Ord an er (S d R by om e 3 e ce 0 S Re i st ve ep ric 2 te tio 0 m ns % b Ap O er pl ff y) The Collective Knowledge of Global Industry and Regulatory Experts ju ly – december 13 Guides the “What” Strategic in scope Guide 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 crosssection 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 Practice Guides the “How” Good Practice Guide “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. ...........................................13 Electronic Data Archiving.... 12 Additional GAMP® Good Practice Guides A Risk-Based Approach to GxP Process Control Systems (Second Edition)..........................................................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.......... Ventilation and Air Conditioning (HVAC) Heating..............................................14 Manufacturing Execution Systems – A Strategic and Program Management Approach..................14 Additional Investigational Products Guides Booklet Labels.........17 Process Analytical Technology (PAT) Change Management System as a Key Element of a Pharmaceutical Quality System.......................................................... ISPE Guidance Documents are produced by pharmaceutical manufacturing industry professionals and provide the practical.....................11 Maintenance.............................19 Maintenance.................6 Commissioning and Qualification Science and Risk-Based Approach for the Delivery of Facilities.....................................8 Additional Containment Guides Active Pharmaceutical Ingredients..........................................21 Medical Device Quality Systems Manual..............11 Sterile Product Manufacturing Facilities (Second Edition). and Air Conditioning (HVAC)..................... 8 Critical Utilities Ozone Sanitization of Pharmaceutical Water Systems............... and Equipment......................10 Water and Steam Systems (Second Edition)...8 Assessing the Particulate Containment Performance of Pharmaceutical Equipment (Second Edition). The 20......... and Equipment........7 Containment Risk-Based Manufacture of Pharmaceutical Products (Risk-MaPP).....11 Risk-Based Manufacture of Pharmaceutical Products (Risk-MaPP).13 Global Information Systems Control and Compliance..................20 Product Realization using QbD.............14 Investigational Products (IP) Comparator Management................ Labeling..19 Additional Project Management Guides Good Engineering Practice.................................................19 Quality by Design (QbD) Process Performance and Product Quality Monitoring System (PP&PQMS) – NEW...20 Product Realization using QbD......11 GAMP® A Risk-Based Approach to Compliant GxP Computerized Systems .............................................................................. Illustrative Example....... Inventory Clearance Biopharmaceutical Manufacturing Facilities.........................12 A Risk-Based Approach to GxP Compliant Laboratory Computerized Systems (Second Edition).... a Revision of Bulk Pharmaceutical Chemicals........16 Oral Solid Dosage Oral Solid Dosage Forms (Second Edition)....... Use promo code 2013SUMMER when ordering to receive your discount....................... Discounts do not apply to the CPIP Study Guide....................................................................... “real world” information you need to help your company build on current best practices to meet and exceed regulatory standards..15 Development of Investigational Therapeutic Biological Products............... the International Society for Pharmaceutical Engineering... Ventilation..........22 Japanese.......5 Water and Steam Systems (Second Edition)..................................................... is the world’s largest not-for-profit association serving its Members through leading scientific.....9 Additional Critical Utilities Guides Commissioning and Qualification of Pharmaceutical Water and Steam Systems........15 Introductory US Clinical Trial Materials Training Guide......6 Biotechnology Biopharmaceutical Manufacturing Facilities................15 Interactive Response Technology...................23 ......................................................10 Commissioning and Qualification............................11 Water and Steam Systems (Second Edition)..5 Active Pharmaceutical Ingredients Active Pharmaceutical Ingredients.........13 IT Infrastructure Control and Compliance..........13 A Risk-Based Approach to Operation of GxP Computerized Systems..................7 Commissioning and Qualification of Pharmaceutical Water and Steam Systems.................To order: Go to www..................10 Additional Facilities Guides Active Pharmaceutical Ingredients..4 Sterile Product Manufacturing Facilities (Second Edition)..........................18 Project Management (PM) Project Management for the Pharmaceutical Industry....22 Guidance Document Translations Available Chinese...............................................22 French..........................................7 Additional Commissioning and Qualification Guides Applied Risk Management for Commissioning and Qualification.........ISPE...ISPE.................................................... A Companion Volume to GAMP® 5............... and Warehousing Facilities...........................11 Oral Solid Dosage Forms (Second Edition)................................17 Packaging.................................21 Sterile Sterile Product Manufacturing Facilities (Second Edition)...22 German...........9 Process Gases ........4 Commissioning and Qualification of Pharmaceutical Water and Steam Systems............ Systems.........................12 A Risk-Based Approach to Compliant Electronic Records and Signatures..... visit www..................org/Guidance-Documents A Risk-Based Approach to Calibration Management (Second Edition)....................... or the Medical Device Quality Systems Manual...........20 Additional Quality by Design (QbD) Guides Change Management System as a Key Element of a Pharmaceutical Quality System...........11 Science and Risk-Based Approach for the Delivery of Facilities..................................................15 Harmonizing the Definition and Use of Non-Investigational Medicinal Products (NIMPs)...........................16 Investigational Materials Sample Retention Guide....................................................... a Revision of Bulk Pharmaceutical Chemicals..10 Biopharmaceutical Manufacturing Facilities.......................14 Heating.....12 GAMP® Good Practice Guides For full Guide descriptions....................................16 Packaging Cold Chain Management................................ a Revision of Bulk Pharmaceutical Chemicals...............................15 Comprehensive Guide to Clinical Materials...........................10 Facilities Quality Laboratory Facilities................................ Mini-Regs.................................................org/Store ISPE........................20 Regulatory Mini-Regulation Handbooks.............................6 Certification Certified Pharmaceutical Industry Professional (CPIP) Study Guide....... Systems...13 A Risk-Based Approach to Testing of GxP Systems (Second Edition).... technical and regulatory advancement throughout the pharmaceutical lifecycle............................................ Summer Sale! 20% Off all Guides now through 30 September 2013* *May not be combined with any other discount or promotion.... Concepts and Principles...........................7 Commissioning and Qualification.............. 50 New Member* $414/€334 $207/€167 Nonmember $435/€355 $217. The Guide. construction. preventing contamination. The Guide is a reference for design. commissioning and qualification of new facilities for biopharmaceutical Active Pharmaceutical Ingredients (APIs). Publication date: July 2004 Pages: 196 Bound Item #: BIO0604 Bound Pricing: Member $200/€155 $100/€77.50/€187 Nonmember $495/€395 $247. also known as drug substance.50 Individual PDF Download Item #: IGPGCQWSDL PDF Download Pricing: Member $145/€115 New Member* $414/€334 Nonmember $435/€355 ISPE Publications Catalog j uly – de ce mbe r The Commissioning and Qualification of Pharmaceutical Water and Steam Systems Guide provides an alternative approach. while the GMPs of other countries and regions are covered in the appendices. aims to apply the principles discussed in the ISPE Baseline® Guide to direct water and steam systems. visit www. based on “risk assessment” principles and “process understanding” for the commissioning and qualification of direct impact water and steam systems.50 Bound/CD Set Item #: BIOELEC Bound/CD Set Pricing: Member $340/€265 New Member $609/€484 Non-Member $640/€510 Individual PDF Download Item #: BIO0604DL PDF Download Pricing: Member $200/€155 New Member* $469/€374 Nonmember $495/€395 Commissioning and Qualification of Pharmaceutical Water and Steam Systems Publication date: February 2007 Pages: 88 Bound Item #: IGPGCQWS Bound Pricing: Member $145/€115 $72. the use of disposable equipment.50/€57. intended as a supplement to the ISPE Baseline® Guide on Commissioning and Qualification.50/€197. enhanced strategies for automation and alternative methods for protecting the integrity of the product.org/Store. 4 To order. The Guide covers in-line process analytical measurement and control.ISPE. and segregation and flow. This Guide will show you how to change your focus from a “qualify everything” approach.50 New Member* $469/€374 $234. to a more efficient and cost-effective risk-based evaluation of individual system components or process steps.Inventory Biopharmaceutical Manufacturing Facilities The Biopharmaceutical Manufacturing Facilities Baseline® Guide explores products and facilities that house biotechnological processes and specifically applies to process design ties to facility design.50/€177. . controlled processing. The Guide addresses US GMPs. testing and control levels. The Guide consolidates all of ISPE’s latest best practice recommendations on sterile manufacturing facility design into one document. operation and maintenance of new water and steam systems that meet cGMPs and comply with existing regulations and related guidance. as well as the overall impact of microbial considerations on unit operations and finished water have been added. Updated in 2011. construction. commissioning.50 Individual PDF Download Item #: STER0911DL PDF Download Pricing: Member $200/€155 New Member* $469/€374 Nonmember $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. See order form for details. allowing for better harmonization in global facility design and a wider breadth of regulatory compliance internationally.50/€187 Nonmember $495/€395 $247. New chapters covering microbiological considerations. commissioning.50/€197. and qualification of facilities designed for aseptic processing of formulated products. construction. use of sanitizers.Clearance Sterile Product Manufacturing Facilities (Second Edition) The Sterile Product Manufacturing Facilities Baseline Guide addresses the design. explanation and comparison of the cleanliness designations found in FDA. and qualification of new or renovated aseptic/ sterile manufacturing facilities. EMA and ISO guidance documents. providing continuity and longevity of vision to the Guide’s contents.50 * New Member fee includes one-year membership in ISPE – a $269/€219 value. The Guide is designed for use by industry for the design. Publication date: September 2011 Pages: 204 Bound Item #: STER0911 Bound Pricing: Member $200/€155 $100/€77. construction. Bound Item #: WAT1211 Individual PDF Download Item #: WAT1211DL PDF Download Pricing: Member $200/€155 New Member* $469/€374 Nonmember $495/€395 ISPE Publications Catalog ju ly – d ec embe r Publication date: December 2011 Pages: 264 Bound Pricing: Member $200/€155 $100/€77.50/€197. 5 . 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. the Guide contains recommendations to help facilitate compliance with the latest FDA and EMA guidance and incorporates a comprehensive tabulation. sampling. such as biofilm formation.50/€187 Nonmember $495/€395 $247.50 New Member* $469/€374 $234.50 New Member* $469/€374 $234. This white paper expands and clarifies a new concept introduced in the Guide. . you will receive the white paper. Active Pharmaceutical Ingredients (originally entitled Bulk Pharmaceutical Chemicals).org/Store. which can be used to prepare for the examination and/or as an everyday work Reference tool. Bound Item #: API0607 Individual PDF Download Item #: API0607DL Bound or PDF Download Pricing: Member $200/€155 New Member* $469/€374 Nonmember $495/€395 Biotechnology Biopharmaceutical Manufacturing Facilities See page 4 for description and special pricing (on bound version only). ISPE Publications Catalog j uly – de ce mbe r Individual PDF Download Item #: CPIPSTUDY5DL Publication date: May 2012 Pages: 32 6 To order.” by Stan Newberger and Dr. Sterile Drug Products Produced by Aseptic Processing – Current Good Manufacturing Practice (cGMP). visit www. Trish Melton. Guidance for Industry. ICH Q9.Active Pharmaceutical Ingredients Active Pharmaceutical Ingredients. This Document contains references in the public domain. Publication date: June 2007 Pages: 188 “A Risk-Based Approach to Defining Levels of Protection within API Facility Design: The Concept of Briefly Exposed (Briefly Open). 21 CFR Part 11. a Revision of Bulk Pharmaceutical Chemicals This revised Baseline® Guide builds on the original principles of ISPE’s Baseline® Guide Volume 1. PDF Download Pricing: Member $40/€32 Nonmember $60/€48 †Emerging Economy Discount is not available on this item. Bound Item #: BIO0604 Individual PDF Download Item #: BIO0604DL Publication date: July 2004 Pages: 196 Bound/CD Set Item #: BIOELEC Certification Certified Pharmaceutical Industry Professional (CPIP) Study Guide The electronic Study Guide provides a detailed description of knowledge elements to be included in the CPIP certification program examination. FDA Draft Guidance for Industry PAT – Framework for Innovative Pharmaceutical Manufacturing and Quality Assurance and much more. It also incorporates and builds on new regulations and guidance. BONUS White Paper: With purchase of API.ISPE. such as: ICH Q7. GAMP® 4. systems and equipment. The ISPE Guide: Science and Risk-Based Approach for the Delivery of Facilities. Q9 and Q10 and ASTM E2500. Bound Item #: IGPGCQWS Individual PDF Download Item #: IGPGCQWSDL Publication date: February 2007 Pages: 88 * New Member fee includes one-year membership in ISPE – a $269/€219 value. Specific implementation guidance is given on meeting the expectations of global regulators and is compatible with ICH documents (Q8 (R2).and riskbased approach for demonstrating that pharmaceutical and biopharmaceutical facilities.Commissioning and Qualification Science and Risk-Based Approach for the Delivery of Facilities. poses significant challenges to manufacturers. ju ly – d ec embe r Individual PDF Download Item #: CQ0101DL Publication date: March 2001 Pages: 142 ISPE Publications Catalog Bound Item #: CQ0101 7 .and risk-based approaches applied in ICH Q8. Systems. and Equipment provides direction to industry on the implementation of a science. equipment and associated automation are fit for intended use and comply with regulatory requirements. Bound or PDF Download Pricing: Member $200/€155 New Member* $469/€374 Nonmember $495/€395 Bound/CD Item #: CQELEC Bound/CD Set Pricing: Member $340/€265 New Member* $609/€484 Nonmember $640/€510 Commissioning and Qualification of Pharmaceutical Water and Steam Systems See page 4 for description and special pricing (on bound version only). engineering professionals and equipment suppliers. Systems. linking traditional terminology and approaches to the newer science. Q9 and Q10) and ASTM E2500-07. See order form for details. commissioning and qualifying manufacturing facilities. utilities and equipment. design and verification of facilities. Publication date: June 2011 Pages: 120 The aim of the Guide is to facilitate the translation of the scientific knowledge about the product and process into documented specification. constructing. Bound Item #: IGPGARMCQ Individual PDF Download Item #: IGPGARMCQDL Publication date: October 2011 Pages: 140 Bound or PDF Download Pricing: Member $145/€115 New Member* $414/€334 Nonmember $435/€355 Commissioning and Qualification Focuses on engineering approaches and practices for timely. systems. and Equipment The successful delivery of manufacturing facilities regulated by various authorities. cost-effective designing. Bound Item #: IGFSE Individual PDF Download Item #: IGFSEDL Bound or PDF Download Pricing: Member $200/€155 New Member* $469/€374 Nonmember $495/€395 Additional Commissioning and Qualification Guides Applied Risk Management for Commissioning and Qualification Illustrates the application of quality risk management to traditional C&Q practices. Bound Item #: API0607 Individual PDF Download Item #: API0607DL Publication date: June 2007 Pages: 188 Bound or PDF Download Pricing: Member $200/€155 New Member* $469/€374 Nonmember $495/€395 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. Typically. bulk pharmaceutical chemicals. The control strategies to manage risk can vary from administrative to full dedication or segregation. construction. Publication date: September 2010 Pages: 152 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 crosscontamination causing an undue risk to patient safety. a Revision of Bulk Pharmaceutical Chemicals Provides guidance on design. qualification and validation of Active Pharmaceutical Ingredients (APIs) facilities. visit www. some combination of control strategies may be necessary. Individual PDF Download Item #: IGPGAPC2DL Publication date: May 2012 Pages: 104 Bound or PDF Download Pricing: Member $145/€115 New Member* $414/€334 Nonmember $435/€355 ISPE Publications Catalog j uly – de ce mbe r Bound Item #: IGPGAPC2 8 To order.Containment Risk-Based Manufacture of Pharmaceutical Products (Risk-MaPP) The ISPE Baseline® Guide: Risk-Based Manufacture of Pharmaceutical Products (RiskMaPP) provides a scientific risk-based approach based on ICH Q9 to manage the risk of cross-contamination to maintain product quality and operator safety. commissioning. 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. Bound Item #: RISK0910 Individual PDF Download Item #: RISK0910DL Bound or PDF Download Pricing: Member $200/€155 New Member* $469/€374 Nonmember $495/€395 Additional Containment Guides Active Pharmaceutical Ingredients. This Guide should be used in conjunction with local and/or applicable (multinational manufacturing platforms) regulatory requirements and other guidance documents already available to the pharmaceutical manufacturing industry. 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.ISPE.org/Store. intermediates and non-APIs (excipients) facilities. . This approach is intended to allow manufacturers to contain manufacturing cost while facilitating safe and affordable drug product. including regulatory considerations and other factors companies should take into account when deciding to use ozone vs. as well as associated advantages and disadvantages of using ozone as a water sanitization method. Bound Item #: IGPGOZONE Individual PDF Download Item #: IGPGOZONEDL Bound or PDF Download Pricing: Member $145/€115 New Member* $414/€334 Nonmember $435/€355 Process Gases The ISPE Good Practice Guide: Process Gases aims to define current good practices within pharmaceutical manufacturing applications. Information is provided on how to avoid increasing facility installation and operational costs. such as the EMA. The Guide also addresses international guidelines and regulations. construction. commissioning and qualification processes for gas systems used to support production. The Guide aims to clarify gas system issues critical to product quality for the production of biopharmaceutical and pharmaceutical drug substances and drug products. more efficient and more cost-effective way to sanitize pharmaceutical water and how they can be incorporated into both new and retrofitted facilities. The Guide promotes science and risk-based approaches to provide an effective basis for the planning. other sanitization approaches. the Guide addresses the process of designing. why they can be a safer. and is the first industry Guidance Document to take a holistic view of these issues. 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. Publication date: July 2012 Pages: 144 The Guide helps companies better understand what ozone systems are. It discusses specific system requirements. providing information to allow organizations to benchmark their practices and improve upon them. constructing. Bound Item #: IGPGPGAS Bound or PDF Download Pricing: Member $145/€115 New Member* $414/€334 Nonmember $435/€355 ISPE Publications Catalog ju ly – d ec embe r Individual PDF Download Item #: IGPGPGASDL * New Member fee includes one-year membership in ISPE – a $269/€219 value. 9 . See order form for details.Critical Utilities Ozone Sanitization of Pharmaceutical Water Systems The ISPE Good Practice Guide: Ozone Sanitization of Pharmaceutical Water Systems provides important insight into the design and use of pharmaceutical ozone sanitization systems. commissioning and qualifying a process gas system regulated by the FDA or other regulatory authority. Publication date: July 2011 Pages: 148 Specifically. The Guide provides an overview of ozone sanitization systems. org/Store. qualification and validation of Active Pharmaceutical Ingredients (APIs) facilities. Bound Item #: IGPGCQWS Individual PDF Download Item #: IGPGCQWSDL Publication date: February 2007 Pages: 88 Water and Steam Systems (Second Edition) See page 5 for description and special pricing (on bound version only). commissioning. intermediates and non-APIs (excipients) facilities. To order. construction. 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. ISPE Publications Catalog j uly – de ce mbe r Bound Item #: API0607 10 Individual PDF Download Item #: API0607DL Publication date: June 2007 Pages: 188 Bound or PDF Download Pricing: Member $200/€155 New Member* $469/€374 Nonmember $495/€395 Biopharmaceutical Manufacturing Facilities See page 4 for description and special pricing (on bound version only). .Additional Critical Utilities Guides Commissioning and Qualification of Pharmaceutical Water and Steam Systems See page 4 for description and special pricing (on bound version only). bulk pharmaceutical chemicals. 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. Bound Item #: IGPGQLF Publication date: September 2012 Pages: 176 Individual PDF Download Item #: IGPGQLFDL Bound or PDF Download Pricing: Member $145/€115 New Member* $414/€334 Nonmember $435/€355 Additional Facilities Guides Active Pharmaceutical Ingredients. a Revision of Bulk Pharmaceutical Chemicals Provides guidance on design. Bound Item #: BIO0604 Individual PDF Download Item #: BIO0604DL Publication date: July 2004 Pages: 196 Bound/CD Set Item #: BIOELEC * New Member fee includes one-year membership in ISPE – a $269/€219 value. visit www.ISPE. Bound Item #: WAT1211 Individual PDF Download Item #: WAT1211DL Publication date: December 2011 Pages: 264 Facilities Quality Laboratory Facilities ISPE has produced the industry’s first Guidance Document to establish a baseline for the design of Quality Laboratory Facilities. See order form for details. engineers and builders about the function. operation and design parameters that must be met. Bound Item #: RISK0910 Individual PDF Download Item #: RISK0910DL Publication date: September 2010 Pages: 152 Bound or PDF Download Pricing: Member $200/€155 New Member* $469/€374 Nonmember $495/€395 Science and Risk-Based Approach for the Delivery of Facilities. Bound Item #: CQ0101 Individual PDF Download Item #: CQ0101DL Publication date: March 2001 Pages: 142 Bound or PDF Download Pricing: Member $200/€155 New Member* $469/€374 Nonmember $495/€395 Bound/CD Set Pricing: Item #: CQELEC Member $340/€265 New Member* $609/€484 Nonmember $640/€510 Maintenance Provides practical solutions and tools for ensuring technical and regulatory accuracy and cost-effective compliance in a new or existing maintenance program.Additional Facilities Guides continued Commissioning and Qualification See page 7 for description. as well as a risk-based approach to regulatory compliance relating to the design. and Equipment See page 7 for description. Bound Item #: WAT1211 Individual PDF Download Item #: WAT1211DL Publication date: December 2011 Pages: 264 ISPE Publications Catalog Individual PDF Download Item #: STER0911DL Publication date: September 2011 Pages: 204 ju ly – d ec embe r Bound Item #: STER0911 11 . Water and Steam Systems (Second Edition) See page 5 for description and special pricing (on bound version only). construction and validation of OSD manufacturing facilities. Systems. Bound Item #: IGPGMAINT Individual PDF Download Item #: IGPGMAINTDL Publication date: May 2009 Pages: 108 Bound or PDF Download Pricing: Member $145/€115 New Member* $414/€334 Nonmember $435/€355 Oral Solid Dosage Forms (Second Edition) Addresses the latest interpretation of GMP requirements. Bound Item #: OSD1109 Individual PDF Download Item #: OSD1109DL Publication date: November 2009 Pages: 188 Bound or PDF Download Pricing: Member $200/€155 New Member* $469/€374 Nonmember $495/€395 Risk-Based Manufacture of Pharmaceutical Products (Risk-MaPP) See page 8 for description. Bound Item #: IGFSE Individual PDF Download Item #: IGFSEDL Publication date: June 2011 Pages: 120 Bound or PDF Download Pricing: Member $200/€155 New Member* $469/€374 Nonmember $495/€395 Sterile Product Manufacturing Facilities (Second Edition) See page 5 for description and special pricing (on bound version only). electronic batch recording. key diagrams. emphasizing well-documented.org/Store. Bound Item #: 4ERS Individual PDF Download Item #: 4ERSDL Publication date: February 2005 Pages: 240 Bound or PDF Download Pricing: Member $145/€115 New Member* $414/€334 Nonmember $435/€355 ISPE Publications Catalog j uly – de ce mbe r A Risk-Based Approach to GxP Compliant Laboratory Computerized Systems (Second Edition) 12 Contains practical. implementation and operations can use to verify laboratory systems are fit for their intended use. while also enabling innovation and technological advance. Bound Item #: GGPGLABCS2 Individual PDF Download Item #: GGPGLABCS2DL Publication date: October 2012 Pages: 160 Bound or PDF Download Pricing: Member $145/€115 New Member* $414/€334 Nonmember $435/€355 To order. The revised Guide describes a flexible riskbased approach to compliant GxP regulated computerized systems. Publication date: February 2008 Pages: 356 CD accompanying the Guide provides supporting materials. documentation and corrective actions essential to regulatory compliance. including differences between GAMP® 4 and GAMP® 5. risk-based approach that those involved in managing laboratory computerized system acquisition. calibration program management. . validated systems and the application of appropriate operational controls. GAMP® 5 also contains new information on outsourcing. templates. A robust quality risk management process based on ICH Q9 principles is central to the approach. Bound Item #: GGPGCALMGMT2 Individual PDF Download Item #: GGPGCALMGT2DL Publication date: November 2010 Pages: 124 Bound or PDF Download Pricing: Member $145/€115 New Member* $414/€334 Nonmember $435/€355 A Risk-Based Approach to Compliant Electronic Records and Signatures Presents a comprehensive approach for compliant electronic records and signatures. (CD is Windows compatible only. visit www. example documents and background information. based on scalable specification and verification.ISPE. end user applications (such as spreadsheets and small database applications) and patch management.) Bound Item #: 5BOUND Individual PDF Download Item #: 5BOUNDDL Bound or PDF Download Pricing: Member $250/€195 New Member* $519/€414 Nonmember $545/€435 GAMP® Good Practice Guides 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. forms.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. See order form for details. providing a high-level overview of the approach and guidance on how activities might be scaled based on risk to product quality. Bound Item #: 4EDA Individual PDF Download Item #: 4EDADL Publication date: July 2007 Pages: 152 Bound or PDF Download Pricing: Member $145/€115 New Member* $414/€334 Nonmember $435/€355 Global Information Systems Control and Compliance Individual PDF Download Item #: 4GISDL Publication date: November 2005 Pages: 96 Bound or PDF Download Pricing: Member $145/€115 New Member* $414/€334 Nonmember $435/€355 * New Member fee includes one-year membership in ISPE – a $269/€219 value. Bound Item #: GGPGOGCS Individual PDF Download Item #: GGPGOGCSDL Publication date: January 2010 Pages: 216 Bound or PDF Download Pricing: Member $145/€115 New Member* $414/€334 Nonmember $435/€355 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. Bound Item #: GGPGPCS2 Individual PDF Download Item #: GGPGPCS2DL Publication date: February 2011 Pages: 196 Bound or PDF Download Pricing: Member $145/€115 New Member* $414/€334 Nonmember $435/€355 A Risk-Based Approach to Operation of GxP Computerized Systems. Bound Item #: GGPGTEST2 Individual PDF Download Item #: GGPGTEST2DL Publication date: December 2012 Pages: 276 Bound or PDF Download Pricing: Member $145/€115 New Member* $414/€334 Nonmember $435/€355 Electronic Data Archiving Provides a rational and scaleable approach to electronic data archiving to help organizations achieve and maintain regulatory compliance and effectively manage electronic records. 13 . automated testing and non-linear development. with updated information on cloud computing.Additional GAMP® Good Practice Guides A Risk-Based Approach to GxP Process Control Systems (Second Edition) Describes the system lifecycle from concept to retirement. ISPE Publications Catalog Bound Item #: 4GIS ju ly – d ec embe r Provides an understanding of the issues faced by teams that are tasked with completing a global deployment of an IT system. A Companion Volume to GAMP® 5 Helps organizations achieve compliant computerized systems that are fit for intended use. with comprehensive guidance for maintaining control of regulated systems throughout their operational life. system novelty and complexity. including control and regulatory compliance issues. 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. delays and potential case study inaccuracies that might result from faulty comparator management. Bound Item #: GGPGMES Individual PDF Download Item #: GGPGMESDL Publication date: February 2010 Pages: 144 Bound or PDF Download Pricing: Member $145/€115 New Member* $414/€334 Nonmember $435/€355 Heating. Bound Item #: IGPGHVAC Individual PDF Download Item #: IGPGHVACDL Bound or PDF Download Pricing: Member $145/€115 New Member* $414/€334 Nonmember $435/€355 Publication date: September 2009 Pages: 288 Investigational Products (IP) Comparator Management ISPE Publications Catalog j uly – de ce mbe r The ISPE Good Practice Guide: Comparator Management is the pharmaceutical industry’s first-ever resource for comparator processes. including how to set up a good sourcing team. visit www. Publication date: March 2012 Pages: 84 Bound Item #: IGPGCMGMT Individual PDF Download Item #: IGPGCMGMTDL Bound or PDF Download Pricing: Member $145/€115 New Member* $414/€334 Nonmember $435/€355 To order. . It also provides options to be considered in creating a design that has low lifecycle cost and that is sustainable. It has been developed to use as a central reference source that establishes strategic and tactical considerations related to comparator sourcing. including the need to identify. qualify and control those aspects impacted by GxP. The Guide also discusses good practices for blinding and releasing a comparator for use. Bound Item #: 4IT Individual PDF Download Item #: 4ITDL Publication date: September 2005 Pages: 128 Bound or PDF Download Pricing: Member $145/€115 New Member* $414/€334 Nonmember $435/€355 Manufacturing Execution Systems – A Strategic and Program Management Approach Presents 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. 14 The Guide will also explain the risks involved with ineffective comparator methods. It identifies good practices for making sourcing decisions. and provide companies with strategies for avoiding the costs. 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. information flow and human interaction.ISPE.org/Store.Additional GAMP® Good Practice Guides continued IT Infrastructure Control and Compliance Provides comprehensive guidance for compliant IT Infrastructure platforms. Ventilation. Ventilation and Air Conditioning (HVAC) Heating. includes recommendations and justification for placement of required information. 15 . Individual PDF Download Item #: IGPGNIMPSDL Publication date: January 2013 Pages: 56 PDF Download Pricing: Member $99/€80 New Member* $368/€299 Nonmember $390/€315 Interactive Response Technology Describes how the pharmaceutical industry can apply interactive response technology to support various clinical trial activities. building on the topics covered in the Introductory US Clinical Trial Materials Training Guide. including expiry date management and program pooling. PDF Download Pricing: Member $145/€115 New Member* $414/€334 Nonmember $435/€355 ISPE Publications Catalog ju ly – d ec embe r Individual PDF Download Item #: IGPGIRTDL Publication date: November 2011 Pages: 92 * New Member fee includes one-year membership in ISPE – a $269/€219 value. Individual PDF Download Item #: IGPGBKLBDL Publication date: March 2013 Pages: 42 PDF Download Pricing: Member $99/€80 New Member* $368/€299 Nonmember $390/€315 Comprehensive Guide to Clinical Materials A Handbook for Training Clinical Materials Professionals Provides tools for the development of in-house training sessions for advanced training. Bound Item #: IGPGBIOL Individual PDF Download Item #: IGPGBIOLDL Publication date: August 2007 Pages: 92 Bound or PDF Download Pricing: Member $145/€115 New Member* $414/€334 Nonmember $435/€355 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. Bound Item #: CMHB2006 Individual PDF Download Item #: CMHB2006DL Publication date: July 2006 Pages: 120 Bound or PDF Download Pricing: Member $145/€115 New Member* $414/€334 Nonmember $435/€355 Development of Investigational Therapeutic Biological Products Discusses the major issues confronting a biopharmaceutical company in moving therapeutic biological products from the laboratory to the clinic and beyond. including criteria for classifying NIMPs and an overview of current regulatory requirements. See order form for details.Additional Investigational Products Guides Booklet Labels Provides suggestions for effective and compliant booklet label design. assists users in determining quantity and retention time for sample products. it addresses the latest interpretation of GMP requirements. 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. visit www. 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.ISPE. Bound Item #: OSD1109 Individual PDF Download Item #: OSD1109DL Bound or PDF Download Pricing: Member $200/€155 New Member* $469/€374 Nonmember $495/€395 ISPE Publications Catalog j uly – de ce mbe r Publication date: November 2009 Pages: 188 16 To order. practices and regulatory requirements. Bound Item #: CMRETGD Publication date: July 2003 Bound Pricing: Member $7/€6 Nonmember $17/€14 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.org/Store. such as continuous processing and implementation of process analytical technology.Additional Investigational Products Guides continued Introductory US Clinical Trial Materials Training Guide Designed 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 #: CMGUIDE Publication date: October 2002 Pages: 44 Bound Pricing: Member $15/€12 Nonmember $25/€20 Investigational Materials Sample Retention Guide Supplement to the Introductory US Clinical Trial Materials Training Guide. Specifically. as well as a riskbased approach to regulatory compliance relating to the design. establish. construction and commissioning and qualification of packaging. cost-effective system to ensure a safe. label mix-up and misbranding. commissioning and verification of the fixed and passive systems within the cold chain. The Guide helps companies meet CGMP requirements for these types of facilities while avoiding product adulteration. The Guide is intended to provide a robust. document. the complexity of these products and the complexity of the associated supply chain are causes for concern.Packaging Cold Chain Management Increasing volumes of cold products. See order form for details. A dedicated team of subject matter experts from across the pharmaceutical and biopharmaceutical industries developed the ISPE Good Practice Guide: Cold Chain Management. maintain and improve industry good practice for product requiring controlled cold conditions. Bound Item #: IGPGCCM Individual PDF Download Item #: IGPGCCMDL Bound or PDF Download Pricing: Member $145/€115 New Member* $414/€334 Nonmember $435/€355 Packaging. Publication date: May 2011 Pages: 140 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. effective product is received by the end users. implement. such as filling of the dosage form in the immediate container/closure system and other packaging. and Warehousing Facilities The ISPE Good Practice Guide: Packaging. It addresses Quality by Design principles and establishes consistent guidelines that can be incorporated into the design and/or reconfiguration of PACLAW facilities. Bound Item #: IGPGPACLAW ISPE Publications Catalog Individual PDF Download Item #: IGPGPACLAWDL Bound or PDF Download Pricing: Member $145/€115 New Member* $414/€334 Nonmember $435/€355 ju ly – d ec embe r Publication date: June 2012 Pages: 112 This Guide presents an approach to satisfying CGMPs while providing realistic solutions to business and operational concerns. product mix-up. and Warehousing Facilities is the industry’s only guidance relating to the design. Labeling. 17 . Labeling. 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. labeling and warehousing (PACLAW) facilities. compare their processes to established best practices and demonstrate compliance to regulatory agencies. Organizations need adequate control over cold chain of pharmaceutical and biopharmaceutical distribution systems. labeling and warehousing processes. design. * New Member fee includes one-year membership in ISPE – a $269/€219 value. Companies can use this Guide to learn how to ensure that their PACLAW processes are efficient. ISPE recognized the need for guidance in this area. It covers facility design issues for most primary packaging operations. The Guide is intended to provide practical guidance to assist in the specification. 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. org/2013AnnualMeeting to register To order. visit www. DC USA Packed with educational content to address all experience levels and job functions.ISPE.ISPE.ISPE.org/Store. 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. New Jersey USA 18 Be proactive. real-world strategies for implementing the change management recommendations of ICH Q10. Visit www.org/2013ProcessValidationConference to register ISPE Annual Meeting: Quality Throughout the Product Lifecycle 3 – 6 November 2013 • Washington. advances in bioprocessing and streamlined compliance programs. Visit www. Visit www. It provides clear guidance on achieving compliant and consistent change management systems and describes how to implement compliant change management systems within a PQS. Visit www. Understand how these expectations can be transformed into practical actions and business processes. is the only change management guide written expressly for the pharmaceutical industry.ISPE.org/2013ProactiveComplianceConference to register Process Validation Conference 9 – 10 October 2013 • New Brunswick. It provides practical. .ISPE. 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. not reactive! Acquire “Best in Class” tools and strategies to transform your company’s approach to compliance.Process Analytical Technology (PAT) Change Management System as a Key Element of a Pharmaceutical Quality System The ISPE PQLI Guide: Part 3 – Change Management System as a Key Element of a Pharmaceutical Quality System. North Carolina USA Discover how experts will develop and validate projects using next-generation manufacturing systems. technologies and quality management techniques. Individual PDF Download Item #: PQLI3DL PDF Download Pricing: Member $99/€80 New Member* $368/€299 Nonmember $390/€315 Don’t Miss these Upcoming Conferences! Biotechnology 27 – 28 August 2013 • Durham. the Annual Meeting brings together influential industry and regulatory experts to provide you with the latest in innovative processes.org/2013BiotechConference to register Proactive Compliance ISPE Publications Catalog j uly – de ce mbe r 7 – 8 October 2013 • New Brunswick. Publication date: June 2012 Pages: 56 The PQLI Guide on Change Management outlines potential product lifecycle approaches to the change management system of a Pharmaceutical Quality System (PQS). or as a stand-alone change management manual. New Jersey USA New expectations are bringing about significant changes in Process Validation approaches. 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 #: IGPGMAINT Bound or PDF Download Pricing: Member $145/€115 New Member* $414/€334 Nonmember $435/€355 ISPE Publications Catalog ju ly – d ec embe r Individual PDF Download Item #: IGPGMAINTDL Publication date: May 2009 Pages: 108 * New Member fee includes one-year membership in ISPE – a $269/€219 value. Bound Item #: IGPGPM Publication date: November 2011 Pages: 282 Individual PDF Download Item #: IGPGPMDL Bound or PDF Download Pricing: Member $145/€115 New Member* $414/€334 Nonmember $435/€355 Additional Project Management Guides Good Engineering Practice Provides proven and accepted engineering methods. costeffective and well-documented solutions to meet user requirements and regulatory compliance. procedures and practices that provide appropriate. The Guide discusses: the tools and techniques supporting project delivery. See order form for details.Project Management (PM) Project Management for the Pharmaceutical Industry The 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. Bound Item #: IGPGGEP Individual PDF Download Item #: IGPGGEPDL Publication date: December 2008 Pages: 196 Bound or PDF Download Pricing: Member $145/€115 New Member* $414/€334 Nonmember $435/€355 Maintenance Provides practical solutions and tools for ensuring technical and regulatory accuracy and cost-effective compliance in a new or existing maintenance program. 19 . Responsibilities of the role are discussed for this new concept emerging from industry. . your company can improve opportunities to maintain compliance with global regulations and improve confidence that a process runs as intended.org/Store. By establishing a PP&PQMS. Individual PDF Download Item #: PQLI3DL Publication date: June 2012 Pages: 56 PDF Download Pricing: Member $99/€80 New Member* $368/€299 Nonmember $390/€315 Product Realization using QbD. from development through product discontinuation. small and large molecule and all phases of product lifecycle. Individual PDF Download Item #: PQLI4DL PDF Download Pricing: Member $99/€80 New Member* $368/€299 Nonmember $390/€315 Additional Quality by Design (QbD) Guides Change Management System as a Key Element of a Pharmaceutical Quality System See page 18 for description. transfer to and establishment of. Publication date: June 2013 Pages: 80 This PQLI Guide is relevant for new and existing products. Design Space and Control Strategy and addresses product and process development.ISPE. visit www.Quality by Design (QbD) Process Performance and Product Quality Monitoring System (PP&PQMS) – NEW The 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. Bound Item #: PQLI2 Individual PDF Download Item #: PQLI2DL Publication date: November 2011 Pages: 232 Bound or PDF Download Pricing: Member $145/€115 New Member* $414/€334 Nonmember $435/€355 To order.and risk-based approaches. Pharmaceutical Quality System. The Guide introduces the role of Quality Steward as an owner of product quality. Illustrative Example 20 Product 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 #: PQLI1 Individual PDF Download Item #: PQLI1DL Publication date: November 2011 Pages: 188 Bound or PDF Download Pricing: Member $145/€115 New Member* $414/€334 Nonmember $435/€355 ISPE Publications Catalog j uly – de ce mbe r Product Realization using QbD. Concepts and Principles Product Quality Lifecycle Implementation® (PQLI®) from Concept to Continual Improvement Part 1 includes the topics of Criticality. commercial manufacture using science. or are represented. referred to as the pharmaceutical quality system. labeling. Processing. and the facilities and controls used for. installation and servicing of all finished devices intended for human use. Item #: GMP047 Pricing: $5/€4 ICH Q11 – Development and Manufacture of Drug Substances This ICH guidance describes approaches to developing and understanding the manufacturing process of the drug substance including both chemical entities and biotechnological/biological entities. Packing. It is also intended to help ensure that APIs meet the quality and purity characteristics that they purport. Item #: GMP050 Pricing: $5/€4 Medical Device Quality Systems Manual This manual covers requirements of the Quality System regulation that manufacturers of medical devices must consider when they design devices. Item #: GMP044 Pricing: $5/€4 ICH Q7A – Active Pharmaceutical Ingredients This guidance represents the FDA’s current thinking regarding GMPs for manufacturing APIs under an appropriate system for managing quality as developed by ICH. contract manufacture. or when they manufacture. to possess. or Holding of Drugs. Item #: GMP051 Pricing: $5/€4 21 . has the identity and strength and meets the quality and purity standards it is represented to possess.Regulatory Mini-Regulation Handbooks These handy pocket-size booklets are an ideal way to keep everyone informed of US FDA and ICH regulations and guidelines. reliable and equivalent to paper records. See order form for details. repack or relabel finished medical devices intended to be commercially distributed. remanufacture. the design. Item #: GMP049 Pricing: $5/€4 21 CFR Part 820 – Medical Devices This guidance issued by the FDA governs the methods used in. guidance on the principles and some tools of quality risk management that can enable more effective and consistent risk-based decisions. specifically. packaging. labeling or holding operations for Dietary Supplements. ju ly – d ec embe r 21 CFR Part 11 – Electronic Records This guidance issued by the FDA defines the criteria under which electronic records and electronic signatures are considered trustworthy. Item #: GMP036 Pricing: $5/€4 21 CFR Parts 210 and 211 – Manufacturing. Item #: GMP046 Pricing: $5/€4 ICH Q10 – Quality Systems This ICH guidance assists manufacturers by describing a model for an effective quality management system for the pharmaceutical industry. General and Current Good Manufacturing Practice for Finished Pharmaceuticals This guidance issued by the FDA contains the minimum CGMP for methods to be used to assure the drug meets the requirements of safety. It also contains model procedures and sample forms. Throughout this guidance. 21 CFR Part 111 – Dietary Supplements This guidance issued by the FDA defines the criteria for CGMP in manufacturing. Item #: GMP035 Pricing: $5/€4 ICH Q8 (R2) – Pharmaceutical Development The Q8 parent guidance describes the suggested contents for the Pharmaceutical Development section of a regulatory submission in the ICH M4 Common Technical Document format. the term pharmaceutical quality system refers to the ICH Q10 model. manufacture. process. Item #: GMP048 Pricing: $5/€4 ICH Q9 – Quality Risk Management This ICH guidance offers a systematic approach to quality risk management. This is a must-have for every medical device manufacturing plant! Bound Item#: GMP039 Publication date: December 1996 Pages: 300+ Bound Pricing: Member $40/€31 Nonmember $45/€35 * New Member fee includes one-year membership in ISPE – a $269/€219 value. Item #: GMP045 Pricing: $5/€4 ISPE Publications Catalog 21 CFR Part 4 – Combination Products This guidance issued by the FDA outlines the CGMP requirements applicable to combination products. storage. packaging. ISPE. visit www.ISPE.org/Guidance-Documents. French • GAMP® 5: A Risk-Based Approach to Compliant GxP Computerized Systems (Fifth Edition) To purchase.org/Store.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.ISPE. visit www.Sterile Sterile Product Manufacturing Facilities (Second Edition) See page 5 for description and special pricing (on bound version only). 22 To order. ISPE Publications Catalog j uly – de ce mbe r Translated Guidance Documents are available in printed bound format unless otherwise noted. visit www. Bound Item #: STER0911 Individual PDF Download Item #: STER0911DL Publication date: September 2011 Pages: 204 Guidance Document Translations Available 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.ISPE.org/Store. visit www. including Overview. contact the Japan Affiliate at www.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.org. See order form for details. * New Member fee includes one-year membership in ISPE – a $269/€219 value. Criticality. 23 .jp.gr.ISPE. Design Space. and Control Strategy (First Edition) • Part 2 – Product Realization using Quality by Design (QbD): Illustrative Example (First Edition) ISPE Publications Catalog ju ly – d ec embe r To purchase. Members enjoy significant discounts on ISPE Guidance Documents. Start Your Journey Regardless of where you are in your career. To order. and much more. ISPE provides critical and timely opportunities for you to update your skills. • We work to keep our membership informed of the latest technological and regulatory trends occurring in the pharmaceutical marketplace. 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.ISPE.ISPE. Learn more about how joining ISPE can help give you a competitive edge. visit www.org/Store. • 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. Visit www.org/Membership . learn about new technologies and advancements. 24 • ISPE includes a membership rich with diversity and offering a broad representation of all pharmaceutical professionals. and collaborate with industry leaders. Conference Registrations.Membership has its benefits ISPE has something for you! ISPE Publications Catalog j uly – de ce mbe r ISPE. Training and Online Learning. contact person and telephone number.org/emergingeconomylist for eligible countries. please provide your UPS. You may also purchase publications online at www. PDF downloads are available for five (5) days only from date of purchase.. 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Don’t forget to add the appropriate shipping charge when filling out the order form. Westshore Blvd. including shipping address. Visit www. Members in Emerging Economy Countries receive 50 percent off original single copy price. CDs must be unopened and hard copy publications must be in their original. Cyberhub Singapore 339914 Prices are good through 31 December 2013. We encourage you to return any items using a traceable shipping method. or Federal Express account number on the order form and do not include shipping charges in your total. CDs are available while supplies last. See order form for details. 300 B-1150 Brussels. Please note that ISPE does not pay customs or duties on international shipping. If your preferred method of payment is electronic funds transfer. MasterCard and American Express credit cards. No drop shipments.org. #0402/06. All orders are shipped from the US. Checks for orders in USD must be drawn on a US bank and payable in US dollars. 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The ISPE Professional Certification Commission provides support throughout the process.org Order your study guide today see page 6 for details ® . The pharmaceutical industry is a continuously changing environment. therefore. visit www. see chart p. I elect ISPE industry membership (a $269/€219 value). Item # 1 N/A Title Unit Price ($ or €) ISPE Industry Membership (One Year) $269/€219 Total Choose membership price for all items PUBLICATIONS SUBTOTAL Item #CPIPSTUDY5DL Certified Pharmaceutical Industry Professional™ 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 information MUST accompany order. check must be drawn on US Bank) Bill Credit Card . Florida and North Carolina residents add state sales tax CA (7. Membership is non-transferable. Yes. ISPE does not pay customs or duties on international shipping. 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Florida 33609 USA Tel: +1-813-960-2105 Fax: +1-813-264-2816 Email: [email protected] Global Headquarters 600 N..org .org www.com ISPE Asia Pacific Office 20 Bendemeer Road #04-02. Cyberhub Singapore 339914 Tel: +65-6496-5502 Fax: +65-6496-5599 Email: [email protected]. 300 B-1150 Brussels. Wise Logic International Centre 66 North Shan Xi Road Shanghai.org/Store ISPE European Office Avenue de Tervueren. China 200041 Tel: +86-21-51081512 Fax: +86-21-5116-0260 Email: china@ispe. Belgium Tel: +32-2-743-4422 Fax: +32-2-743-1550 Email: [email protected] ISPE China Office Suite 2302. Westshore Blvd. Suite 900 Tampa.