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The Collective Knowledge of Global
Industry and Regulatory Experts

F U T U R E P U B L I C AT I O N S !
ISPE plans to publish the following guides:
ISPE Good Practice Guide: Operations Management
ISPE Baseline Guide: Oral Solid Dosage Forms (3rd Edition)
ISPE Good Practice Guide: Controlled Temperature Chamber Mapping
ISPE Good Practice Guide: Decommissioning of Pharmaceutical Equipment and Facilities


3
Baseline Pharmaceutical Engineering Guide Series .......................................................................................3
GAMP Guidance Documents ..........................................................................................................................................5

ISPE Guides, Good Practice Guides and Handbooks ...................................................................................8

easy ways PQLI .................................................................................................................................................................................................14

to order
Good
Guide Practice

1
Order Online at FOR NEW AND RENOVATED FACILITIES
Guide

www.ISPE.org/Store

2
Mail Order Form

Regulatory
ISPE
600 N. Westshore Blvd.,
Suite 900
Tampa, Florida 33609 USA
Mini-Regulation Handbooks
These handy pocket-size booklets are an ideal way to keep everyone informed of US FDA and ICH regulations and guidelines.

3
Fax Order Form
Fax: +1-813-264-2816 21 CFR Part 4 Combination Products ICH Q7A Active Pharmaceutical Ingredients
Email ask@ispe.org Item #: GMP051 Pricing: $5/4 Item #: GMP045 Pricing: $5/4

21 CFR Part 11 Electronic Records ICH Q8 (R2) Pharmaceutical Development

Item #: GMP044 Pricing: $5/4 Item #: GMP048 Pricing: $5/4
2016

21 CFR Part 111 Dietary Supplements ICH Q9 Quality Risk Management

Item #: GMP049 Pricing: $5/4 Item #: GMP046 Pricing: $5/4
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Questions?
21 CFR Part 820 Medical Devices ICH Q10 Quality Systems
Item #: GMP036 Pricing: $5/4 Item #: GMP047 Pricing: $5/4
+1-813-960-2105
21 CFR Parts 210 and 211 Manufacturing, Processing, ICH Q11 Development and Manufacture of
Email ask@ispe.org Packing, or Holding of Drugs; General and Current Good Drug Substances
ISPE Publications Catalog

Manufacturing Practice for Finished Pharmaceuticals Item #: GMP050 Pricing: $5/4

Item #: GMP035 Pricing: $5/4

Multiple Visit www.ISPE.org/Guidance-Documents/Translations for a list of titles available in

Languages
Chinese, French, German, Japanese, and Spanish.

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

Baseline
Pharmaceutical Engineering Guides
Active Pharmaceutical Ingredients, Biopharmaceutical Manufacturing
a Revision of Bulk Pharmaceutical Facilities (Second Edition)
Chemicals The biopharmaceutical industry has adapted to reflect
This revised Guide incorporates and builds on new available technologies, products with more focused patient
regulations and guidance, such as: ICH Q7, ICH Q9, GAMP populations, regulatory conditions, and continued pressures
4, 21 CFR Part 11, Guidance for Industry, Sterile Drug on costs.
Products Produced by Aseptic Processing Current Good
This revised Guide develops concepts to reflect how
Manufacturing Practice (cGMP), FDA Draft Guidance for
these changes affect biopharmaceutical facilities without
Industry PAT Framework for Innovative Pharmaceutical
sacrificing product quality, by reducing risk and enhancing the
Manufacturing and Quality Assurance and much more. manufacturing control strategy. The Guide provides examples
BONUS: Receive the white paper, A Risk-Based of how these concepts can be put into practice, and details
the value and benefits of the approach described.
Approach to Defining Levels of Protection within API Facility
Design: the Concept of Briefly Exposed (Briefly Open), which
June 2007 expands and clarifies a new concept introduced in the Guide. December 2013 Bound Item #: IGBIOMF Bound or PDF Download
Pages: 188 Pages: 140 Pricing:
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Member $200/195
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Commissioning and Qualification Oral Solid Dosage Forms (Second

This Guide focuses on engineering approaches and practices Edition)
for timely, cost-effective delivery of manufacturing facilities, This revision updates content from the original Guide to
specifically addressing the process of designing, constructing, current industry standards, practices and regulatory require-
commissioning and qualifying the facilities, utilities and ments.
equipment regulated by the FDA or other health authorities.

2016
Specifically, it addresses the latest interpretation of GMP
It is intended primarily for regulatory compliance in the US requirements, as well as a risk-based approach to regulatory

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market, and it may be helpful to manufacturers for meeting
compliance relating to the design, construction and valida-
European requirements.
tion of the OSD manufacturing facility. The Guide provides a
Also included with the Guide is Appendix 2 from the ISPE comprehensive view of best practices available in the phar-
Guide: Science and Risk-Based Approach for the Delivery maceutical industry for oral solid manufacturing facility design
of Facilities, Systems, and Equipment to further assist and construction. A lifecycle approach to project manage-
ment is emphasized.

ISPE Publications Catalog

companies in transitioning from traditional impact assessment
March 2001 based approaches to ICH Q9, QRM approaches. November 2009
Pages: 142 Pages: 188
Bound or PDF Download Bound Item #: OSD1109 Bound or PDF Download
Bound Item #: CQ0101
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 Risk-Based Manufacture of Sterile Product Manufacturing
Pharmaceutical Products (Risk-MaPP) Facilities (Second Edition)
Risk-MaPP provides a scientific risk-based approach based This revised Guide contains recommendations to help
on ICH Q9 to manage the risk of cross-contamination to facilitate compliance with the latest FDA and EMA guidance,
maintain product quality and operator safety. incorporating a comprehensive tabulation, explanation and
comparison of the cleanliness designations found in FDA,
This Guide provides a process that allows manufacturers
EMA and ISO guidance documents, allowing for better
to assess risk and determine where control strategies are
harmonization in global facility design and a wider breadth of
necessary to meet acceptable limits for cross-contamination.
regulatory compliance internationally.
The control strategies to manage risk can vary from
administrative to full dedication or segregation. Typically,
Technical updates contained in the Guide include the use of
some combination of control strategies may be necessary.
RABS and isolator technology; facility design; best practices for
terminally sterilized and aseptically processed sterile products;
Individual PDF Download Pricing: and updated guidance on quality attributes of construction and
September 2010
Pages: 152
Item #: RISK0910DL Member $200/195 September 2011 finishes solutions for different grades of facility.
New Member* $484/433 Pages: 204
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Multiple Electronic Bound Item #: STER0911 Bound or PDF Download
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Water and Steam Systems (Second

Edition)
The revised Water 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
2016

that meet current Good Manufacturing Practices (cGMPs)

and comply with existing regulations and related guidance.
New chapters covering microbiological considerations, such
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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 has been reviewed by the US FDA and their

ISPE Publications Catalog

December 2011 comments have been taken into consideration in the final
Pages: 264 pages version of the Guide.

Bound Item #: WAT1211 Bound or PDF Download

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

GAMP Guidance Documents

GAMP 5: A Risk-Based Approach to A Risk-Based Approach to Calibration

Compliant GxP Computerized Systems Management (Second Edition)
GAMP 5 provides pragmatic and practical industry guidance Calibration Management (Second Edition) provides guidance
that aims to achieve compliant computerized systems that are in setting up a calibration management system, which will
fit for intended use in an efficient and effective manner, while give a structured approach to instrument risk assessment,
also enabling innovation and technological advance. The revised calibration program management, documentation and
Guide describes a flexible risk-based approach to compliant GxP corrective actions, essential to regulatory compliance.
regulated computerized systems, based on scalable specification
and verification. A robust quality risk management process The Guide has been updated to address the changing
based on ICH Q9 principles is central to the approach. GAMP environment, while still satisfying international GxP regulatory
5 also contains new information on outsourcing, electronic batch expectations, current at time of publication. The scope has
recording, end user applications, and patch management. been widened to include related industries, laboratory and
analytical instrumentation.
BONUS: Download of supporting materials, including
February 2008 key diagrams, templates, forms, example documents and
November 2010 Bound Item #: Bound or PDF Download
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A Risk-Based Approach to Compliant A Risk-Based Approach to GxP

Electronic Records and Signatures Compliant Laboratory Computerized
Accuracy and integrity of records and data is essential Systems (Second Edition)
throughout the product life cycle, from research and A Risk-Based Approach to GxP Compliant Laboratory
development through pre-clinical studies, clinical trials, Computerized Systems (Second Edition) contains steps

2016
production and quality control to marketing. This Guide that scientists, suppliers and others involved in managing
provides further guidance on this topic, and should be laboratory computerized system acquisition, implementation
read in conjunction with GAMP 5. This Guide provides and operations can use to verify laboratory systems are fit

WE HAVE ANSWERS.
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comprehensive guidance on meeting current regulatory for their intended use. Recently updated to conform with
expectations for compliant electronic records and signatures, concepts and terminology in GAMP 5, the Guide provides a
emphasizing well-documented, validated systems and the practical, risk-based approach for evaluating these systems,
application of appropriate operational controls. The Guide thus eliminating trial and error. By following the principles
applies a risk-based approach to implementation. outlined in the Guide, companies can save time and money,
improve communication with external parties and achieve

ISPE Publications Catalog

February 2005 October 2012 higher quality, better performing systems.
Pages: 240 Individual PDF Download PDF Download Pricing: Pages: 160
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* New Member fee includes one-year membership in ISPE a $284/238 value. See order form for details. 5
 A Risk-Based Approach to GxP A Risk-Based Approach to Operation
Process Control Systems (Second of GxP Computerized Systems, A
Edition) Companion Volume to GAMP 5
A Risk-Based Approach to GxP Process Control Systems This Guide highlights the importance of the operation phase
applies science-based quality risk management, as described of the system lifecycle, when the return on investment for
in ICH Q9 and GAMP 5. It describes the system life cycle the significant time and resource expended in implementing
from concept to retirement, providing a high level overview new computerized systems can be achieved. The Guide will
of the approach together with guidance on how activities help regulated organizations achieve regulated computerized
might be scaled based on risk to product quality, system systems that are fit for intended use and compliant with
novelty and complexity, as well as, other project specific applicable regulations and provides comprehensive guidance
factors. The Guide aims to achieve process control systems for maintaining control of regulated systems throughout their
that are fit for intended use and compliant with applicable operational life.
regulations; providing recommended good practice based on
When applied as intended, this Guide can provide detailed
a life cycle approach for the development, maintenance and
February 2011 January 2010 direction on the required control processes which form
management of process control systems. Pages: 216
Pages: 196 a substantial part of an appropriate Quality Management
System (QMS).
Bound Item #: GGPGPCS2 Bound or PDF Download
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A Risk-Based Approach to Regulated A Risk-Based Approach to Testing of

Mobile Applications
Mobile devices present a significant challenge to control,
and the possibility of putting regulated applications,
some of which may be classified as medical devices,
2016
GxP Systems (Second Edition)
This Guide helps the reader to maximize testing efficiency
without compromising the quality of GxP systems by focusing
testing on areas that have the greatest impact and eliminating

into the pockets of the public is new ground for the
industry. This new Good Practice Guide is intended to
provide a risk-based approach to implementing and
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duplicate testing. It was recently expanded and updated to
conform to GAMP 5 standards and terminology and reflect
ICH Q8, Q9 and Q10, quality by design and process analytical

supporting regulated mobile apps, and will be of value to
both regulated organizations and mobile app suppliers.
It focuses on the unique and specific issues related to
mobile apps and provides comprehensive guidance
for maintaining compliance and control throughout the
lifecycle by applying GAMP principle.
ISPE Publications Catalog
technology principles. This updated Guide contains new
information on cloud computing, automated testing and non-
linear development and focuses on risk-based approaches
that help suppliers to optimize their products and end-users to
focus on critical areas.

December 2012
Bound Item #: Bound or PDF Download
October 2014 Pages: 276
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6 To order, visit www.ISPE.org/Store.

 Electronic Data Archiving Global Information Systems Control
Electronic Data Archiving seeks to provide a rational and and Compliance
scaleable approach to electronic data archiving through the This Guide provides an understanding of the issues faced by
development of an archiving strategy. The implementation of teams that are tasked with completing a global deployment
this strategy should help organizations achieve and maintain of an IT system, in particular, to provide some insight into
regulatory compliance, and to effectively manage electronic addressing issues of control and regulatory compliance
records over the long term. efficiently and effectively. The Guide encompasses a wide
range of regulations and guidelines, including US FDA
This Guide is intended as a supplement to GAMP 5 and regulations and GPGs, relevant sections of EU GMPs,
should be read in conjunction with the GAMP Good Practice PIC/S Guidance, Health Canada GMP regulations and ICH
Guide: Electronic Records and Signatures, which provide Guidelines.
additional relevant information.
Bound Item #: 4GIS Bound or PDF Download
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IT Infrastructure Control and Manufacturing Execution Systems A

Compliance Strategic and Program Management
Approach
IT Infrastructure Control and Compliance provides
comprehensive guidance on meeting current regulatory The Guide uses a complete lifecycle approach to
expectations for compliant IT Infrastructure platforms, the development and use of MES for regulated

2016
including the need to identify, qualify and control those manufacturing as a collection or domain of
aspects impacted by GxP. manufacturing related functions that integrates business
and process controls, information flow and human

Bound Item #: 4IT
Individual PDF Download
Item #: 4ITDL
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interaction to facilitate the operation of an organization.
Bound or PDF Download It collects and integrates information and knowledge
Pricing: from many disciplines and sources into a single
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ISPE Publications Catalog

September 2005 February 2010 Bound Item #: GGPGMES Bound or PDF Download
Pages: 128 Pages: 144 Pricing:
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 ISPE Guides, Good Practice Guides and Handbooks
Applied Risk Management for Approaches to Commissioning and
Commissioning and Qualification Qualification of Pharmaceutical
Applied Risk Management for Commissioning and Water and Steam Systems (Second
Qualification describes how organizations can move from Edition)
established baseline practice to a more efficient science- Approaches to Commissioning and Qualification of
and risk-based framework. It illustrates the application Pharmaceutical Water and Steam Systems (Second
of quality risk management to traditional commissioning Edition) discusses practices and activities associated
and qualification practices, linking traditional terminology with the commissioning and qualification (verification) of
and approaches to the newer science- and risk-based pharmaceutical water and steam systems. The Guide
specification and verification terminology and approaches focuses on items which directly affect quality attributes
applied in ICH Q8, Q9 and Q10, ASTM E2500, and ISPE of water or steam during production, storage, and
Guide: Science and Risk-Based Approach for the Delivery of distribution. Both high purity water and pure (clean)
Facilities, Systems and Equipment. steam are considered and information on other types of
Date: June 2015
pharmaceutical water and steam is also provided.
October 2011 Bound or PDF Download
Bound Item #: IGPGARMCQ Pages: 120
Pages: 140
Pricing: Bound or PDF Download
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Assessing the Particulate Containment Biopharmaceutical Process

Performance of Pharmaceutical Development and Manufacturing
Equipment (Second Edition) This Guide intends to present a universal roadmap
Assessing the Particulate Containment Performance of for process development and manufacturing of
Pharmaceutical Equipment (Second Edition) has been biopharmaceuticals that provides practical, scientifically
updated to address a broader selection of containment sound guidance that helps users incorporate good practice
and insight in order to develop robust processes that produce
2016

technologies and processing equipment. It will provide

technical guidance and consistent methodologies for safe and more cost effective biopharmaceuticals.
evaluating the particulate containment performance
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(particulate emissions) of pharmaceutical equipment and
systems.
Specifically, the Guide provides a methodology to derive data
associated with handling of pharmaceutical ingredients that is
useful in the assessment of potential risks.
ISPE Publications Catalog
This Guide applies to the class of products that include
protein therapeutics, monoclonal antibodies, and/or those
cells or organisms that have been generated or modified by
recombinant DNA/RNA, or other technologies to produce
drug substance
October 2013

May 2012
Pages: 228 pages
Pages: 104 Bound Item #: IGBIOPDM Bound or PDF Download
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8 To order, visit www.ISPE.org/Store.

 Booklet Labels Clinical Supply Systems
This Guide was written to create methods for standardizing Clinical Supply Systems provides a detailed discussion
the format, design and content of clinical trial booklet labels. of important areas of clinical supply system functionality,
Because booklet labels contain vital information for testing touching on key business requirements to assist interested
sites and subjects, the Guide enables more consistent use of parties with developing customized clinical supply
booklet labels to reduce confusion and non-compliance. applications or assessing commercial off the shelf systems for
implementation. Examples and requirements for interfacing
In addition to suggestions for effective and compliant booklet clinical supply systems involved in the management of IMPs
label design, the Guide includes recommendations and with other internal or external systems are provided.
justification for placement of required information and whether
it should be included on the label or elsewhere. The Guide also contains a list of proposed standard data
terminology, along with frequently used equivalent terms,
Individual PDF Download definitions of the data terms, and data formatting standards.
PDF Download Pricing:
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March 2015
Pages: 42 New Member* $383/333 Individual PDF Download PDF Download Pricing:
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Version Only Version Only

Cold Chain Management Comparator Management

This Guide provides tools and strategies for cold chain Comparator Management has been developed to use as
management and to complement work by the guidance a central reference source that establishes strategic and
for Temperature Controlled Medicinal Products. It helps tactical considerations related to comparator sourcing. It
to develop, establish, document, implement, maintain identifies good practices for making sourcing decisions,
and improve industry good practice for product requiring including how to set up a good sourcing team. The Guide
controlled cold conditions. The Guide is intended to provide also discusses good practices for blinding and releasing a

2016
practical guidance to assist in the specification, design, comparator for use.
commissioning and verification of the fixed and passive

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systems within the cold chain. The Guide will also explain the risks involved with ineffective
comparator methods, and provide companies with
The Guide covers the process from the point of entry into strategies for avoiding the costs, delays and potential case
the manufacturers controlled temperature storage facility study inaccuracies that might result from faulty comparator
after being packaged through delivery to the distributor or management.
customer premises. March 2012

ISPE Publications Catalog

May 2011
Pages: 140
Bound Item #: IGPGCCM
Individual PDF Download
Item #: IGPGCCMDL
Pages: 84
Bound Item #: IGPGCMGMT Bound or PDF Download
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 Development of Investigational Good Engineering Practice
Therapeutic Biological Products Good Engineering Practices (GEPs) consist of proven and
This Guide will consider the major issues that will confront a accepted engineering methods, procedures and practices
biopharmaceutical company in moving therapeutic biological that provide appropriate, cost-effective and well-documented
products from the laboratory to the clinic and beyond. The solutions to meet user-requirements and compliance with
Guide is intended to provide readers with an understanding applicable regulations. GEP underpins activities in the day-
of issues surrounding product and process development, to-day operations and forward planning of a pharmaceutical
manufacturing, investigational product supply chain business. The adoption of this methodology leads to
management, quality control/quality assurance and global a balance of expenditure and activity. In addition, GEP
regulatory requirements for biopharmaceuticals. documentation can be leveraged to support verification
work. This Guide brings a wealth of information on GEPs and
Bound or PDF Download
provides benchmarking tools of current company practices
Bound Item #: IGPGBIOL
against what is considered industry good practice.
Pricing:
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Languages

Harmonizing the Definition and Use Heating, Ventilation, and Air

of Non-Investigational Medicinal
Products (NIMPs)
Harmonizing the Definition and Use of Non-Investigational
Medicinal Products (NIMPs) aims to provide practical
operational guidance and drive a consistent industry
2016
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 HVAC Guide
provides designers and the project team with suggestions to
help determine the user requirements and the functional design

approach to the use of NIMPs. The Guide contains criteria for

classifying NIMPs and an overview of current NIMP regulatory that define the facilitys objectives. It also provides options to be
requirements. considered in creating a design that has low lifecycle cost and
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that is sustainable.
This Guide will provide guidance on sourcing strategies,
packaging and labeling approaches, storage and distribution
recommendations, regulations categorized by region/ Bound Item #: IGPGHVAC Bound or PDF Download
country, approaches to management of drug accountability, Pricing:
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traceability, complaints and recalls with reference to the
ISPE Publications Catalog

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Pages: 56
NIMPs and comparators.

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 Interactive Response Technology Maintenance
Interactive response technology is a tool that can be used to This Guide provides practical solutions and tools for ensuring
support multiple business processes, and this Guide describes quality and compliance of maintenance operations in a
how the pharmaceutical industry can apply the technology to regulated industry. Covering current and established practices,
support various clinical trial activities. this Guide helps achieve technical and regulatory accuracy and
cost-effective compliance in a new or existing maintenance
The Guide provides guidance on how to successfully program for effective strategy and efficiency. Offering
implement an interactive response technology to manage maximum flexibility, this Guide helps to clearly define roles and
key clinical trial activities, particularly expiry date management responsibilities across cross-functional areas and recommends
and program pooling; ensure robustness of the technology, a systematic approach aimed at continuous improvement of
contributing to its effectiveness and reliability; and communicate maintenance operations.
and foster a standardized, industry-wide approach to critical
functionality of Interactive Response Technology when used in
managing investigational medicinal product. Bound Item #: IGPGMAINT Bound or PDF Download
November 2011 Pricing:
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Ozone Sanitization of Pharmaceutical

Water Systems Packaging, Labeling, and
Ozone Sanitization of Pharmaceutical Water Systems Warehousing (PACLAW) Facilities
provides an overview of ozone sanitization systems, including The PACLAW Guide helps companies avoid product
regulatory considerations and other factors companies adulteration, product mix-up, label mix-up and misbranding
should take into account when deciding to use ozone vs. by presenting an approach to satisfying CGMPs while
other sanitization approaches. It discusses specific system

2016
providing realistic solutions to business and operational
requirements, as well as associated advantages and concerns. It addresses quality by design principles and
disadvantages of using ozone as a water sanitization method. establishes consistent guidelines that can be incorporated

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into the design and/or reconfiguration of PACLAW facilities.
The Guide helps companies better understand what ozone
It covers facility design issues for most primary packaging
systems are, why they can be a safer, more efficient and
more cost-effective way to sanitize pharmaceutical water, and operations, such as filling of the dosage form in the
how they can be incorporated into both new and retrofitted immediate container/closure system, and other packaging,
facilities. labeling and warehousing processes. The Guide also
July 2012 provides direction on how to comply with the FDAs systems-

ISPE Publications Catalog

Pages: 144
Bound Item #: IGPGOZONE
Individual PDF Download
Item #: IGPGOZONEDL
June 2012
Pages: 112
based approach with a risk-based inspectional model as it
Bound or PDF Download relates to PACLAW facilities.
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 Process Gases
Project Management for the
Process Gases aims to define current good practices within
pharmaceutical manufacturing applications, providing Pharmaceutical Industry
information to allow organizations to benchmark their Project Management for the Pharmaceutical Industry provides
practices and improve upon them. good practice approaches which promote the successful
integration of GxP with relevant project management activities
The Guide focuses on defining cost effective engineering to ensure that compliance risk is managed effectively and
approaches and practices used to deliver a process gas proactively.
systems for a manufacturing facility in a timely manner that
will meet its intended purpose. Information is provided on The Guide discusses: the tools and techniques supporting
how to avoid increasing facility installation and operational project delivery, the life cycle of a typical project in
costs. Specifically, the Guide addresses the process of the pharmaceutical industry and how compliance to
designing, constructing, commissioning and qualifying a pharmaceutical industry regulations is integrated with the
process gas system regulated by the FDA or other regulatory project life cycle.
July 2011 authority, such as the EMA.
Pages: 148 November 2011
Bound Item #: IGPGPM Bound or PDF Download
Bound or PDF Download Pages: 282
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Quality Laboratory Facilities Science and Risk-Based Approach

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
2016
for the Delivery of Facilities, Systems,
and Equipment
This Guide provides direction to industry on the
implementation of a science- and risk-based approach for
demonstrating that pharmaceutical and biopharmaceutical

of producing a quality lab and all the factors that must be facilities, systems, equipment and associated automation are
considered at each phase. fit for intended use and comply with regulatory requirements.
WE HAVE ANSWERS.
YOU HAVE QUESTIONS.

The Guide helps save time and money by facilitating effective The aim of the Guide is to facilitate the translation of the
communication between lab owners, engineers and builders scientific knowledge about the product and process into
about the function, operation and design parameters that documented specification, design and verification of facilities,
must be met. systems and equipment. Specific implementation guidance is
given on meeting the expectations of global regulators and is
June 2011
ISPE Publications Catalog

Bound or PDF Download compatible with ICH documents (Q8(R2), Q9 and Q10) and
September 2012 Bound Item #: IGPGQLF Pages: 120 pages ASTM E2500-07.
Pages: 176 Pricing:
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12 To order, visit www.ISPE.org/Store.

 Sustainability Handbook Technology Transfer (Second Edition)
ISPEs first handbook is written to provide information at the Technology Transfer has been revised to align with
front end of projects that will be useful to the project team concepts and terminology used in industry and regulatory
in understanding sustainability criteria, with examples where developments. The Guide discusses the critically important
considered useful. It is based on the premise that there is area of the transfer of knowledge as a key part of technology
a viable path to achieving sustainability that corresponds transfer and as a component of the overall life cycle
to all of the precepts of the life sciences industry. This is an knowledge management process
especially important ethical consideration for the healthcare
industry, which has a focus centered on maintaining or The Guide also presents industry good practices for
improving the health of the patient. successful and efficient execution of technology transfer
projects and to achieve a balance between risk management
Individual PDF Download and cost effectiveness while aligning with applicable
PDF Download Pricing:
regulatory expectations.
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December 2015 New Member* $429/378 May 2015
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Investigational Product Resources

2016WE HAVE ANSWERS.

YOU HAVE QUESTIONS.
Comprehensive Guide to Clinical Materials
A Handbook for Training Clinical Materials Professionals
Introductory US Clinical Trial Materials Training Guide

ISPE Publications Catalog

Investigational Materials Sample Retention Guide

See www.ISPE.org/Publications/Investigational-Products for details

* New Member fee includes one-year membership in ISPE a $284/238 value. See order form for details. 13
 ISPE PQLI

Guides
Part 1 Product Realization using Part 2 Product Realization using
QbD: Concepts and Principles QbD: Illustrative Example
Part 1 includes the topics of criticality, design space and Part 2 of the ISPE PQLI Guides Series presents the small
control strategy and addresses product and process molecule case study developed by the ISPE PQLI teams.
development, transfer to and establishment of, commercial This case study provides details of the application of the
manufacture using science- and risk-based approaches. approaches to product and process understanding using
quality risk management.
Bound Item #: PQLI1 Bound or PDF Download
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November 2011
Pages: 188 November 2011
Pages: 232

Multiple Multiple
Languages Languages

Part 3 Change Management System Part 4 Process Performance and

as a Key Element of a Pharmaceutical Product Quality Monitoring System
Quality System (PP&PQMS)
Part 3 of the ISPE PQLI Guide Series provides practical, real- Part 4 serves as practical how-to guidance with examples
world strategies for implementing the change management of technical and scientific methodology for adopting a
2016

recommendations of ICH Q10 and contains information to
help translate the holistic approach described in Q10 into an
actionable plan and can help companies update and improve
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YOU HAVE QUESTIONS.
Process Performance and Product Quality Monitoring
System (PP&PQMS) in line with the expectations of ICH Q10,
Pharmaceutical Quality System.

their change management practices.

Individual PDF Download PDF Download Pricing:

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ISPE Publications Catalog

New Member* $383/333 Nonmember $405/350

June 2012 Nonmember $405/350 June 2013
Pages: 56 Pages: 80

Electronic Electronic
Version Only Version Only

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

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