ISPE Publications Catalog

T h e C o l l e c t i v e K n o w l e d g e o f G l o b a l Industry and Regulatory Experts

JULY JUL Y – De cember Baseline® Pharmaceutical Engineering Guides GAMP® Guidance Documents ISPE Guides and Good Practice Guides Investigational Products Resources Other Technical Resources

give your company foundation for compliance From promoting better understanding o regulations,, to detailing use o computerized regulations systems or quality and compliance, to providing a basic oundation or the design, construction, commissioning, commissioning, and validation o a manuacturing acility, these one-o-akind Guidance Documents are available only through ISPE. ISPE Guides result rom global collaboration and direct participation by global regulatory agencies, such as the US Food and Drug Admin istr atio ation n (FDA) ( FDA),, PIC/S, PI C/S, EMA, MHLA, JPMDA, and Health Canada to name a ew. ISPE’s Baseline ® Guide series was produced in partnership with the US FDA, and ISPE’s world-renowned GAMP ® 5: A Risk-Based Approach to Compliant GxP Computerized Systems engaged a task team o more than 70 subject matter experts and various regulatory authorities around the world, including US FDA, UK MHRA, Assa ps ( Fra France) nce) , an d Re gier ungsp räsi dium Darmstadt (Germany).

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New Member Only Oer................................................... ..... 14-15 Baseline® Pharmaceutical Engineering Guide Series Water and Steam Systems (Second Edition) ............................................ ............ 4 Sterile Product Manuacturing Facilities (Second Edition) ..................................... 5 Risk-Based Manuacture o Pharmaceutical Products (Risk-MaPP) ...................... 5 Oral Solid Dosage Forms (Second Edition) .............................................. ........... 6 Active Pharma ceutic al Ing redient s, a R evision o Bul k Pharmaceutical Chemicals ............................................... ......................... ....6 Biopharmaceutical Manuacturing Facilities ............................................. ............ 7 Commissioning and Qualifcation .................................................... .................... 7

GAMP® Guidance Documents GAMP® 5: A Risk-Based Approach to Compliant GxP Computerized Systems ..... 8 GAMP® Good Practice Guides: A Risk -Base d App roach t o GxP Proces s Cont rol Sy stems ( Secon d Edit ion) ... .. 9 A Risk Based Approa ch to Calibr ation Manage ment ( Second Editio n) ...... ..... ... 9 A Risk-Based Approach to Operation o GxP Computerized Systems A Co mpanio n Volume to GAM P ® 5 .................................................. .......... 10 Manuacturing Execution Systems A Str ategic and Pro gram M anagem ent Ap proach ......... ..... ...... ...... ..... ...... .. 10 Electronic Data Archiving ................................................... ........................... 11 Global Inormation Systems Control and Compliance ..................................... 11 IT Inrastructure Control and Compliance ...................................................... 11 Validatio n o L aborat ory Co mpute rized System s ...... ..... ..... ...... ..... ...... ...... ..... 12 A Risk-Based Approach to Compliant Electronic Records and Signatures ...... 12

Investigational Products Resources Introductory US Clinical Trial Materials Training Guide ........................................ 13 Investigational Materials Sample Retention Guide ............................................. . 13 Comprehensive Guide to Clinical Materials .............................................. .......... 13

ISPE Guides and Good Practice Guides

NEW! Special Series Pricing Now ISPE Members can take an additional 20% off select Guide Document Series. See center spread for details.

Ozone Sanitization o Pharmaceutical Water Systems ........................................ 16 Quality Laboratory Facilities ................................................... ........................... 16 ISPE PQLI® Guide: Part 3 – Change Management System as a Key Element o a Pharmaceutical Quality System .......................................... 17 Packaging, Labeling, and Warehousing Facilities ............................................. .. 17 Assessi ng the Parti culate Contai nment Pero rmance o Ph armace utical Equipment (Second Edition)............................................... ........................... 18 Comparator Management............................................ ..................................... 18 Interactive Response Technology ................................................... ................... 18 Project Management or the Pharmaceutical Industry ........................................ 19 ISPE PQLI® Guide: Part 1 – Realization using QbD Concepts and Principles....... 19 ISPE PQLI® Guide: Part 2 – Realization using QbD, Illustrative Example ............. 19 Applie d Risk Manage ment  or Co mmissio ning a nd Qua lifcat ion ...... ..... ..... ...... ... 20 Process Gases ............................................ .................................................... . 20 Science and Risk-Based Approach or the Delivery o Facilities, Systems, and Equipment ................................................... ........................... 21 Cold Chain Management ...................................................... ........................... 21 Heating, Ventilation, and Air Conditioning (HVAC) ............................................. . 22 Maintenance .............................................. .................................................... . 22 Good Engineering Practice ........................................... .................................... 22 Development o Investigational Therapeutic Biological Products ......................... 23 Commissioning and Qualifcation o Pharmaceutical Water and Steam Systems ................................................. .................................... 23

Other Publication Resources GMP Institute .............................................. .................................................... . 24 Regulation and Guidance Mini-Handbooks .............................................. .......... 24 Medical Device Quality Systems Manual. ................................................. .......... 24 Certifed Pharmaceutical Industry Proessional™ Study Guide ............................ 24 ISPE Subscriptions............................................... ............................................ 26

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elon Von Only

Baseline Parmaceical Egieerig ®

Gide Series Created in partnership with the US Food and Drug Administration (FDA), ISPE’s Baseline Guides oer practical answers to the complex, dynamic challenges acing acility designers today by addressing GMP and non-GMP regulations.

FOR NEW AND RENOVATED FACILITIES

Water and Steam Systems (Second Edition) The ISPE Baseline® Guide: Water and Steam Systems (Second Edition) is the only comprehensive guidance o its kind and aims to assist with the design, construction, operation, and maintenance o new water and steam systems that meet current Good Manuacturing Practices (cGMPs) and comply with existing regulations and related guidance. New chapters covering microbiological considerations, such as biolm ormation, use o sanitizers, sampling, testing, and control levels, as well as the overall impact o microbial considerations on unit operations and nished water have been added. The Guide also has been reviewed by the US Food and Drug Administration (FDA), and their comments have been taken into consideration in the nal version o the Guide. 264 pages December 2011

g o l a t a C s n o i t a c i l b u P E P S I

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The Guide was written by a global team o critical utilities experts with a combined experience o more than 500 years. Much o the team responsible or the original Water and Steam Systems Baseline Guide has returned to contribute to the revised Guide, providing continuity and longevity o vision to the Guide’s contents. Bound Item #: WAT1211

Bound or PDF Download Pricing:

Individual PDF Download Item #: WAT1211DL

Member $200/€155 New Member* $439/€365 Nonmember $465/€385

Sterile Product Manuacturing Facilities (Second Edition) The newly updated ISPE Baseline® Guide: Sterile Product Manuacturing Facilities is a complete revision o the original version, and contains recommendations to help acilitate compliance with the latest FDA and EMA guidance. The update is aimed at a truly international audience, as it incorporates a comprehensive tabulation, explanation, and comparison o the cleanliness designations ound in FDA, EMA, and ISO guidance documents, allowing or better harmonization in global acility design and a wider breadth o regulatory compliance internationally.

204 pages September 2011

Technical updates contained in the Guide include the use o RABS and isolator technology; acility design; best practices or terminally sterilized and aseptically processed sterile products; and updated guidance on quality attributes o construction and nishes solutions or dierent grades o acility. The Guide includes inormative diagrams and thorough text to explain and compare GMP requirements, providing a platorm or developing compliant solutions and allowing rms to ollow several dierent routes to reach a compliant solution. The new Sterile Product Manuacturing Facilities Baseline Guide consolidates all o ISPE’s latest best practice recommendations on sterile manuacturing acility design into one document. Bound Item #: STER0911


Individual PDF Download Item #: STER0911DL


The bound version is available in Japanese and Chinese. To purchase the Japanese, contact the Japan Aliate at www.ISPE.org.gr.jp. To purchase the Chinese version, visit www.ISPE.org/Publications.

Related Webinar:

• SterileGuide“MeettheAuthors”

Risk-Based Manuacture o Pharmaceutical Products (Risk-MaPP) The ISPE Baseline® Guide: Risk-Based Manuacture o Pharmaceutical Products (RiskMaPP) provides a scientic risk-based approach based on ICH Q9 to manage the risk o cross-contamination to maintain product quality and operator saety. This allows the selection o the appropriate risk control strategies to be implemented on a case-by-case basis to maintain patient saety and assure product quality. This Guide provides a process that allows manuacturer’s to assess risk and determine where control strategies are necessary to meet acceptable limits or cross-contamination. The control strategies to manage risk can vary rom administrative to ull dedication or segregation. Typically, some combination o control strategies may be necessary.


This Risk-MaPP Guide is intended to provide proessionals in the pharmaceutical industry with a consistent approach on setting acceptable limits to assess the potential o crosscontamination causing an undue risk to patient saety. This approach is intended to allow manuacturers to contain manuacturing cost while acilitating sae and aordable drug product. This Guide should be used in conjunction with local and/or applicable (multinational manuacturing platorms) regulatory requirements, and other guidance documents already available to the pharmaceutical manuacturing industry. Bound Item #: RISK0910


Individual PDF Download Item #: RISK0910DL


The bound version is available in Japanese. To purchase the Japanese, contact the Japan Aliate at www.ISPE.org.gr.jp.

Related Webinars:

• RiskManagementFollow-Through • Risk-MaPP:WhatisitandWhyYouNeedit! * New Member fee includes one-year membership in ISPE -- a $239 value. See order form for details.


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Oral Solid Dosage Forms (Second Edition) This revision — the latest ISPE publication reviewed by the US FDA — updates content rom the original Oral Solid Dosage Forms Baseline® Guide to current industry standards, practices, and regulatory requirements. Specically, it addresses the latest interpretation o GMP requirements, as well as a risk-based approach to regulatory compliance relating to the design, construction, and validation o the OSD manuacturing acility. The product and processing chapter has been expanded with detailed discussion o each critical unit operation and new technological trends, such as continuous processing and implementation o process analytical technology. The Guide provides a comprehensive view o best practices available in the pharmaceutical industry or oral solid manuacturing acility design and construction. A liecycle approach to project management is emphasized. 188 pages November 2009

Bound Item #: OSD1109


Individual PDF Download Item #: OSD1109DL


The bound version is available in Japanese and Chinese. To purchase the Japanese, contact the Japan Aliate at www.ISPE.org.gr.jp. To purchase the Chinese version, visit www.ISPE.org/Publications.

Related Webinar:

• NewTechnologiesinOSD

Active Pharmaceutical Ingredients, a Revision o Bulk Pharmaceutical Chemicals

BONUS WHITE PAPER WITH BOUND PURCHASE

188 pages June 2007

This revised Guide builds on the original principles o ISPE’s Baseline® Guide Volume 1, Active Pharmaceutical Ingredients (originally entitled Bulk Pharmaceutical Chemicals). It also incorporates and builds on new regulations and guidance, such as: ICH Q7, ICH Q9, GAMP® 4, 21 CFR Part 11, Guidance or Industry, Sterile Drug Products Produced by Aseptic Processing – Current Good Manuacturing Practice (cGMP), FDA Drat Guidance or Industry PAT – Framework or Innovative Pharmaceutical Manuacturing and Quality Assurance, and much more. BONUS: With purchase o API, you will receive the white paper, A Risk-Based Approach

to Dening Levels o Protection within API Facility Design: The Concept o Briefy Exposed (Briefy Open), by Stan Newberger and Dr. Trish Melton. This white paper expands and claries a new concept introduced in the Guide. Bound Item #: API0607


Individual PDF Download Item #: API0607DL




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Biopharmaceutical Manuacturing Facilities This Guide is a reerence or design, construction, commissioning, and qualication o new acilities or biopharmaceutical Active Pharmaceutical Ingredients (APIs), also known as drug substance. The Guide covers in-line process analytical measurement and control, the use o disposable equipment, enhanced strategies or automation, and alternative methods or protecting the integrity o the product. Produced by Task Teams composed o more than 100 regulatory and industry leaders, the Guide addresses US GMPs, while the GMPs o other countries and regions are covered in the appendices. Bound Item #: BIO0604 Individual PDF Download Item #: BIO0604DL

196 pages July 2004

Bound/CD Set Item #: BIOELEC


Bound/CD Set Pricing:



Related Webinar:

• FDADiscussesBiopharmGuide

Commissioning and Qualifcation This Guide ocuses on engineering approaches and practices or timely, cost-eective delivery o manuacturing acilities, specically addressing the process o designing, constructing, commissioning, and qualiying the acilities, utilities, and equipment regulated by the FDA or other health authorities. The Guide has incorporated comments rom industry representatives, FDA eld investigators, and personnel rom the FDA’s Center or Drug Evaluation and Research (CDER). The Guide is intended primarily or regulatory compliance in the US market, and it may be helpul to manuacturers or meeting European requirements. Bound Item #: CQ0101 Individual PDF Download Item #: CQ0101DL

142 pages March 2001

Bound or PDF Download Pricing :


Bound/CD Set Item #: CQELEC

Bound/CD Set Pricing:


The bound version is available in Japanese. To purchase the Japanese, contact Japanese Aliate at www.ISPE. org.gr.jp.

New Value Added Content

In an eort to urther assist companies in transitioning rom traditional impact assessment based qualication approaches to ICH Q9 QRM based approaches ound in ASTM E2500 and the ISPE FSE Guide, ISPE will now include Appendix 2 rom the ISPE Guide: Science and Risk-Based Approach or the Delivery o Facilities, Systems, and Equipment with purchases o the Baseline® Guide: Volume 5 – Commissioning and Qualifcation. The

Appendix contains an update or use with the Commissioning and Qualication Impact Assessment Chapter o the Baseline® Guide, based on the experiences o project teams and considers the benets and application o science-based process understanding. Related Webinar:

• TheKeytoSuccessfulCommissioningandQualication

* New Member fee includes one-year membership in ISPE -- a $239 value. See order form for details.


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GAMP Gidace Docmes ®

GAMP® 5 GAMP ® 5: A Risk-Based Approach to Compliant GxP Computerized Systems provides pragmatic and practical

industry guidance that aims to achieve compliant computerized systems that are t or intended use in an ecient and eective manner, while also enabling innovation and technological advance.

GAMP® Good Practice Guides

Refecting current regulatory expectations and good practices, the GAMP series o Good Practice Guides help to narrow interpretation o regulatory standards or improved compliance and quality, eciency, and cost reductions.

GAMP® 5: A Risk-Based Approach to Compliant GxP Computerized Systems The new GAMP ® 5: A Risk-Based Approach to Compliant GxP Computerized Systems provides pragmatic and practical industry guidance that aims to achieve compliant computerized systems that are t or intended use in an ecient and eective manner, while also enabling innovation and technological advance. The revised Guide describes a fexible risk-based approach to compliant GxP regulated computerized systems, based on scalable specication and verication. A robust quality risk management process based on ICH Q9 principles is central to the approach. GAMP ® 5 also contains new inormation on outsourcing, electronic batch recording, end user applications (such as spreadsheets and small database applications), and patch management.

356 pages February 2008

CD accompanying the Guide provides supporting materials, including dierences between GAMP® 4 and GAMP® 5, key diagrams, templates, orms, example documents, and background inormation. (CD is Windows compatible only.) Bound Item #: 5BOUND


Individual PDF Download Item #: 5BOUNDDL


The bound version is available in Japanese, French, German, and Chinese. The electronic version is available in French and German. To purchase the Japanese version, contact the Japan Aliate at www.ISPE.gr.jp or details. To purchase either the French, German, or Chinese versions, visit www.ISPE.org/Publications.

Related Webinars:


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• AGAMP® Interpretation - Annex 11 • GAMP® 5 Series: Change Management: Computerized Systems including Patch and Upgrade Management • GAMP® 5 Series: Changing the Industry • GAMP® 5 Series: IT Inrastructure Compliance and Control • GAMP® 5 Series: Managing Quality in an Outsourced Environment • GAMP® 5: End-User Applications • LifeAfterGAMP® 5: What Comes Next?

A Risk-Based A pproach to GxP Process Control Systems (Second Edition) This GAMP ® Good Practice Guide: A Risk-Based Approach to GxP Process Control Systems is a revision o the GAMP ® Good Practice Guide: Validation o Process Control Systems. It provides guidance and examples on the application o the principles and ramework o GAMP ® 5: A Risk-Based Approach to Compliant GxP Computerized Systems to a wide range o systems, rom basic instruments to large, complex, distributed control systems. This Guide aims to achieve process control systems that are t or intended use and compliant with applicable regulations; providing recommended good practice based on a lie cycle approach or the development, maintenance, and management o process control systems.


The Guide applies science-based Quality Risk Management, as described in ICH Q9 and GAMP® 5. It describes the system lie cycle rom concept to retirement, providing a high level overview o the approach together with guidance on how activities might be scaled based on risk to product quality, system novelty, and complexity as well as other project specic actors. The Guide ocuses on those eatures that are in some way special to process control systems and distinguishes three types o process control systems. These are intended to be used in conjunction with GAMP ® categories to highlight system scale and complexity, and to allow a common basis or presenting examples across a range o systems. Examples are introduced in the body o the document, and expanded as appropriate in the Appendices. Bound Item #: GGPGPCS2


Individual PDF Download Item #: GGPGPCS2DL


A Risk-Based Approach to Calibration Management (Second Edition) Calibration is an essential element in ensuring compliance in the pharmaceutical and associated regulated lie science industries. To ensure success, calibration should be managed eectively, by appropriately qualied and competent personnel. I neglected, calibration is capable o compromising product and process quality, acility, saety, environmental and patient saety, and dramatically increasing costs.

124 pages November 2010

The GAMP ® Good Practice Guide: A Risk-Based Approach to Calibration Management (Second Edition) provides guidance in setting up a calibration management system, which will give a structured approach to instrument risk assessment, calibration program management, documentation, and corrective actions, essential to regulatory compliance. The Guide has been updated to address the changing environment, while still satisying international GxP regulatory expectations, current at time o publication. The scope has been widened to include related industries, laboratory, and analytical instrumentation. Bound Item #: GGPGCALMGMT2


Individual PDF Download Item #: GGPGCALMGT2DL

Member $145/€115 New Member* $384/€325 Nonmember $405/€345 g o l a t a C s n o i t a c i l b u P E P S I


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A Risk-Based Approach to Operation o GxP Computerized Systems, A Companion Volume to GAMP® 5 Regulated computerized systems should be maintained in a demonstrable state o control and in accordance with regulatory requirements. Recovery rom a ailure to maintain control o a regulated system during the operation phase can be both time-consuming and expensive, and increase the risk to data integrity, product quality, and patient saety. During the operational lie o a GxP system, regulators usually ocus on the integrity, consistency, and completeness o controls required to maintain compliance.

216 pages January 2010

This Guide highlights the importance o the operation phase o the system liecycle, when the return on investment or the signicant time and resource expended in implementing new computerized systems can be achieved. The Guide will help regulated organizations achieve regulated computerized systems that are t or intended use and compliant with applicable regulations and provides comprehensive guidance or maintaining control o regulated systems throughout their operational lie, including to: When applied as intended, this Guide can provide detailed direction on the required control processes which orm a substantial part o an appropriate Quality Management System (QMS). Bound Item #: GGPGOGCS


Individual PDF Download Item #: GGPGOGCSDL


Manuacturing Execution Systems - A Strategic and Program Management Approach The Guide uses a complete liecycle approach to the development and use o MES or regulated manuacturing as a collection or domain o manuacturing related unctions that integrates business and process controls, inormation fow, and human interaction to acilitate the operation o an organization. It collects and integrates inormation and knowledge rom many disciplines and sources into a single comprehensive guideline and aims to enable organizations to:



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•Shortendevelopmentandimplementationtimesbyleveragingindustryexperience •Implementdesignandtestingmethodsthatimprovelifecycleactivities •Buildcomplianceintotheprocess •Provideimprovedunderstandingandcoordinationofthecompletemanufacturing environment •Reducetheriskofprojectfailure •Betterbalancecostsofimplementationandoperation •Clarifyqualityunitresourcesrequiredforongoingsystemoperationalsupport Bound Item #: GGPGMES


Individual PDF Download Item #: GGPGMESDL


Electronic Data Archiving The GAMP ® Good Practice Guide: Electronic Data Archiving seeks to provide a rational and scaleable approach to electronic data archiving through the development o an archiving strategy. The implementation o this strategy should help organizations achieve and maintain regulatory compliance, and to eectively manage electronic records over the long term. This Guide is intended as a supplement to the main GAMP ® Guide and is read in conjunction with the GAMP ® Good Practice Guide: Electronic Records and Signatures, which provide additional relevant inormation.

92 pages August 2007

Bound Item #: 4EDA


Individual PDF Download Item #: 4EDADL


Global Inormation Systems Control and Compliance This Guide provides an understanding o the issues aced by teams that are tasked with completing a global deployment o an IT system, in particular, to provide some insight into addressing issues o control and regulatory compliance eciently and eectively. The Guide encompasses a wide range o regulations and guidelines, including US FDA regulations and GPGs, relevant sections o EU GMPs, PIC/S Guidance, Health Canada GMP regulations, and ICH Guidelines. Bound Item #: 4GIS


Individual PDF Download Item #: 4GISDL



IT Inrastructure Control and Compliance This Guide provides comprehensive guidance on meeting current regulatory expectations or compliant IT Inrastructure platorms, including the need to identiy, qualiy, and control those aspects impacted by GxP. Bound Item #: 4IT


Individual PDF Download Item #: 4ITDL






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Validation o Laboratory Computerized Systems This Guide ocuses on laboratory computer systems or regulated healthcare industries subject to Good Manuacturing Practice (GMP), Good Laboratory Practice (GLP), or Good Clinical Practice (GCP). Building upon the GAMP® 4 sotware categories, the Guide provides a rational, scalable approach to the validation o laboratory computerized systems, taking into account systems categorization, and risk assessment processes. Bound Item #: 4VLCS


Individual PDF Download Item #: 4VLCSDL



96 pages April 2005

A Risk-Based Approach to Com pliant Electronic R ecords and Signatures Accuracy and integrity o records and data is essential throughout the product lie cycle, rom research and development through pre-clinical studies, clinical trials, production and quality control to marketing. This Guide provides urther guidance on this topic, and should be read in conjunction with GAMP ® 5. This Guide provides comprehensive guidance on meeting current regulatory expectations or compliant electronic records and signatures, emphasizing well-documented, validated systems, and the application o appropriate operational controls. The Guide applies a risk-based approach to implementation.



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Bound Item #: 4ERS


Individual PDF Download Item #: 4ERSDL



Investigational Prodc Resorces

Introductory US Clinical Trial Materials Training Guide This Guide is designed to amiliarize new clinical trial materials proessionals with the terms and related inormation they need or success. The ocus o this Guide is clinical trial material supply units operating under the rules o the US FDA. Item #: CMGUIDE

Pricing:

Member Nonmember

$15/€12 $25/€20

44 pages October 2002

Investigational Materials Sample Retention Guide This Guide, a supplement to the Introductory US Clinical Trial Materials Training Guide, assists users in determining quantity and retention time or sample products. Item #: CMRETGD

Pricing:

Member Nonmember

$7/€6 $17/€14

July 2003

Comprehensive Guide to Clinical Materials

A Handbook or Training Clinical Materials Proessionals The Guide is designed to provide a valuable tool or the development o in-house training sessions or advanced training, building on the topics covered in the Introductory US Clinical Trial Materials Training Guide. It may be used in a classroom setting, and then by attendees to gain more in-depth knowledge and as a reerence source or uture use. Bound Item #: CMHB2006 Individual PDF Download Item #: CMHB2006DL



120 pages July 2006 * New Member fee includes one-year membership in ISPE -- a $239 value. See order form for details.


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Special Offer for ISPE Memers Ol Members can take advantage o ISPE’s ull depth o knowledge on these disciplinesataspecialdiscountprice.BecomeanexpertandSAVE!

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With the rapid changes in approaches or Commissioning and Qualication (C&Q) currently underway in the pharmaceutical industry, it’s becoming common to nd companies at all points o the continuum when it comes to C&Q best practices. The ISPE C&Q Guide Series covers the entire spectrum o C&Q approaches, rom continuing with the Baseline ramework to ull implementation o Quality Risk Management and ASTM E2500.

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Waer Series The ISPE Water Series brings together guidance on design, construction and maintenance o water and steam systems with specic inormation on ozone sanitization systems or high purity GMP pharmaceutical water systems. The Series also includes guidance on gas systems to support production gases that come into direct contact with process streams.

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PQLI ® Series Parts 1, 2, and 3 o the ISPE Product Quality Liecycle Implementation (PQLI) Guide Series describe the concepts and principles o Quality by Design (QbD), the potential product liecycle approaches to the change management system element o a pharmaceutical quality system, and provide an example practical approach on how to implement QbD principles or an oral solid dosage product containing a small molecule. * New Member fee includes one-year membership in ISPE -- a $239 value. See order form for details.


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ISPE

Guides and Good Practice Guides Guide

Good Practice Guide

ISPE Guides

ISPE Good Practice Guides

ISPE Guides oer practical advice on regulatory initiatives by providing eective, cost-ecient approaches and encouraging innovation and technological advances while achieving regulatory compliance.

ISPE Good Practice Guides (GPGs) provide inormation or advice on a particular topic area and explain underlying technical principles and suggest solutions in an area where no single answer is correct and where several outcomes may be possible.

Ozone Sanitization o Pharmaceutical Water Systems The ISPE Good Practice Guide: Ozone Sanitization of Pharmaceutical Water Systems provides important insight into the design and use o pharmaceutical ozone sanitization systems, and is the frst industry Guidance Document to take a holistic view o these issues. The Guide provides an overview o ozone sanitization systems, including regulatory considerations and other actors companies should take into account when deciding to use ozone vs. other sanitization approaches. It discusses specifc system requirements, as well as associated advantages and disadvantages o using ozone as a water sanitization method. The Guide helps companies better understand what ozone systems are, why they can be a saer, more efcient and more cost-eective way to sanitize pharmaceutical water, and how they can be incorporated into both new and retroftted acilities.

144 pages August 2012

Bound Item #: IGPGOZONE


Individual PDF Download Item #: IGPGOZONEDL


Quality Laboratory Facilities


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ISPE has produced the industry’s frst Guidance Document to establish a baseline or the design o Quality Laboratory Facilities. The ISPE Good Practice Guide: Quality Laboratory Facilities is a comprehensive guide to defning design guidelines or Quality Laboratories supporting GxPregulated acilities producing pharmaceutical products or human and animal applications. It provides a step-by-step process that guides the reader through all phases o producing a quality lab and all the actors that must be considered at each phase. The Guide helps save time and money by acilitating eective communication between lab owners, engineers and builders about the unction, operation and design parameters that must be met.

180 Pages August 2012

Bound Item #: IGPGQLF


Individual PDF Download Item #: IGPGQLFDL


Change Management System as a Key Element o a Pharmaceutical Quality System The ISPE PQLI Guide: Part 3 – Change Management System as a Key Element o a Pharmaceutical Quality System, is the only change management guide written expressly or the pharmaceutical industry. It provides practical, real-world strategies or implementing the change management recommendations o ICH Q10. The Guide contains inormation to help translate the holistic approach described in Q10 into an actionable plan and can help companies update and improve their change management practices.

56 pages June 2012

The PQLI Guide on Change Management outlines potential product liecycle approaches to the change management system o a Pharmaceutical Quality System (PQS). It provides clear guidance on achieving compliant and consistent change management systems and describes how to implement compliant change management systems within a PQS. PQLI Part 3 – Change Management can be used in conjunction with the frst two PQLI Guides as part o a larger Quality by Design approach, or as a stand-alone change management manual Individual PDF Download Item #: PQLI3DL

PDF Download Pricing:


Packaging, Labeling, and Warehousing Facilities The ISPE Good Practice Guide: Packaging, Labeling, and Warehousing Facilities is the industry’s only guidance relating to the design, construction and commissioning and qualication o packaging, labeling and warehousing (PACLAW) acilities. The Guide helps companies meet CGMP requirements or these types o acilities while avoiding product adulteration, product mix-up, label mix-up and misbranding. Companies can use this Guide to learn how to ensure that their PACLAW processes are ecient, compare their processes to established best practices and demonstrate compliance to regulatory agencies.

104 pages May 2012

This Guide presents an approach to satisying CGMPs while providing realistic solutions to business and operational concerns. It addresses Quality by Design principles and establishes consistent guidelines that can be incorporated into the design and/or reconguration o PACLAW acilities. It covers acility design issues or most primary packaging operations, such as lling o the dosage orm in the immediate container/ closure system, and other packaging, labeling and warehousing processes. The Guide also provides direction on how to comply with the FDA’s systems-based approach with a riskbased inspectional model as it relates to PACLAW acilities. Bound Item #: IGPGPACLAW


Individual PDF Download Item #: IGPGPACLAWDL




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Assessing the Particulate Containment Perormance o Pharmaceutical Equipment (Second Edition) The ISPE Good Practice Guide: Assessing the Particulate Containment Perormance o Pharmaceutical Equipment (Second Edition) has been updated to address a broader selection o containment technologies and processing equipment. It will provide technical guidance and consistent methodologies or evaluating the particulate containment perormance (particulate emissions) o pharmaceutical equipment and systems. This Guide aims to dene current good practices, providing inormation to allow organizations to benchmark their practices and improve on them. Specically, the Guide provides a methodology to derive data associated with handling o pharmaceutical ingredients that is useul in the assessment o potential risks.

104 pages May 2012

Bound Item #: IGPGAPC2


Individual PDF Download Item #: IGPGAPC2DL


Comparator Management The ISPE Good Practice Guide: Comparator Management is the pharmaceutical industry’s rst-ever resource or comparator processes. It has been developed to use as a central reerence source that establishes strategic and tactical considerations related to comparator sourcing. It identies good practices or making sourcing decisions, including how to set up a good sourcing team. The Guide also discusses good practices or blinding and releasing a comparator or use. The Guide will also explain the risks involved with ineective comparator methods, and provide companies with strategies or avoiding the costs, delays and potential case study inaccuracies that might result rom aulty comparator management.

84 pages March 2012

Bound Item #: IGPGCMGMT


Individual PDF Download Item #: IGPGCMGMTDL


Interactive Response Technology Interactive response technology is a tool that can be used to support multiple business processes, and this Guide describes how the pharmaceutical industry can apply the technology to support various clinical trial activities. The Guide provides guidance on how to: successully implement an interactive response technology to manage key clinical trial activities, particularly expiry date management and program pooling; ensure robustness o the technology, contributing to its eectiveness and reliability; and communicate and oster a standardized, industry-wide approach to critical unctionality o Interactive Response Technology when used in managing investigational medicinal product g o l a t a C s n o i t a c i l b u P E P S I

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Individual PDF Download Item #: IGPGIRTDL

PDF Download Pricing:


Project Management or the Pharmaceutical Industry The ISPE Good Practice Guide: Project Management or the Pharmaceutical Industry provides good practice approaches which promote the successul integration o GxP with relevant project management activities to ensure that compliance risk is managed eectively and proactively. The Guide discusses: the tools and techniques supporting project delivery, the lie cycle o a typical project in the pharmaceutical industry, and how compliance to pharmaceutical industry regulations is integrated with the project lie cycle. Bound Item #: IGPGPM


Individual PDF Download Item #: IGPGPMDL



Product Realization using QbD, Concepts and Principles Product Quality Liecycle Implementation (PQLI® ) rom Concept to Continual Improvement Part 1 – includes the topics o Criticality, Design Space, and Control Strategy and

addresses product and process development, transer to, and establishment o, commercial manuacture using science- and risk-based approaches. Bound Item #: PQLI1


Individual PDF Download Item #: PQLI1DL


Related Webinar:

• ProductQualityLifecycleImplementation® (PQLI® ) 101: Vision, Status and Next Steps 188 pages November 2011

Product Realization using QbD, Illustrative Example Product Quality Liecycle Implementation (PQLI® ) rom Concept to Continual Improvement Part 2 – presents the small molecule case study developed by the ISPE PQLI ® teams. This

case study provides details o the application o the approaches to product and process understanding using quality risk management. Part 2 also reers to the many case studies in the public domain and uses ICH guidelines Q8 (R2), Q9, Q10, together with other relevant ICH guidelines. Bound Item #: PQLI2


Individual PDF Download Item #: PQLI2DL


Related Webinars:


• ProcessAnalyticalTechnology(PAT)UsedforPQLI® and QbD: Implementation Update, Examples, and Discussion • ProductQualityLifecycleImplementation(PQLI® ): Focusing on Q10 • ProductQualityLifecycleImplementation(PQLI® ): Regional Regulatory Experiences



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Applied Risk Management or Commissioning and Qualifcation The ISPE Good Practice Guide: Applied Risk Management in Commissioning and Qualifcation describes how organizations can move rom established baseline practice to a more ecient science- and risk-based ramework. It illustrates the application o Quality Risk Management to traditional commissioning and qualication practices, linking traditional terminology and approaches to the newer science- and risk-based specication and verication terminology and approaches applied in ICH Q8, Q9, and Q10, ASTM E2500, and ISPE Guide: Science and Risk-Based Approach or the Delivery o Facilities, Systems and Equipment.


The approach described in the ISPE Good Practice Guide: Applied Risk Management in Commissioning and Qualifcation allows companies to achieve the benets o a scienceand risk-based model by outlining bridging strategies or organizations with well-established qualication-based Quality Management Systems and providing a roadmap showing the spectrum o potential approaches or this transition. Bound Item #: IGPGARMCQ


Individual PDF Download Item #: IGPGARMCQDL


Process Gases The ISPE Good Practice Guide: Process Gases aims to dene current good practices within pharmaceutical manuacturing applications, providing inormation to allow organizations to benchmark their practices, and improve upon them. The Guide ocuses on dening cost eective engineering approaches and practices used to deliver a process gas systems or a manuacturing acility in a timely manner that will meet its intended purpose. Inormation is provided on how to avoid increasing acility installation and operational costs.

108 pages July 2011


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Specically, the Guide addresses the process o designing, constructing, commissioning, and qualiying a process gas system regulated by the FDA or other regulatory authority, such as the EMA. The Guide also addresses international guidelines and regulations. The Guide aims to clariy gas system issues critical to product quality or the production o biopharmaceutical and pharmaceutical drug substances and drug products. The Guide promotes science and risk-based to provide an eective basis or the planning, construction, commissioning, and qualication processes or gas systems used to support production. Bound Item #: IGPGPGAS


Individual PDF Download Item #: IGPGPGASDL


Science and Risk-Based Approach or the Delivery o Facilities, Systems, and Equipment The successul delivery o manuacturing acilities regulated by various authorities, poses signifcant challenges to manuacturers, engineering proessionals, and equipment suppliers. The ISPE Guide: Science and Risk-Based Approach for the Delivery of Facilities, Systems, and Equipment provides direction to industry on the implementation o a science- and riskbased approach or demonstrating that pharmaceutical and biopharmaceutical acilities, systems, equipment, and associated automation are ft or intended use and comply with regulatory requirements.

120 pages June 2011

The aim o the Guide is to acilitate the translation o the scientifc knowledge about the product and process into documented specifcation, design, and verifcation o acilities, systems, and equipment. Specifc implementation guidance is given on meeting the expectations o global regulators and is compatible with ICH documents (Q8 (R2), Q9, and Q10) and ASTM E2500-07. Bound Item #: IGFSE


Individual PDF Download Item #: IGFSEDL


Related Webinar:

• Baseline® Guide 12 Overview

Cold Chain Management Increasing volumes o cold products, the complexity o these products, and the complexity o the associated supply chain are causes or concern. Organizations need adequate control over cold chain o pharmaceutical and biopharmaceutical distribution systems. ISPE recognized the need or guidance in this area. A dedicated team o subject matter experts rom across the pharmaceutical and biopharmaceutical industries developed the ISPE Good Practice Guide: Cold Chain Management.

140 pages May 2011

This Guide provides tools and strategies or Cold Chain Management and to complement work by the Guidance or Temperature Controlled Medicinal Products. It helps to develop, establish, document, implement, maintain and improve industry good practice or product requiring controlled cold conditions. The Guide is intended to provide practical guidance to assist in the specication, design, commissioning and verication o the xed and passive systems within the cold chain. The Guide is intended to provide a robust cost eective system to ensure sae, eective product is received by the end users. The Guide covers the process rom the point o entry into the manuacturers’ controlled temperature storage acility ater being packaged through delivery to the distributor or customer premises. Bound Item #: IGPGCCM


Individual PDF Download Item # IGPGCCMDL


Related Webinar:

• DevelopmentandQualicationofaRobustColdChainLogisticsSolutionforBulkBiologics



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Heating, Ventilation, and Air Conditioning (HVAC) HVAC systems can be critical systems that aect the ability o a pharmaceutical acility to meet its objective o providing sae and eective product to the patient. The ISPE Good Practice Guide on HVAC provides designers and the project team with suggestions to help determine the user requirements and the unctional design that dene the acility’s objectives. It also provides options to be considered in creating a design that has low liecycle cost and that is sustainable. Bound Item #: IGPGHVAC


Individual PDF Download Item #: IGPGHVACDL


Related Webinars:


• HVACandUtilities:SpecialRequirements • HVAC:PracticalGuidanceforGMPFacilities

Maintenance This Guide provides practical solutions and tools or ensuring quality and compliance o maintenance operations in a regulated industry. Covering current and established practices, this Guide helps achieve technical and regulatory accuracy and cost-eective compliance in a new or existing maintenance program or eective strategy and eciency. Oering maximum fexibility, this Guide helps to clearly dene roles and responsibilities across cross-unctional areas and recommends a systematic approach aimed at continuous improvement o maintenance operations.

108 pages May 2009

Bound Item #: IGPGMAINT


Individual PDF Download Item #: IGPGMAINTDL


The bound version is available in Japanese. To purchase the Japanese, contact Japanese Aliate at www.ISPE.org.gr.jp.

Related Webinars:

• ISPEGoodPracticeGuide:Maintenance-HowtoDevelopacGMPMaintenanceProgram or Regulatory Compliance • TheNewMaintenanceGoodPracticeGuide

Good Engineering Practice Good Engineering Practices (GEPs) consist o proven and accepted engineering methods, procedures, and practices that provide appropriate, cost-eective, and well-documented solutions to meet user-requirements and compliance with applicable regulations. GEP underpins activities in the day-to-day operations and orward planning o a pharmaceutical business. The adoption o this methodology leads to a balance o expenditure and activity. In addition, GEP documentation can be leveraged to support verifcation work. This Guide brings a wealth o inormation on GEPs and provides benchmarking tools o current company practices against what is considered industry good practice. g o l a t a C s n o i t a c i l b u P E P S I

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The ASTM standard (E2500) builds on the concepts o GEPs and has substantial implications or reductions in cost and time or pharmaceutical capital investment projects. 196 pages December 2008

Bound Item #: IGPGGEP


Individual PDF Download Item #: IGPGGEPDL


Development o Investigational Therapeutic Biological Products This Guide will consider the major issues that will conront a biopharmaceutical company in moving therapeutic biological products rom the laboratory to the clinic and beyond. The Guide is intended to provide readers with an understanding o issues surrounding product and process development, manuacturing, investigational product supply chain management, quality control/quality assurance, and global regulatory requirements or biopharmaceuticals. Bound Item #: IGPGBIOL


Individual PDF Download Item #: IGPGBIOLDL



Commissioning and Qualifcation o Pharmaceutical Water and Steam Systems ThisGuideprovidesanalternativeapproachbasedon“riskassessment”principlesand “processunderstanding”forthecommissioningandqualicationofdirectimpactwaterand steam systems.

Bound Item #: IGPGCQWS


Individual PDF Download Item #: IGPGCQWSDL




Membership as is eefis ISPE Members are better informed and better connected than their industry colleagues. Members also enjoy significant discounts on ISPE Guidance Documents, Conference Registrations, Training and Online Learning, and much more. Visit www.ISPE.org/Membership to learn more about how joining ISPE can help give you a competitive edge.



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Other Plicaio Resorces The original GMP Institute DVDs are no longer available and have been updated to include current content in an online training course ormat. Making GMP a liestyle is now easier to access and implement through the US FDA’s Systems-Based Inspection Approach training series o 30 to 60-minute online courses.

inormation to ensure correct application o cGMP regulations or: • Quality Systems •FacilitiesandEquipmentSystems •LaboratoryControlSystems •MaterialsSystems •PackagingandLabelingSystems •ProductionSystems Also available is a 60-minute Industry Overview: Drug Dosage Forms online course to review the basics. It is rom this perspective that we condently assert:

Each course provides pre- and post-assessments, downloadable course presentations or note taking, learning reviews highlighting important points, and hot-links to regulatory and industry

Our Commitment is to Your Success!

Visit www.ISPE.org/GMPResources or more inormation.

Regulation and Guidance Mini-Handbooks These handy pocket-size booklets are an ideal way to keep everyone inormed o US FDA and ICH regulations and guidelines. Blood (21 CFR Part 606)

Food (21 CFR Part 110)

Item #: GMP037 Pricing: $5/€4


Dietary Supplements (21 CFR Part 111)

Medical Device (21 CFR Part 820)



Electronic Records; Electronic Signatures (21 CFR Part 11)

Pharmaceutical (21 CFR Parts 210, 211)


Item #: GMP035 Pricing: $5/€4 ICH Q7 - APIs

ICH Q8R2 - Pharmaceutical Development

Item #: GMP048 Pricing: $5/€4 ICH Q9 - Quality Risk Management

Item #: GMP046 Pricing: $5/€4 ICH Q10 - Pharmaceutical Quality



Certifed Pharmaceutical Industry ProessionalTM Study Guide

Medical Device Quality Systems Manual

The electronic Study Guide provides a detailed description o knowledge elements to be included in the CPIP™ certifcation program examination. This Document contains reerences in the public domain, which can be used to prepare or the examination and/or as an everyday work Reerence tool.

This manual is US FDA’s interpretive guide to the Quality System Regulation. It covers aspects o manuacturing including the design control requirements and contains model procedures and sample orms. This is a must-have or every medical device manufacturingplant! g o l a t a C s n o i t a c i l b u P E P S I

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Item #: GMP039

Item #: CPIPSTUDY5DL

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ISPE Subscriptions Turn your desktop into a digital library, anytime and anyplace. ISPE’s new subscription service gives you unlimited online access to a custom set of ISPE Guidance Documents for your auditing, compliance, regulatory, engineering maintenance and quality needs. Find, read, search, save and print the most current docs available. Enjoy one-click access to historical, related and referenced materials while you work. Pay only for documents you need.

Add Real Value for Your Organization Unlimited enterprise access Your subscription travels with you anytime, anywhere – in the ofce, in the plantor on the road. Free automatic updates No more wondering if you have the most current information, no more expensive rework or retooling. Optional third-party content from CLSI, BSI, AAMI, DIN and more Get the standards content you need from t op industry sources. Fast intuitive Web interface Say goodbye to an inefcient paper library. Digital distribution saves time.

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isPe iD #________________________________Pl  opl pulon log o pol gdng un, doun, nd und.

F N _________________________________________________ mi ________L N_________________________________________________________ Jo tl ________________________________________________________________________________________________________________________________ copny ______________________________________________________________________________________________________________________________ bun add (No PO box) _______________________________________________________________________________________________________________ cy _________________________________________________________________ s/Povn___________ Zp+4/Pood ___________________________ couny ___________________________________el add _________________________________________________________________________________ bun tl __________________________________________________________ bun Fx ______________________________________________________ i wh o kp y d onfdnl nd   gvn only o u y isPe nd  lol afl nd chp.

Yes, I elect ISPE industry membership (a $239 value). Membership is non-transferable. Contact ISPE see if you qualify for reduced Membership rates. PDF downloads are available or fve (5) days only rom date o purchase. There are NO REFUNDS on downloadable PDF documents.

QTY.

TITLE

ITEM #

1N/A

UNIT PRICE ($ OR €)

ISPEIndustryMembership(OneYear)$239/ €210*

TOTAL Choose membership price or all items

PUBLICATIONS SUBTOTAL

Item#CPIPSTUDY3DL

Certied Pharmaceutical Industry Proessional TM Study Guide (Download Only)

Member Price $40/€32 Nonmember Price $60/€48 CPIP Subtotal

Payment Method

SUBTOTAL (Publications Subtotal + CPIP Subtotal )

Payment or credit card billing inormation MUST accompany order.

Emerging Economy Discount Check #________enclosed payable to ISPE in the amount o $ _________________ (i paying in US Dollars, check must be drawn on US Bank)

Subtract 50% o PUBLICATIONS

SHIPPING Based on subtotal pricing; see chart p. 29

Bill Credit Card - Circle Type:

VISA

MASTERCARD

AMEX

Caliornia, Florida, and North Carolina residents add state sales tax CA (7.25%), FL (7%), or NC (6.75%)

CARD EXP. NUMBER _______________________________________________________________________________________ DATE_________________________

Membership Fee (i elected)

NAME OF CARDHOLDER CARDHOLDE R _____________ ______________ _____________ ______________ _ SIGNATURE ____________ ______________ ______________ ___________

TOTAL

(AS IT APPEARS ON CARD)

**Allow 2-3 weeks or delivery. I you would like express delivery, please provide your UPS, DHL, or Federal Express account number and do not include shipping charges in your total.

ISPE does not pay customs or duties on international shipping. __________________________________________ _______________________________________________________ CARRIER

ACCOUNT NUMBER



27

ISPE Global Headquarters 600 N. Westshore Blvd., Suite 900 Tampa, Florida 33609 USA Tel: +1-813-960-2105 Fax: +1-813-264-2816 Email: [email protected]

www.ISPE.org/Publications

ISPE European Ofce

Avenue de Tervueren, 300 B-1150 Brussels, Belgium Tel: +32-2-743-4422 Fax: +32-2-743-1550 Email: [email protected] ISPE Asia Pacifc Ofce

20 Bendemeer Road #04-02/06, Cyberhub Singapore 339914 Tel: +65-6496-5500 Fax: +65-6496-5599 Email: asiapaci[email protected] ISPE China Ofce

Suite 2302, Wise Logic International Centre 66 North Shan Xi Road Shanghai, China 200041 Tel: +86-2-151-160265 Fax: +86-2-151-160260 Email: [email protected]

ISPE Publications Catalog

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