isp-124_pubs_jul-dec_2013_fnl_072213_single.pdf

The Col lect ive Knowledge of Global Industry and Regulatory Experts july – december 13

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the “How”�� “How To” practically implement approaches and principles defined in ISPE Guides

�� Applying defined principles and frameworks in specific circumstances

�� Typically technically based

�� May suggest specific solutions where several approaches or outcomes may be valid

ISPE Good Practice Guides give practical and technical details on how to apply principles and accepted overall frameworks effectively in specific circumstances. These principles and frameworks may be defined in other ISPE documents (e.g., Baseline® Guides or main GAMP® Guide). The Good Practice Guides would then show how to apply these in practice in different cases.

The Good Practice Guides may provide information or advice on a particular topic area, type of application or detailed technology. They may suggest specific solutions in an area where several approaches or outcomes may be valid.

Reflecting current regulatory expectations and good practices, the GAMP® series of Good Practice Guides provide interpretation of regulatory standards to help improve compliance, quality and efficiency while reducing cost.

Product Quality Lifecycle Implementation® (PQLI®) Good Practice Guides provide information on global solutions to implementation challenges of ICH guidance.

Guides

Good Practice Guides

the “What”�� Strategic in scope

�� Wide ranging implications

�� Define a framework for compliance in a particular area

�� New and/or innovative concept or subject matter

�� Areas of high compliance risk

�� High potential product quality and patient safety impact

�� High investment area

The Baseline® Guides are a series of industry guides developed in partnership with the US Food and Drug Administration (FDA). Each volume in the series is a collaborative effort of industry leaders representing a broad cross-section of manufacturers and other industry experts.

The Guides document current industry practice for facilities and systems used for production of pharmaceutical products. They establish a baseline approach to process and facility design, construction, specification and verification, based upon clear understanding of the product and process requirements. The Baseline® Guide principles also may be applied to existing facilities as they are upgraded or modernized.

The GAMP Guide provides pragmatic and practical industry guidance that aims to achieve compliant computerized systems that are fit for intended use in an efficient and effective manner, while also enabling innovation and technological advance.

Good PracticeGuide

Guide

Summer Sale! 20% Off all Guides now through 30 September 2013*

Use promo code 2013SUMMER when ordering to receive your discount.

ISPE, the International Society for Pharmaceutical Engineering, is the world’s largest not-for-profit association serving its Members through leading scientific, technical and regulatory advancement throughout the pharmaceutical lifecycle. The 20,000 Members of ISPE are building solutions in the development and manufacture of safe and effective pharmaceutical and biologic medicines and medical delivery devices in more than 90 countries around the world. ISPE Guidance Documents are produced by pharmaceutical manufacturing industry professionals and provide the practical, “real world” information you need to help your company build on current best practices to meet and exceed regulatory standards.

For full Guide descriptions, visit www.ISPE.org/Guidance-Documents

* May not be combined with any other discount or promotion. Discounts do not apply to the CPIP Study Guide, Mini-Regs, or the Medical Device Quality Systems Manual.

Inventory ClearanceBiopharmaceutical Manufacturing Facilities ....4Commissioning and Qualification

of Pharmaceutical Water and Steam Systems .........................................4

Sterile Product Manufacturing Facilities (Second Edition) ........................................5

Water and Steam Systems (Second Edition) ..5

Active Pharmaceutical IngredientsActive Pharmaceutical Ingredients, a Revision

of Bulk Pharmaceutical Chemicals .............6

BiotechnologyBiopharmaceutical Manufacturing Facilities ....6

CertificationCertified Pharmaceutical Industry

Professional (CPIP) Study Guide ................6

Commissioning and QualificationScience and Risk-Based Approach

for the Delivery of Facilities, Systems, and Equipment ..........................................7

Additional Commissioning and Qualification GuidesApplied Risk Management for

Commissioning and Qualification ...............7Commissioning and Qualification ...................7Commissioning and Qualification

of Pharmaceutical Water and Steam Systems .........................................7

ContainmentRisk-Based Manufacture of Pharmaceutical

Products (Risk-MaPP) ...............................8

Additional Containment GuidesActive Pharmaceutical Ingredients,

a Revision of Bulk Pharmaceutical Chemicals .................................................8

Assessing the Particulate Containment Performance of Pharmaceutical Equipment (Second Edition) ....................... 8

Critical UtilitiesOzone Sanitization of Pharmaceutical

Water Systems ..........................................9Process Gases ..............................................9

Additional Critical Utilities GuidesCommissioning and Qualification of

Pharmaceutical Water and Steam Systems .......................................10

Water and Steam Systems (Second Edition) ......................................10

FacilitiesQuality Laboratory Facilities ..........................10

Additional Facilities GuidesActive Pharmaceutical Ingredients,

a Revision of Bulk Pharmaceutical Chemicals ...............................................10

Biopharmaceutical Manufacturing Facilities ..10Commissioning and Qualification .................11Maintenance ................................................11Oral Solid Dosage Forms (Second Edition) ...11Risk-Based Manufacture of Pharmaceutical

Products (Risk-MaPP) .............................11Science and Risk-Based Approach

for the Delivery of Facilities, Systems, and Equipment ........................................11

Sterile Product Manufacturing Facilities (Second Edition) ......................................11

Water and Steam Systems (Second Edition) ......................................11

GAMP®

A Risk-Based Approach to Compliant GxP Computerized Systems ..........................12

GAMP® Good Practice GuidesA Risk-Based Approach to Calibration

Management (Second Edition) .................12A Risk-Based Approach to Compliant

Electronic Records and Signatures ..........12A Risk-Based Approach to GxP Compliant

Laboratory Computerized Systems (Second Edition) ....................................... 12

Additional GAMP® Good Practice GuidesA Risk-Based Approach to GxP Process

Control Systems (Second Edition) ...........13A Risk-Based Approach to Operation

of GxP Computerized Systems, A Companion Volume to GAMP® 5 ..........13

A Risk-Based Approach to Testing of GxP Systems (Second Edition) ................13

Electronic Data Archiving .............................13Global Information Systems Control and

Compliance .............................................13IT Infrastructure Control and Compliance .....14Manufacturing Execution Systems –

A Strategic and Program Management Approach ................................................14

Heating, Ventilation and Air Conditioning (HVAC)

Heating, Ventilation, and Air Conditioning (HVAC) ....................................................14

Investigational Products (IP)Comparator Management ............................14

Additional Investigational Products GuidesBooklet Labels .............................................15Comprehensive Guide to Clinical Materials ...15Development of Investigational Therapeutic

Biological Products..................................15Harmonizing the Definition and Use

of Non-Investigational Medicinal Products (NIMPs) ....................................15

Interactive Response Technology .................15Introductory US Clinical Trial Materials

Training Guide .........................................16Investigational Materials Sample

Retention Guide ......................................16

Oral Solid DosageOral Solid Dosage Forms (Second Edition) ...16

PackagingCold Chain Management .............................17Packaging, Labeling, and Warehousing

Facilities ..................................................17

Process Analytical Technology (PAT)

Change Management System as a Key Element of a Pharmaceutical Quality System ........................................18

Project Management (PM)Project Management for the

Pharmaceutical Industry ..........................19

Additional Project Management GuidesGood Engineering Practice ..........................19Maintenance ................................................19

Quality by Design (QbD)Process Performance and Product Quality

Monitoring System (PP&PQMS) – NEW ...20

Additional Quality by Design (QbD) GuidesChange Management System as a Key

Element of a Pharmaceutical Quality System ....................................................20

Product Realization using QbD, Concepts and Principles..........................20

Product Realization using QbD, Illustrative Example ..................................20

RegulatoryMini-Regulation Handbooks .........................21Medical Device Quality Systems Manual ......21

SterileSterile Product Manufacturing Facilities

(Second Edition) ......................................22

Guidance Document Translations Available

Chinese .......................................................22French .........................................................22German .......................................................22Japanese .....................................................23

To order: Go to www.ISPE.org/Store

To order, visit www.ISPE.org/Store. 5

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Biopharmaceutical Manufacturing FacilitiesThe Biopharmaceutical Manufacturing Facilities Baseline® Guide explores products and facilities that house biotechnological processes and specifically applies to process design ties to facility design, controlled processing, preventing contamination, and segregation and flow. The Guide is a reference for design, construction, commissioning and qualification of new facilities for biopharmaceutical Active Pharmaceutical Ingredients (APIs), also known as drug substance. The Guide covers in-line process analytical measurement and control, the use of disposable equipment, enhanced strategies for automation and alternative methods for protecting the integrity of the product. The Guide addresses US GMPs, while the GMPs of other countries and regions are covered in the appendices.

Bound Item #: BIO0604Bound Pricing:Member $200/€155 $100/€77.50New Member* $469/€374 $234.50/€187Nonmember $495/€395 $247.50/€197.50

Bound/CD Set Item #: BIOELEC Bound/CD Set Pricing:Member $340/€265New Member $609/€484Non-Member $640/€510

Individual PDF Download Item #: BIO0604DLPDF Download Pricing:Member $200/€155New Member* $469/€374Nonmember $495/€395

Commissioning and Qualification of Pharmaceutical Water and Steam SystemsThe Commissioning and Qualification of Pharmaceutical Water and Steam Systems Guide provides an alternative approach, based on “risk assessment” principles and “process understanding” for the commissioning and qualification of direct impact water and steam systems. This Guide will show you how to change your focus from a “qualify everything” approach, to a more efficient and cost-effective risk-based evaluation of individual system components or process steps. The Guide, intended as a supplement to the ISPE Baseline® Guide on Commissioning and Qualification, aims to apply the principles discussed in the ISPE Baseline® Guide to direct water and steam systems.

Bound Item #: IGPGCQWSBound Pricing:Member $145/€115 $72.50/€57.50New Member* $414/€334 $207/€167Nonmember $435/€355 $217.50/€177.50

Individual PDF Download Item #: IGPGCQWSDLPDF Download Pricing: Member $145/€115New Member* $414/€334Nonmember $435/€355

Inventory

Publication date: July 2004Pages: 196

Publication date: February 2007Pages: 88

* New Member fee includes one-year membership in ISPE – a $269/€219 value. See order form for details. 5

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Inventory

Publication date: December 2011Pages: 264

Publication date: September 2011Pages: 204

ClearanceSterile Product Manufacturing Facilities (Second Edition)The Sterile Product Manufacturing Facilities Baseline Guide addresses the design, construction, commissioning, and qualification of facilities designed for aseptic processing of formulated products. The Guide is designed for use by industry for the design, construction, commissioning, and qualification of new or renovated aseptic/sterile manufacturing facilities. Updated in 2011, the Guide contains recommendations to help facilitate compliance with the latest FDA and EMA guidance and incorporates a comprehensive tabulation, explanation and comparison of the cleanliness designations found in FDA, EMA and ISO guidance documents, allowing for better harmonization in global facility design and a wider breadth of regulatory compliance internationally. The Guide consolidates all of ISPE’s latest best practice recommendations on sterile manufacturing facility design into one document.

Bound Item #: STER0911Bound Pricing:Member $200/€155 $100/€77.50New Member* $469/€374 $234.50/€187Nonmember $495/€395 $247.50/€197.50

Individual PDF Download Item #: STER0911DL

PDF Download Pricing:Member $200/€155New Member* $469/€374Nonmember $495/€395

Water and Steam Systems (Second Edition)The Water and Steam Systems Baseline Guide is the only comprehensive guidance of its kind that aims to assist with the design, construction, operation and maintenance of new water and steam systems that meet cGMPs and comply with existing regulations and related guidance. New chapters covering microbiological considerations, such as biofilm formation, use of sanitizers, sampling, testing and control levels, as well as the overall impact of microbial considerations on unit operations and finished water have been added. The Guide was written by a global team of critical utilities experts with a combined experience of more than 500 years. Much of the team responsible for the original Water and Steam Systems Baseline Guide has returned to contribute to the revised Guide, providing continuity and longevity of vision to the Guide’s contents.

Bound Item #: WAT1211

Bound Pricing:Member $200/€155 $100/€77.50New Member* $469/€374 $234.50/€187Nonmember $495/€395 $247.50/€197.50

Individual PDF Download Item #: WAT1211DL



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Active Pharmaceutical Ingredients

Active Pharmaceutical Ingredients, a Revision of Bulk Pharmaceutical ChemicalsThis revised Baseline® Guide builds on the original principles of 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 for Industry, Sterile Drug Products Produced by Aseptic Processing – Current Good Manufacturing Practice (cGMP), FDA Draft Guidance for Industry PAT – Framework for Innovative Pharmaceutical Manufacturing and Quality Assurance and much more.

BONUS White Paper: With purchase of API, you will receive the white paper, “A Risk-Based Approach to Defining Levels of Protection within API Facility Design: The Concept of Briefly Exposed (Briefly Open),” by Stan Newberger and Dr. Trish Melton. This white paper expands and clarifies a new concept introduced in the Guide.

Bound Item #: API0607

Individual PDF Download Item #: API0607DL

Bound or PDF Download Pricing:Member $200/€155New Member* $469/€374Nonmember $495/€395

Publication date: June 2007Pages: 188

Biotechnology

Biopharmaceutical Manufacturing FacilitiesSee page 4 for description and special pricing (on bound version only).

Bound Item #: BIO0604

Individual PDF Download Item #: BIO0604DLPublication date: July 2004 Pages: 196

Bound/CD SetItem #: BIOELEC

Certified Pharmaceutical Industry Professional (CPIP) Study GuideThe electronic Study Guide provides a detailed description of knowledge elements to be included in the CPIP certification program examination. This Document contains references in the public domain, which can be used to prepare for the examination and/or as an everyday work Reference tool.

Individual PDF Download Item #: CPIPSTUDY5DLPublication date: May 2012 Pages: 32

PDF Download Pricing:Member $40/€32Nonmember $60/€48

†Emerging Economy Discount is not available on this item.

Certification


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Commissioning and Qualification

Science and Risk-Based Approach for the Delivery of Facilities, Systems, and EquipmentThe successful delivery of manufacturing facilities regulated by various authorities, poses significant challenges to manufacturers, engineering professionals 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 of a science- and risk-based approach for demonstrating that pharmaceutical and biopharmaceutical facilities, systems, equipment and associated automation are fit for intended use and comply with regulatory requirements.

The aim of the Guide is to facilitate the translation of the scientific knowledge about the product and process into documented specification, design and verification of facilities, systems and equipment. Specific implementation guidance is given on meeting the expectations of 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



Additional Commissioning and Qualification Guides

Applied Risk Management for Commissioning and QualificationIllustrates the application of quality risk management to traditional C&Q practices, linking traditional terminology and approaches to the newer science- and risk-based approaches applied in ICH Q8, Q9 and Q10 and ASTM E2500.

Bound Item #: IGPGARMCQ

Individual PDF Download Item #: IGPGARMCQDLPublication date: October 2011Pages: 140


Commissioning and QualificationFocuses on engineering approaches and practices for timely, cost-effective designing, constructing, commissioning and qualifying manufacturing facilities, utilities and equipment.

Bound Item #: CQ0101

Individual PDF Download Item #: CQ0101DLPublication date: March 2001Pages: 142


Bound/CD Item #: CQELECBound/CD Set Pricing:Member $340/€265New Member* $609/€484Nonmember $640/€510

Commissioning and Qualification of Pharmaceutical Water and Steam SystemsSee page 4 for description and special pricing (on bound version only).

Bound Item #: IGPGCQWS

Individual PDF Download Item #: IGPGCQWSDLPublication date: February 2007Pages: 88


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Containment

Risk-Based Manufacture of Pharmaceutical Products (Risk-MaPP)The ISPE Baseline® Guide: Risk-Based Manufacture of Pharmaceutical Products (Risk-MaPP) provides a scientific risk-based approach based on ICH Q9 to manage the risk of cross-contamination to maintain product quality and operator safety. This allows the selection of the appropriate risk control strategies to be implemented on a case-by-case basis to maintain patient safety and assure product quality.

This Guide provides a process that allows manufacturers to assess risk and determine where control strategies are necessary to meet acceptable limits for cross-contamination. The control strategies to manage risk can vary from administrative to full dedication or segregation. Typically, some combination of control strategies may be necessary.

This Risk-MaPP Guide is intended to provide professionals in the pharmaceutical industry with a consistent approach on setting acceptable limits to assess the potential of cross-contamination causing an undue risk to patient safety. This approach is intended to allow manufacturers to contain manufacturing cost while facilitating safe and affordable drug product. This Guide should be used in conjunction with local and/or applicable (multi-national manufacturing platforms) regulatory requirements and other guidance documents already available to the pharmaceutical manufacturing industry.

Bound Item #: RISK0910

Individual PDF Download Item #: RISK0910DL



Active Pharmaceutical Ingredients, a Revision of Bulk Pharmaceutical ChemicalsProvides guidance on design, construction, commissioning, qualification and validation of Active Pharmaceutical Ingredients (APIs) facilities, bulk pharmaceutical chemicals, intermediates and non-APIs (excipients) facilities.


Individual PDF Download Item #: API0607DL Publication date: June 2007Pages: 188


Assessing the Particulate Containment Performance of Pharmaceutical Equipment (Second Edition)Provides technical guidance and consistent methodologies for evaluating the particulate containment performance of pharmaceutical equipment and systems.

Bound Item #: IGPGAPC2

Individual PDF Download Item #: IGPGAPC2DLPublication date: May 2012Pages: 104


Additional Containment Guides


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Critical Utilities

Ozone Sanitization of Pharmaceutical Water SystemsThe ISPE Good Practice Guide: Ozone Sanitization of Pharmaceutical Water Systems provides important insight into the design and use of pharmaceutical ozone sanitization systems, and is the first industry Guidance Document to take a holistic view of these issues. The Guide provides an overview of ozone sanitization systems, including regulatory considerations and other factors companies should take into account when deciding to use ozone vs. other sanitization approaches. It discusses specific system requirements, as well as associated advantages and disadvantages of using ozone as a water sanitization method.

The Guide helps companies better understand what ozone systems are, why they can be a safer, more efficient and more cost-effective way to sanitize pharmaceutical water and how they can be incorporated into both new and retrofitted facilities.

Bound Item #: IGPGOZONE

Individual PDF Download Item #: IGPGOZONEDL


Process Gases The ISPE Good Practice Guide: Process Gases aims to define current good practices within pharmaceutical manufacturing applications, providing information to allow organizations to benchmark their practices and improve upon them.

The Guide focuses on defining cost-effective engineering approaches and practices used to deliver a process gas system for a manufacturing facility in a timely manner that will meet its intended purpose. Information is provided on how to avoid increasing facility installation and operational costs.

Specifically, the Guide addresses the process of designing, constructing, commissioning and qualifying 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 clarify gas system issues critical to product quality for the production of biopharmaceutical and pharmaceutical drug substances and drug products.

The Guide promotes science and risk-based approaches to provide an effective basis for the planning, construction, commissioning and qualification processes for gas systems used to support production.

Bound Item #: IGPGPGAS

Individual PDF Download Item #: IGPGPGASDL





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* New Member fee includes one-year membership in ISPE – a $269/€219 value. See order form for details.

Additional Critical Utilities Guides

Commissioning and Qualification of Pharmaceutical Water and Steam SystemsSee page 4 for description and special pricing (on bound version only).

Bound Item #: IGPGCQWS

Individual PDF Download Item #: IGPGCQWSDL Publication date: February 2007Pages: 88

Water and Steam Systems (Second Edition)See page 5 for description and special pricing (on bound version only).


Individual PDF Download Item #: WAT1211DL Publication date: December 2011Pages: 264

Facilities

Quality Laboratory FacilitiesISPE has produced the industry’s first Guidance Document to establish a baseline for the design of Quality Laboratory Facilities. The ISPE Good Practice Guide: Quality Laboratory Facilities is a comprehensive guide to defining design guidelines for Quality Laboratories supporting GxP-regulated facilities producing pharmaceutical products for human and animal applications. It provides a step-by-step process that guides the reader through all phases of producing a quality lab and all the factors that must be considered at each phase. The Guide helps save time and money by facilitating effective communication between lab owners, engineers and builders about the function, operation and design parameters that must be met.

Bound Item #: IGPGQLF

Individual PDF Download Item #: IGPGQLFDL



Additional Facilities Guides

Active Pharmaceutical Ingredients, a Revision of Bulk Pharmaceutical ChemicalsProvides guidance on design, construction, commissioning, qualification and validation of Active Pharmaceutical Ingredients (APIs) facilities, bulk pharmaceutical chemicals, intermediates and non-APIs (excipients) facilities.


Individual PDF Download Item #: API0607DL Publication date: June 2007Pages: 188


Biopharmaceutical Manufacturing FacilitiesSee page 4 for description and special pricing (on bound version only).

Bound Item #: BIO0604

Individual PDF Download Item #: BIO0604DL Publication date: July 2004Pages: 196

Bound/CD Set Item #: BIOELEC

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Commissioning and QualificationSee page 7 for description.

Bound Item #: CQ0101

Individual PDF Download Item #: CQ0101DL Publication date: March 2001Pages: 142


Bound/CD Set Pricing:Item #: CQELECMember $340/€265New Member* $609/€484Nonmember $640/€510

MaintenanceProvides practical solutions and tools for ensuring technical and regulatory accuracy and cost-effective compliance in a new or existing maintenance program.

Bound Item #: IGPGMAINT

Individual PDF Download Item #: IGPGMAINTDL Publication date: May 2009Pages: 108


Oral Solid Dosage Forms (Second Edition)Addresses the latest interpretation of GMP requirements, as well as a risk-based approach to regulatory compliance relating to the design, construction and validation of OSD manufacturing facilities.

Bound Item #: OSD1109

Individual PDF Download Item #: OSD1109DL Publication date: November 2009Pages: 188


Risk-Based Manufacture of Pharmaceutical Products (Risk-MaPP)See page 8 for description.

Bound Item #: RISK0910

Individual PDF Download Item #: RISK0910DL Publication date: September 2010Pages: 152


Science and Risk-Based Approach for the Delivery of Facilities, Systems, and EquipmentSee page 7 for description.

Bound Item #: IGFSE

Individual PDF Download Item #: IGFSEDL Publication date: June 2011Pages: 120


Sterile Product Manufacturing Facilities (Second Edition)See page 5 for description and special pricing (on bound version only).

Bound Item #: STER0911

Individual PDF Download Item #: STER0911DL Publication date: September 2011Pages: 204

Water and Steam Systems (Second Edition)See page 5 for description and special pricing (on bound version only).


Individual PDF Download Item #: WAT1211DL Publication date: December 2011Pages: 264

Additional Facilities Guides continued


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GAMP®

A Risk-Based Approach to Compliant GxP Computerized Systems 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 fit for intended use in an efficient and effective manner, while also enabling innovation and technological advance. The revised Guide describes a flexible risk-based approach to compliant GxP regulated computerized systems, based on scalable specification and verification. A robust quality risk management process based on ICH Q9 principles is central to the approach. GAMP® 5 also contains new information on outsourcing, electronic batch recording, end user applications (such as spreadsheets and small database applications) and patch management.

CD accompanying the Guide provides supporting materials, including differences between GAMP® 4 and GAMP® 5, key diagrams, templates, forms, example documents and background information. (CD is Windows compatible only.)

Bound Item #: 5BOUND

Individual PDF Download Item #: 5BOUNDDL


Publication date: February 2008Pages: 356

A Risk-Based Approach to Calibration Management (Second Edition)Provides guidance in setting up a calibration management system to give a structured approach to instrument risk assessment, calibration program management, documentation and corrective actions essential to regulatory compliance.

Bound Item #: GGPGCALMGMT2

Individual PDF Download Item #: GGPGCALMGT2DL Publication date: November 2010Pages: 124


A Risk-Based Approach to Compliant Electronic Records and SignaturesPresents a comprehensive approach for compliant electronic records and signatures, emphasizing well-documented, validated systems and the application of appropriate operational controls.

Bound Item #: 4ERS

Individual PDF Download Item #: 4ERSDL Publication date: February 2005Pages: 240


A Risk-Based Approach to GxP Compliant Laboratory Computerized Systems (Second Edition)Contains practical, risk-based approach that those involved in managing laboratory computerized system acquisition, implementation and operations can use to verify laboratory systems are fit for their intended use.

Bound Item #: GGPGLABCS2

Individual PDF Download Item #: GGPGLABCS2DL Publication date: October 2012Pages: 160


GAMP® Good Practice Guides


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A Risk-Based Approach to GxP Process Control Systems (Second Edition)Describes the system lifecycle from concept to retirement, providing a high-level overview of the approach and guidance on how activities might be scaled based on risk to product quality, system novelty and complexity.

Bound Item #: GGPGPCS2

Individual PDF Download Item #: GGPGPCS2DL Publication date: February 2011Pages: 196


A Risk-Based Approach to Operation of GxP Computerized Systems, A Companion Volume to GAMP® 5Helps organizations achieve compliant computerized systems that are fit for intended use, with comprehensive guidance for maintaining control of regulated systems throughout their operational life.

Bound Item #: GGPGOGCS

Individual PDF Download Item #: GGPGOGCSDL Publication date: January 2010Pages: 216


A Risk-Based Approach to Testing of GxP Systems (Second Edition)Helps maximize testing efficiency without compromising the quality of GxP systems by focusing testing on areas that have the greatest impact and eliminating duplicate testing, with updated information on cloud computing, automated testing and non-linear development.

Bound Item #: GGPGTEST2

Individual PDF Download Item #: GGPGTEST2DL Publication date: December 2012Pages: 276


Electronic Data ArchivingProvides a rational and scaleable approach to electronic data archiving to help organizations achieve and maintain regulatory compliance and effectively manage electronic records.

Bound Item #: 4EDA

Individual PDF Download Item #: 4EDADL Publication date: July 2007Pages: 152


Global Information Systems Control and ComplianceProvides an understanding of the issues faced by teams that are tasked with completing a global deployment of an IT system, including control and regulatory compliance issues.

Bound Item #: 4GIS

Individual PDF Download Item #: 4GISDL Publication date: November 2005Pages: 96


Additional GAMP® Good Practice Guides


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Heating, Ventilation and Air Conditioning (HVAC)

Investigational Products (IP)

Heating, Ventilation, and Air Conditioning (HVAC)HVAC systems can be critical systems that affect the ability of a pharmaceutical facility to meet its objective of providing safe and effective 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 functional design that define the facility’s objectives. It also provides options to be considered in creating a design that has low lifecycle cost and that is sustainable.

Bound Item #: IGPGHVAC

Individual PDF Download Item #: IGPGHVACDL


Comparator ManagementThe ISPE Good Practice Guide: Comparator Management is the pharmaceutical industry’s first-ever resource for comparator processes. It has been developed to use as a central reference source that establishes strategic and tactical considerations related to comparator sourcing. It identifies good practices for making sourcing decisions, including how to set up a good sourcing team. The Guide also discusses good practices for blinding and releasing a comparator for use.

The Guide will also explain the risks involved with ineffective comparator methods, and provide companies with strategies for avoiding the costs, delays and potential case study inaccuracies that might result from faulty comparator management.

Bound Item #: IGPGCMGMT

Individual PDF Download Item #: IGPGCMGMTDL



Publication date: March 2012Pages: 84

IT Infrastructure Control and ComplianceProvides comprehensive guidance for compliant IT Infrastructure platforms, including the need to identify, qualify and control those aspects impacted by GxP.

Bound Item #: 4IT

Individual PDF Download Item #: 4ITDL Publication date: September 2005Pages: 128


Manufacturing Execution Systems – A Strategic and Program Management ApproachPresents a complete lifecycle approach to the development and use of MES for regulated manufacturing as a collection or domain of manufacturing-related functions that integrates business and process controls, information flow and human interaction.

Bound Item #: GGPGMES

Individual PDF Download Item #: GGPGMESDL Publication date: February 2010Pages: 144


Additional GAMP® Good Practice Guides continued


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Additional Investigational Products Guides

Booklet LabelsProvides suggestions for effective and compliant booklet label design; includes recommendations and justification for placement of required information.

Individual PDF Download Item #: IGPGBKLBDL Publication date: March 2013Pages: 42


Comprehensive Guide to Clinical MaterialsA Handbook for Training Clinical Materials ProfessionalsProvides tools for the development of in-house training sessions for advanced training, building on the topics covered in the Introductory US Clinical Trial Materials Training Guide.

Bound Item #: CMHB2006

Individual PDF Download Item #: CMHB2006DL Publication date: July 2006Pages: 120


Development of Investigational Therapeutic Biological ProductsDiscusses the major issues confronting a biopharmaceutical company in moving therapeutic biological products from the laboratory to the clinic and beyond.

Bound Item #: IGPGBIOL

Individual PDF Download Item #: IGPGBIOLDL Publication date: August 2007Pages: 92


Harmonizing the Definition and Use of Non-Investigational Medicinal Products (NIMPs)Provides practical operational guidance to encourage a consistent industry approach for the use of NIMPs, including criteria for classifying NIMPs and an overview of current regulatory requirements.

Individual PDF Download Item #: IGPGNIMPSDL Publication date: January 2013Pages: 56


Interactive Response TechnologyDescribes how the pharmaceutical industry can apply interactive response technology to support various clinical trial activities, including expiry date management and program pooling.

Individual PDF Download Item #: IGPGIRTDL Publication date: November 2011Pages: 92



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Oral Solid Dosage

Oral Solid Dosage Forms (Second Edition)This revision updates content from the original Oral Solid Dosage Forms Baseline® Guide to current industry standards, practices and regulatory requirements.

Specifically, it addresses the latest interpretation of GMP requirements, as well as a risk-based approach to regulatory compliance relating to the design, construction and validation of the OSD manufacturing facility. The product and processing chapter has been expanded with detailed discussion of each critical unit operation and new technological trends, such as continuous processing and implementation of process analytical technology. The Guide provides a comprehensive view of best practices available in the pharmaceutical industry for oral solid manufacturing facility design and construction. A lifecycle approach to project management is emphasized.

Bound Item #: OSD1109

Individual PDF Download Item #: OSD1109DL


Publication date: November 2009Pages: 188

Introductory US Clinical Trial Materials Training GuideDesigned to familiarize new clinical trial materials professionals operating under the rules of the US FDA with the terms and related information they need for success.

Bound Item #: CMGUIDEPublication date: October 2002Pages: 44

Bound Pricing:Member $15/€12Nonmember $25/€20

Investigational Materials Sample Retention GuideSupplement to the Introductory US Clinical Trial Materials Training Guide; assists users in determining quantity and retention time for sample products.

Bound Item #: CMRETGDPublication date: July 2003


Additional Investigational Products Guides continued


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Packaging

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

This Guide provides tools and strategies for Cold Chain Management and to complement work by the Guidance for Temperature Controlled Medicinal Products. It helps to develop, establish, document, implement, maintain and improve industry good practice for product requiring controlled cold conditions. The Guide is intended to provide practical guidance to assist in the specification, design, commissioning and verification of the fixed and passive systems within the cold chain.

The Guide is intended to provide a robust, cost-effective system to ensure a safe, effective product is received by the end users. The Guide covers the process from the point of entry into the manufacturers’ controlled temperature storage facility after being packaged through delivery to the distributor or customer premises.

Bound Item #: IGPGCCM

Individual PDF Download Item #: IGPGCCMDL


Packaging, Labeling, and Warehousing FacilitiesThe ISPE Good Practice Guide: Packaging, Labeling, and Warehousing Facilities is the industry’s only guidance relating to the design, construction and commissioning and qualification of packaging, labeling and warehousing (PACLAW) facilities. The Guide helps companies meet CGMP requirements for these types of facilities 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 efficient, compare their processes to established best practices and demonstrate compliance to regulatory agencies.

This Guide presents an approach to satisfying 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 reconfiguration of PACLAW facilities. It covers facility design issues for most primary packaging operations, such as filling of the dosage form 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 risk-based inspectional model as it relates to PACLAW facilities.

Bound Item #: IGPGPACLAW

Individual PDF Download Item #: IGPGPACLAWDL


Publication date: May 2011Pages: 140



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Process Analytical Technology (PAT)

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

The PQLI Guide on Change Management outlines potential product lifecycle approaches to the change management system of 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 first two PQLI Guides as part of a larger Quality by Design approach, or as a stand-alone change management manual.

Individual PDF Download Item #: PQLI3DL



Don’t Miss these Upcoming Conferences!

Biotechnology27 – 28 August 2013 • Durham, North Carolina USA

Discover how experts will develop and validate projects using next-generation manufacturing systems, advances in bioprocessing and streamlined compliance programs.

Visit www.ISPE.org/2013BiotechConference to register

Proactive Compliance7 – 8 October 2013 • New Brunswick, New Jersey USA

Be proactive, not reactive! Acquire “Best in Class” tools and strategies to transform your company’s approach to compliance.

Visit www.ISPE.org/2013ProactiveComplianceConference to register

Process Validation Conference9 – 10 October 2013 • New Brunswick, New Jersey USA

New expectations are bringing about significant changes in Process Validation approaches. Understand how these expectations can be transformed into practical actions and business processes.

Visit www.ISPE.org/2013ProcessValidationConference to register

ISPE Annual Meeting: Quality Throughout the Product Lifecycle3 – 6 November 2013 • Washington, DC USA

Packed with educational content to address all experience levels and job functions, the Annual Meeting brings together influential industry and regulatory experts to provide you with the latest in innovative processes, technologies and quality management techniques.

Visit www.ISPE.org/2013AnnualMeeting to register


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Project Management (PM)

Project Management for the Pharmaceutical IndustryThe ISPE Good Practice Guide: Project Management for the Pharmaceutical Industry provides good practice approaches which promote the successful integration of GxP with relevant project management activities to ensure that compliance risk is managed effectively and proactively.

The Guide discusses: the tools and techniques supporting project delivery, the life cycle of a typical project in the pharmaceutical industry and how compliance to pharmaceutical industry regulations is integrated with the project lifecycle.

Bound Item #: IGPGPM

Individual PDF Download Item #: IGPGPMDL


Publication date: November 2011Pages: 282

Additional Project Management Guides

Good Engineering PracticeProvides proven and accepted engineering methods, procedures and practices that provide appropriate, cost-effective and well-documented solutions to meet user requirements and regulatory compliance.

Bound Item #: IGPGGEP

Individual PDF Download Item #: IGPGGEPDL Publication date: December 2008Pages: 196


MaintenanceProvides practical solutions and tools for ensuring technical and regulatory accuracy and cost-effective compliance in a new or existing maintenance program.

Bound Item #: IGPGMAINT

Individual PDF Download Item #: IGPGMAINTDL Publication date: May 2009Pages: 108



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Quality by Design (QbD)

Change Management System as a Key Element of a Pharmaceutical Quality SystemSee page 18 for description.

Individual PDF Download Item #: PQLI3DL Publication date: June 2012Pages: 56


Product Realization using QbD, Concepts and PrinciplesProduct Quality Lifecycle Implementation® (PQLI®) from Concept to Continual Improvement Part 1 includes the topics of Criticality, Design Space and Control Strategy and addresses product and process development, transfer to and establishment of, commercial manufacture using science- and risk-based approaches.

Bound Item #: PQLI1

Individual PDF Download Item #: PQLI1DL Publication date: November 2011Pages: 188


Product Realization using QbD, Illustrative ExampleProduct Quality Lifecycle Implementation (PQLI®) from Concept to Continual Improvement Part 2 presents the small molecule case study detailing of the application of the approaches to product and process understanding using quality risk management.

Bound Item #: PQLI2Individual PDF Download Item #: PQLI2DL Publication date: November 2011Pages: 232


Additional Quality by Design (QbD) Guides

Process Performance and Product Quality Monitoring System (PP&PQMS) – NEWThe ISPE PQLI® Guide: Part 4 – Process Performance and Product Quality Monitoring System serves as practical how-to guidance with examples of technical and scientific methodology for adopting a process performance and product quality monitoring system (PP&PQMS) in line with the expectations of ICH Q10, Pharmaceutical Quality System.

By establishing a PP&PQMS, your company can improve opportunities to maintain compliance with global regulations and improve confidence that a process runs as intended.

The Guide introduces the role of Quality Steward as an owner of product quality. Responsibilities of the role are discussed for this new concept emerging from industry.

This PQLI Guide is relevant for new and existing products, small and large molecule and all phases of product lifecycle, from development through product discontinuation.

Individual PDF Download Item #: PQLI4DL




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Regulatory

21 CFR Part 4 – Combination Products This guidance issued by the FDA outlines the CGMP requirements applicable to combination products. Item #: GMP051 Pricing: $5/€4

21 CFR Part 11 – Electronic RecordsThis guidance issued by the FDA defines the criteria under which electronic records and electronic signatures are considered trustworthy, reliable and equivalent to paper records.Item #: GMP044 Pricing: $5/€4

21 CFR Part 111 – Dietary SupplementsThis guidance issued by the FDA defines the criteria for CGMP in manufacturing, packaging, labeling or holding operations for Dietary Supplements.Item #: GMP049 Pricing: $5/€4

21 CFR Part 820 – Medical DevicesThis guidance issued by the FDA governs the methods used in, and the facilities and controls used for, the design, manufacture, packaging, labeling, storage, installation and servicing of all finished devices intended for human use. Item #: GMP036 Pricing: $5/€4

21 CFR Parts 210 and 211 – Manufacturing, Processing, Packing, or Holding of Drugs; General and Current Good Manufacturing Practice for Finished PharmaceuticalsThis guidance issued by the FDA contains the minimum CGMP for methods to be used to assure the drug meets the requirements of safety, has the identity and strength and meets the quality and purity standards it is represented to possess.Item #: GMP035 Pricing: $5/€4

ICH Q7A – Active Pharmaceutical IngredientsThis guidance represents the FDA’s current thinking regarding GMPs for manufacturing APIs under an appropriate system for managing quality as developed by ICH. It is also intended to help ensure that APIs meet the quality and purity characteristics that they purport, or are represented, to possess.Item #: GMP045 Pricing: $5/€4

ICH Q8 (R2) – Pharmaceutical DevelopmentThe Q8 parent guidance describes the suggested contents for the Pharmaceutical Development section of a regulatory submission in the ICH M4 Common Technical Document format.Item #: GMP048 Pricing: $5/€4

ICH Q9 – Quality Risk ManagementThis ICH guidance offers a systematic approach to quality risk management, specifically, guidance on the principles and some tools of quality risk management that can enable more effective and consistent risk-based decisions.Item #: GMP046 Pricing: $5/€4

ICH Q10 – Quality SystemsThis ICH guidance assists manufacturers by describing a model for an effective quality management system for the pharmaceutical industry, referred to as the pharmaceutical quality system. Throughout this guidance, the term pharmaceutical quality system refers to the ICH Q10 model.Item #: GMP047 Pricing: $5/€4

ICH Q11 – Development and Manufacture of Drug SubstancesThis ICH guidance describes approaches to developing and understanding the manufacturing process of the drug substance including both chemical entities and biotechnological/biological entities.Item #: GMP050 Pricing: $5/€4

Medical Device Quality Systems ManualThis manual covers requirements of the Quality System regulation that manufacturers of medical devices must consider when they design devices, or when they manufacture, contract manufacture, remanufacture, process, repack or relabel finished medical devices intended to be commercially distributed. It also contains model procedures and sample forms. This is a must-have for every medical device manufacturing plant!

Bound Item#: GMP039Publication date: December 1996Pages: 300+


Mini-Regulation HandbooksThese handy pocket-size booklets are an ideal way to keep everyone informed of US FDA and ICH regulations and guidelines.


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Chinese• Baseline® Guide: Oral Solid Dosage Forms (Second Edition)

• Baseline® Guide: Sterile Product Manufacturing Facilities (Second Edition)

• GAMP® 5: A Risk-Based Approach to Compliant GxP Computerized Systems (Fifth Edition)

To purchase, visit www.ISPE.org/Guidance-Documents.

French• GAMP® 5: A Risk-Based Approach to Compliant GxP Computerized Systems (Fifth Edition)

To purchase, visit www.ISPE.org/Guidance-Documents.

German• GAMP® 5: A Risk-Based Approach to Compliant GxP Computerized Systems (Fifth Edition) – also available as electronic

• GAMP® Good Practice Guide: A Risk-Based Approach to Operation of GxP Computerized Systems (OGCS) (First Edition)

• GAMP® Good Practice Guide: A Risk-Based Approach to Testing of GxP Systems (Second Edition) – available as electronic only

To purchase, visit www.ISPE.org/Store.

Translated Guidance Documents are available in printed bound format unless otherwise noted.

Sterile

Sterile Product Manufacturing Facilities (Second Edition)See page 5 for description and special pricing (on bound version only).

Bound Item #: STER0911

Individual PDF Download Item #: STER0911DL Publication date: September 2011Pages: 204

Guidance Document Translations Available


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Additional Guidance Document Translations Available

Japanese

Baseline® Guides

• Active Pharmaceutical Ingredients (Second Edition)

• Biopharmaceutical Manufacturing Facilities (First Edition)

• Commissioning and Qualification (First Edition)

• Oral Solid Dosage Forms (Second Edition)

• Risk-Based Manufacture of Pharmaceutical Products (Risk-MaPP) (First Edition)

• Sterile Product Manufacturing Facilities (Second Edition)

ISPE Good Practice Guides

• Assessing the Particulate Containment Performance of Pharmaceutical Equipment (Second Edition)

• Commissioning and Qualification of Pharmaceutical Water and Steam Systems (First Edition)

• Good Engineering Practice (GEP) (First Edition)

• Maintenance (First Edition)

GAMP®/GAMP® Good Practice Guides

• GAMP® 5: A Risk-Based Approach to Compliant GxP Computerized Systems (Fifth Edition)

• A Risk-Based Approach to Compliant Electronic Records and Signatures (ER&S) (First Edition)

• A Risk-Based Approach to GxP Process Control Systems (GPCS) (Second Edition)

• A Risk-Based Approach to Operation of GxP Computerized Systems (OGCS) (First Edition)

• IT Infrastructure Control and Compliance (First Edition)

• Manufacturing Execution Systems – A Strategic and Program Management Approach (MES) (First Edition) – available as electronic only

• Validation of Laboratory Computerized Systems (First Edition)

Investigational Products Publications

• Comprehensive Guide to Clinical Materials – A Handbook for Training CM Professionals (First Edition)

ISPE PQLI® Guide Series

• Part 1 – Product Realization using Quality by Design (QbD): Concepts and Principles, including Overview, Criticality, Design Space, and Control Strategy (First Edition)

• Part 2 – Product Realization using Quality by Design (QbD): Illustrative Example (First Edition)

To purchase, contact the Japan Affiliate at www.ISPE.org.gr.jp.


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Membershiphas its benefits

ISPe has something for you!ISPE, is the world’s largest not-for-profit association dedicated to preparing technical professionals to lead global change and innovation in pharmaceutical manufacturing sciences and technology. Members enjoy significant discounts on ISPE Guidance Documents, Conference Registrations, Training and Online Learning, and much more.

• ISPE includes a membership rich with diversity and offering a broad representation of all pharmaceutical professionals.

• We work to keep our membership informed of the latest technological and regulatory trends occurring in the pharmaceutical marketplace.

• We are committed to the advancement of the educational and technical efficiency of our Members through forums for the exchange of ideas and practical experience.

Start your journeyRegardless of where you are in your career, ISPE provides critical and timely opportunities for you to update your skills, learn about new technologies and advancements, and collaborate with industry leaders.

Visit www.ISPE.org/MembershipLearn more about how joining ISPE can help give you a competitive edge.


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3 easy ways to orderComplete and return the order form in this catalog. Indicate payment amount in either US dollars ($) or Euros (€). You may also purchase publications online at www.ISPE.org. All address and contact information must be provided on the order form, including shipping address, contact person and telephone number. Please provide a street address for shipping purposes. We cannot deliver to a PO box. We must receive payment before an order can be shipped. Incomplete forms will delay shipping. Member discounted orders must be shipped to the Member. No drop shipments.Members in Emerging Economy Countries receive 50 percent off original single copy price. Fifty percent off does not apply to shipping charges. Visit www.ISPE.org/emergingeconomylist for eligible countries.

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Advance your career, enhance your credibility and earn industry-wide recognition with Certified Pharmaceutical Industry Professional (CPIP) Certification.

“CPIP certification stands as a shining cornerstone in my pharmaceutical career. The pharmaceutical industry is a continuously changing environment; therefore, it motivates us to continue to grow and learn right alongside it to ensure patients come first in all we do.” Dawn E. Contreras, CPIP, Project Engineer, Barry-Wehmiller Design Group

Want a list of eligibility requirements? Need to find or start a study group? The ISPe Professional certification commission provides support throughout the process.

learn more; visit www.ISPe-Pcc.org today!®

Follow the cPIP Path to Success

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Submit your eligibility application.

Prepare for the exam.

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see page 6 for details

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