| Book |
About The Book |
Price |
 |
Pharmaceutical Process Validation
An International Third Edition,Revised
and Expanded
Edited by :
Robert A. Nash
Steven Institute of Technology , Hoboken ,New Jersey ,USA
Alfred H. Wachter
Wachter Pharma Projects , Therwil ,Switzerland
Mrcel Dekker, 2003
Offers guidence and expertise from a diverse range of international
authorities.
920 pp., illus. / ISBN:0-8247-0838-5
Table of Contents
Regulatory Basis for Process Validation : John M. Dietrick and Bernard
T. Loftus
Prospective Process Validation
: Allen Y. Chao, F. St. Forbes, and Reginald F. Johnson Retrospective
Process Validation : Chester J. Trubinski
Sterilization
Validation Michael J. Akers and Neil R. Anderson
Validation
of Solid Dosage Forms Jeffrey S. Rudolph and Robert J. Sepeljak
Validation of Medical Devices Toshiaki Nishihata
Validation of Biotechnology Processes Gail Sofer
Transdermal Process Validation Charlie Neal, Jr.
Validation of Lyophilized Products Edward H. Trappler
Validation of Inhalation of Aerosols Chris Sciarra and
John Sciarra
Process Validation of Pharmaceutical
Ingredients Robert A. Nash
Qualification of Water and Air Handling Systems Kunio Kawamura
Equipment and Facility Qualification Tom
Peither
Validation and Verification of Cleaning
Processes William E. Hall
Analytical Methods
Validation Ludwig Huber
Computer Systems
Validation Tony de Claire
Integrated Packaging
Validation Mervyn J. Frederick
Analysis
of Process Data Using Quality Control Charts Peter Cheng and John Dutt
Statistical Methods for Blend Uniformity and Dissolution Testing Bergum
and Utter Change Control and SUPAC Nellie H. Waterland and Christopher
C. Kowtna
Process Validation and Quality
Assurance Carl B. Rifino
Validation in Contract Manufacturing Dilip M. Parikh
Terminology on Non-Aseptic Process Validation Kenneth G.
Chapman
Harmonization, GMPs, and Validation
Alfred Wachter
|
US$ 235.00
Non-Member
US$ 211.50
progamma Club member
|
 |
Validation
of Pharmaceutical Processes
Sterile Products
Second Eidition, Revised and Expanded
edited by
Frederick J. Carleton
Carleton Technologies , Inc. Boynton Beach , Florida,USA
James P. Agalloco
Agalloco and Associates, Belle Mead, New Jersey Book
| Print Published: 11/05/1998 Hard Cover 856 pages | Illustrated 5th
Printing Print ISBN: 0-8247-9384-6
This book
provides a completely updated, single-source reference detailing the
design of systems, qualification of equipment, calibration and certification,
and explicit procedures for the validation of systems required in the
preparation of aseptic and nonaseptic pharmaceutical products. Featuring
contributions from 25 specialists, Validation of Pharmaceutical Processes:
Sterile Products, Second Edition |
US$ 195.00
Non-Member
US$ 175.50
progamma Club member
|
 |
Good Laboratory Practice Regulations
Third Edition, Revised and Expanded
Edited by: S. Weinberg
Muhlenberg College, Allentown, Pennsylvania
Print Published: 11/06/2002 | Online Published: 11/06/2002 Hard Cover
264 pages | Illustrated Print ISBN: 0-8247-0891-1
Reviews
"…the present volume…should
be on the shelf of…every individual having responsibility in a
Quality Control function." —Journal of Pharmaceutical and Biomedical
Analysis |
US$ 135.00
Non-Member
US$ 122.00
progamma Club member
|
 |
Pharmaceutical Project Management
Edited by: Tony Kennedy
Roche Products Ltd., Welwyn Garden City, England Book | Print Published:
10/24/1997 Hard Cover 304 pages | Illustrated 7th Printing Print
ISBN: 0-8247-0111-9
Draws on
the invaluable experience of project management experts from international
pharmaceutical companies and consultancies. Reviews the latest strategic,
operational, and organizational procedures essential for successful
drug development in today's competitive industry. Details how "target
product profiles" are established and used to direct drug development;
covers project definition and risk management, including analytical
techniques and asset valuation at the project and portfolio levels;
and more.
|
US$ 135.00
Non-Member
US$ 122.00
progamma Club member
|
 |
Good
Manufacturing Practices for Pharmaceuticals
A Plan for Total Quality Control from
Manufacturer to Consumer, Fifth Edition, Revised and Expanded
by : Sidney H. Willig
Professor Emeritus, Law & the Health Sciences, Dentistry,
and Pharmacy, Temple University, Philadelphia, Pennsylvania, and Consultant
in Regulatory Matters, New York, New York
Print Published: 10/12/2000 Hard Cover 752 pages |
Illustrated 5th Printing Print ISBN: 0-8247-0425-8
Description :
This newly revised and expanded reference examines United States law
and governmental policy affecting domestic and multinational pharmaceutical
manufacturing, recommending pragmatic ways to interpret and comply with
FDA Current Good Manufacturing Practice (CGMP) regulation and related
criteria, and focusing on geographical redistribution of manufacturing
facilities, accommodation of a diversity of regulatory and statutory
governance, adaptation to disparate human resources, and new growth
areas of manufacture and distribution of homeopathic remedies and dietary
supplements, in addition to the greater quality control required of
pharmacists and other authorized dispensers. Fifth Edition covers cross-licensing,
joint ventures, strategic alliances, mergers, acquisitions, and divestitures
that emphasize the necessity of maintaining quality control! |
US$ 135.00
Non-Member
US$ 122.00
progamma Club member
|
 |
Parenteral Quality Control
Sterility, Pyrogen, Particulate, and
Package Integrity Testing: Third Edition, Revised and Expanded
Edited by:
Michael J. Akers and
Dan Larrimore
Baxter
Pharmaceutical Solutions, LLC, Bloomington, Indiana, U.S.A.
Dana
Morton Guazzo
RxPax, LLC,
Bridegewater, New Jersey, U.S.A.
Reviews
"valuable, well-written, and easy-to-read" —Pharmaceutical
Technology
Description :
Describes the most recent breakthroughs in the validation and execution
of testing schemes for parenteral quality control. Emphasizes testing
methodologies for the evaluation of package integrity, finished product
contamination, and sterility.
|
US$ 165.00
Non-Member
US$ 148.50
progamma Club member
|
 |
BioPharmaceutical Process Validation
Edited by :
Gail Sofer
BioReliance, Inc. Rockville MD U.S.A.
Dane W. Zabriskie
Biogen Cambridge MA U.S.A.
Book | Print Published: 03/24/2000
Hard
Cover 400 pages | Illustrated 2nd Printing
Print ISBN: 0-8247-0249-2
Reviews
"...a well written
book which is full of scientific and development management information.
It is recommendable to everybody in the biopharmaceutical industry with
an interest in processes as well as to those still learning about the
industry." — European Journal of Pharmaceutics and Biopharmaceutics,
2000
|
US$ 150.00
Non-Member
US$ 135.00
progamma Club member
|
 |
Handbook
of Computer and Computerized System Validation for the
pharmaceutical Industry
By: Stephen Robert Goldman
Book | Print Published:
05/02/2003
Paperback 459 pages
Print ISBN: 1-4107-3744-6
Book Description :
Much has been written about "why" to validate. The
Handbook of Computer and Computerized System Validation for the Pharmaceutical
Industry is an SOP-centric explanation of "how" to validate. Creating
a state of sustainable compliance with FDA regulations including 21
CFR Part 11, Electronic Records; Electronic Signatures is daunting
task. This handbook follows FDA guidelines and "Best Industry Practices"
in defining the roles, responsibilities, and requirements of computer
and computerized system validation for the pharmaceutical, biotechnology,
and medical device industries. It details the requirements for Standard
Operating Procedures and Protocols for User Requirements, Functional
Requirements, Design Specifications, Installation Qualification, Operational
Qualification, and Performance Qualification. 21 CFR Part 11 Assessment
and validation gap analysis methods are prescribed to determine the
state of compliance of systems with current regulation. The! first
requirement of 21 CFR Part 11 is "Validation of systems to ensure
accuracy, reliability, consistent intended performance, and the ability
to discern invalid or altered records." This book explains how to
comply with this and other requirements of 21 CFR Part 11. |
US$ 85.00
Non-Member
US$ 76.50
progamma Club member
|
|
Type of Payment: For Credit Card Payment, 2.64% will be added to the total (for
check no charges will be added). |
|