3305
Pub Date:
12/27/2001
Add to Cart
ISBN:
9781574911336
ISBN 10:
1574911333
CAT #: PH1333
Pub Date: 10/1/2001
Add to Cart
ISBN:
9781574911176
ISBN 10:
1574911171
CAT #: PH1171
Pub Date: 5/31/2000
Add to Cart
ISBN:
9781574911169
ISBN 10:
1574911163
CAT #: PH1663
Pub Date: 2/28/2000
Add to Cart
ISBN:
9781574911084
ISBN 10:

Compact Regs Part 26: CFR 21 Part 26 Mutual Recognition: US and the European
Community (10 Pack)

Price: 55.00

(...more)

Validating Medical Packaging

Price: 99.00

Ronald Pilchik
According to the FDA Quality System Regulations, manufacturers must ensure that "device packaging
and shipping containers are designed and constructed to protect the device from alteration or damage
d (...more)

Validation of Active Pharmaceutical Ingredients, Second Edition

Price: 170.00

Ira R. Berry; Daniel Harpaz

Much has happened in the area of bulk pharmaceutical good manufacturing practice (GMP) and
validation since the first publication of Validation of Active Pharmaceutical Ingredients. Revised, updated,
(...more)

Pharmaceutical Master Validation Plan: The Ultimate Guide to FDA, GMP, and GLP
Compliance

Price: 110.00

Syed Imtiaz Haider

The Master Validation Plan provides a roadmap to management for on-time start-up of facility
operations, and validation of existing facilities, in compliance with GMP requirements. The lack of a
compr (...more)

Validation of Computerized Analytical and Networked Systems

Price: 171.00

Ludwig Huber
You cannot afford to be in the dark when it comes to validating your analytical systems and lab software.
Written by international laboratory and compliance expert Dr. Ludwig Huber, Validation of Comp
(...more)

Validating Corporate Computer Systems: Good IT Practice for Pharmaceutical

Manufacturers

Price: 160.00

Guy Wingate
One of the biggest computer validation challenges facing pharmaceutical manufacturers is the large
corporate system. This book provides practical information and advice on good IT practice and validat
(...more)

Validated Cleaning Technologies for Pharmaceutical Manufacturing

Price: 130.00

Destin A. LeBlanc
Written by an expert for those who must design validatable cleaning processes and then validate those
processes, this book discusses interdependent topics from various technical areas and disciplines.
(...more)

Cleaning Validation: A Practical Approach

Price: 130.00

Gil Bismuth; Shosh Neumann

Offering a detailed, step-by-step guide to building a compliant cleaning validation program, Cleaning
Validation: A Practical Approach covers trends in control, procedures, cleaning agents and tools,

1574911082
(...more)
CAT #: PH1082
Pub Date: 1/31/2000
Add to Cart
ISBN:
9781574910971
ISBN 10:
1574910973
CAT #: PH0973
Pub Date: 9/30/1999

Add to Cart
ISBN:
9781574910988
ISBN 10:
1574910981
CAT #: PH0981
Pub Date: 8/31/1999
Add to Cart
ISBN:
9781574910896
ISBN 10:
1574910892
CAT #: PH0892
Pub Date:
10/31/1998
Add to Cart
ISBN:
9781574910278
ISBN 10:
1574910272
CAT #: PH0272
Pub Date: 9/30/1998
Add to Cart
ISBN:
9781574910797
ISBN 10:
1574910795
CAT #: PH0795
Pub Date: 8/31/1998
Add to Cart
ISBN:
9781574910681
ISBN 10:
157491068X
CAT #: PH068X
Pub Date: 6/30/1998
Add to Cart
ISBN:
9780824701192
ISBN 10:
0824701194
CAT #: DK1437
Pub Date: 6/16/1998
Add to Cart
ISBN:
9781574910674
ISBN 10:
1574910671

How to Sell Validatable Equipment to Pharmaceutical Manufacturers

Price: 160.00

Erik Kopp
Suppliers of pharmaceutical manufacturing equipment must ensure that their equipment is provided to
their customers in a validatable state. Written in simple, clear, and concise language that gets pas
(...more)

How to Develop and Manage Qualification Protocols for FDA Compliance

Price: 170.00

Phil Cloud
All current Good Manufacturing Practices (cGMP), Good Clinical Practices (GCP), Good Laboratory
Practices (GLP) and ISO 9000 standards and regulations require that validation document be established
a (...more)

Biotechnology: Quality Assurance and Validation

Price: 130.00

Kenneth E. Avis; Carmen M. Wagner; Vincent L. Wu

Biotechnology: Quality Assurance and Validation provides a practical, detailed discussion of what issues
Quality Assurance and Quality Control need to identify for effective control in the preparation (...more)

Pharmaceutical Water: System Design, Operation, and Validation

Price: 160.00

William V. Collentro
From chemical and biological purity requirements, to system design and its impact on water purity, to
the requirements and restrictions imposed by the regulators, this book comprehensively covers the
(...more)

Pharmaceutical Equipment Validation: The Ultimate Qualification Guidebook

Price: 160.00

Phil Cloud
While FDA regulations, cGMP, GLP, GCP, and the industry standard ISO 9000 require that documentation
be established and followed, they do not provide guidelines on how to produce that documentation. P
(...more)

Data Acquisition and Measurement Techniques

Price: 160.00

Angel Munoz-Ruiz; Herman Vromans

Data Acquisition and Measurement Techniques offers the practical help needed to understand and
implement new technology and perform the constant discipline crossover necessary to achieve high
quality (...more)

Automation and Validation of Information in Pharmaceutical Processing

Price: 115.00

This thoroughly authoritative work furnishes organizational, technological, validation, project

management, and business perspectives on pharmaceutical information automation from industry and
system (...more)
Series Name: Drugs and the Pharmaceutical Sciences Volume: 90
The Survive and Thrive Guide to Computer Validation

Price: 160.00

Teri Stokes
Computer validation regulations have increased worldwide by 300 percent since 1991. Drawing on her
practical project experience in pharmaceutical, biotech, and software companies around the world, aut
(...more)

CAT #: PH0671
Pub Date: 5/31/1998
Add to Cart
ISBN:
9781574910704
ISBN 10:
1574910701
CAT #: PH0701
Pub Date: 4/30/1998
Add to Cart
ISBN:
9781574910629
ISBN 10:
1574910620
CAT #: PH0620
Pub Date:
10/31/1997
Add to Cart
ISBN:
9781574910636
ISBN 10:
1574910639
CAT #: PH0639
Pub Date: 9/30/1997
Add to Cart
ISBN:
9781574910377
ISBN 10:
157491037X
CAT #: PH037X
Pub Date: 6/30/1997
Add to Cart

Validation Fundamentals: How To, What To, When To Validate

Price: 115.00

William Gibson; Keith Powell-Evans

Written by the founders of the Institute of Validation, this practical introduction to validation cuts
through all the jargon and focuses on the essentials. Whether you are a novice or an experienced
(...more)

Microbial Limit and Bioburden Tests: Validation Approaches and Global Requirements

Price: 130.00

Lucia Clontz
This invaluable book guides readers through the microbial limit testing methodologies of the major world
markets, including the US Pharmacopeia, the European Pharmacopoeia, British Pharmacopoeia, and
(...more)

Validation for Medical Device and Diagnostic Manufacturers, Second Edition

Price: 130.00

Carol V. Desain; Charmaine V. Sutton

Implementation of FDA's Design Control requirements (21 CFR 820.30) changed an entire industry.
Quality System Requirements defined the approach to medical device validation. Product design,
manufactu (...more)

Validating Automated Manufacturing and Laboratory Applications: Putting Principles

into Practice

Price: 170.00

Guy Wingate
Since 1994, the German GMA-NAMUR, German APV, ISPE-Baseline, OECD, UK GAMP Forum, UK IQAPQG, US DIA, ISPE, and PDA initiatives have supplemented the regulations governing the validation of
automated (...more)

Cleaning and Cleaning Validation: A Biotechnology Perspective

Price: 170.00

ISBN:
Jon Voss
9780939459506
(...more)
ISBN 10:
0939459507
CAT #: PH9507
Pub Date: 6/30/1996
Add to Cart
ISBN:
9780935184822
ISBN 10:
0935184821
CAT #: PH4821
Pub Date: 1/31/1996
Add to Cart
ISBN:
9780935184754
ISBN 10:
0935184759
CAT #: PH4759
Pub Date: 5/31/1995
Add to Cart
ISBN:
9780824793364
ISBN 10:
0824793366
CAT #: DK5104

Automated Microbial Identification and Quantitation: Technologies for the 2000s

Price: 130.00

Wayne P. Olson
This book focuses on practical, proven applications to automate the microbial identification process
economically and with greater levels of safety and quality for patients. A diverse group of recogni
(...more)

Validation of Computerized Analytical Systems

Price: 114.00

Ludwig Huber
Validation of Computerized Analytical and Networked Systems provides the definitive rationales, logic,
and methodology for validation of computerized analytical systems. Whether you are involved with
(...more)

Statistical Design and Analysis in Pharmaceutical Science: Validation, Process

Controls, and Stability

Price: 39.99

Shein-Chung Chow; Jen-pei Liu

"Offers a comprehensive, unified presentation of statistical designs and methods of analysis for all
stages of pharmaceutical development--emphasizing biopharmaceutical applications and demonstrating
(...more)

Pub Date: 2/22/1995

Series Name: Statistics: A Series of Textbooks and Monographs Volume: 143
Add to Cart

Good Computer Validation Practices: Common Sense Implementation

Price: 165.00

ISBN:
Teri Stokes; Ronald C. Branning; Kenneth G. Chapman; Heinrich Hambloch; Anthony J. Trill
9780935184556
This sensible text on computer systems validation examines the regulatory and practical issues of
ISBN 10:
computer validation from a global perspective and provides a common-sense approach to getting the job
0935184554
(...more)
CAT #: PH4554
Pub Date: 5/31/1994
Add to Cart
ISBN:
9780935184488
ISBN 10:
0935184481
CAT #: PH4481
Pub Date: 1/31/1994

Computer Validation Compliance: A Quality Assurance Perspective

Price: 114.00

Mary Ellen Double; Maryann McKendry

Computer Validation Compliance takes a systematic Quality Assurance (QA) approach to computer
validation in a regulated environment. Built on the authors' experiences at major multinational
pharmaceut (...more)