GRUPO TERRA FARMA, DISTRIBUYE PUBLICACIONES DE supervisors, regulatory and compliance personnel, validation

LA PDA (PARENTERAL DRUG ASSOCIATION). specialists and professionals engaged in other aspects of
pharmaceutical and biopharmaceutical manufacturing.
Ponemos a su disposición los siguientes títulos de su interés, a Date of Publication: Dec 2008 ISBN Number: 1-933722-27-4
precios preferenciales y descuentos en la compra de 5 libros o más: Number of Pages: 536 PDA Item No: Hardcover: 17268

Assuring Data Integrity for Life Sciences (Hardcover)

(H0626) Biotechnology: From Idea to Market (Hardcover) (H0571)
Editor. Siegfried Schmitt Edited by Fred Mermelstein, Carl Novina, Richard Prince
This new book provides a truly global perspective on data integrity PDA's latest professional resource, Biotechnology: From Idea to
and the solutions available to address this serious issue. It includes Market, is an invaluable guide and reference for anyone involved in
two main sections: the regulatory and historic background of data the development of a product, from idea generation through
integrity, and practical advice on how to prevent or rectify data commercialization.
integrity breaches. The goal of this book is to provide this comprehensive overview for
Each chapter is written by renowned, highly experience subject students and professionals alike in how to think about and to
matter experts in the fields of compliance and data integrity and navigate the necessary development process for healthcare product
includes a "how to" section with practical, implementable advice. candidates, including biologics, new chemical entities, and other
Content is up to date with the latest regulations and guidances, related products that address medical need. This instructional text
making this the most relevant reference source of its kind. Useful enables anyone at any level or in any sector of the industry to easily
checklists and aide memoirs can be customized by the discerning achieve a basic knowledge of the critical steps (or the questions to
reader. This book should be equally useful for the quality unit ask) to properly evaluate an idea or technology, develop a viable
professional, operations manager, validation experts and regulators. product candidate, and ultimately advance it to the marketplace.
The modular structure allows readers to pick chapters of special Expertly conceived and crafted by co-editors Fred Mermelstein,
interest without having to reach the chapters in order. However, Richard Prince, and Carl Novina, with a foreword by Nobel Laureate
given the usefulness and universal application the "nuggets of Philip Sharp, this book features 22 chapters written by renowned
wisdom" and advice provided, it is anticipated that readers will want subject matter experts in their respective fields. Collectively, these
to read the publication in its entirety. chapters illuminate and unify the healthcare products innovation
Date of Publication: Mar 2016 ISBN Number: 1933722975 process, spanning from academia to industry, from research to
Number of Pages: 408 PDA Item No: Hardcover: 17335 commercialization. Chapters are organized into five sections:
• Section 1: Due Diligence (Chapters 1-6)
Audit and Control for Healthcare Manufacturers: A Systems- • Section 2: Financing (Chapters 7-9)
Based Approach (Hardcover) (H0579) • Section 3: Operationalization (Chapters 10-16)
• Section 4: Legal (Chapters 17-19)
By Jennifer Sandle, Tim Sandle
• Section 5: Commercialization (Chapters 20-22)
Audits are an important part of quality assurance and the quality
Gain a more integrative understanding of product development
management system. With the help of PDA's newest book, Audit
and commercialization and get all the information you need to
and Control for Healthcare Manufacturers: A Systems-Based
become a successful biotechnology entrepreneur!
Approach, you can ensure the quality and effectiveness of your
Date of Publication: Aug 2019 ISBN Number: 9781942911371
processes, systems, and personnel is maintained throughout your
Number of Pages: 1064 PDA Item No: Hardcover: 17352
organization!.
Date of Publication: Apr 2019 ISBN Number: 9781942911364
Cleaning Validation: Practical Compliance Solutions for
Number of Pages: 862 PDA Item No: Hardcover: 17351
Pharmaceutical Manufacturing, Volume 3 (Hardcover)
(H0639)
Biological Indicators for Sterilization Processes (Hardcover)
Author: Destin LeBlanc
(H0673)
In Destin LeBlanc's Cleaning Validation: Practical Compliance
By: Margarita Gómez
Solutions for Pharmaceutical Manufacturing, Vol. 3 pharmaceutical
This book discusses the basic concepts necessary to the manufacturers and upper management are encouraged to meet the
understanding of Biological Indicators and includes the history of challenges of the science-based and risk-based approaches to
biological validation and general principles, the kinetics of microbial cleaning validation.
inactivation and factors affecting resistance as well as guidance in
understanding bacterial endospores due to their high resistance to
Volume 3, a complement to Destin's two earlier books on the same
most inactivation process they are commonly used to challenge the
subject, presents modifications and updates of his monthly Cleaning
process. Different perspectives on the use of BIs are explained as is
Memos originally published from January 2009 through December
validation and monitoring of sterilization processes in the US,
2012. Each Cleaning Memo is presented as a chapter, with the
Europe and Japan as are the various references and standards
chapters then organized by common topics. For example, topics
available worldwide. This book will be of great interest to laboratory
related to setting limits are in one section, those related to sampling
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in another section, and so forth. An appendix with a list of acronyms This book is quite different from the typical prescriptive PDA/DHI
is included as well. "how-to" publication. Noted pharmaceutical cold-chain expert, Kevin
Date of Publication: May 2017 ISBN Number: 1933722681 O'Donnell, relates a series of engaging stories carefully crafted to
Number of Pages: 251 PDA Item No: Hardcover: 17310 elevate awareness, understanding, and criticality of temperature-
sensitive drug products throughout the supply chain — not only for
Cleanroom Contamination Prevention & Control: A Practical the stakeholders involved — but for the consumer in us all.
Guide to the Science (Hardcover) (H0637) O'Donnell deftly blends his cold-chain storytelling with charm and
wit, history and science, and the wisdom of a practitioner's 35 years'
By: Ziva Abraham / Morgan Polen
experience. These thought-provoking narratives convey to the
This timely and informative text discusses aspects of contamination
reader heuristic lessons that underscore the risks involved and the
control in cleanrooms seldom described in detail in the literature.
impending need to improve the processes that ensure these fragile
The increasing number of warning letters, product recalls and 483
pharmaceutical products arrive to their destinations — and to the
observations related to both particulate and microbial contamination
patients who need them — in a safe, controlled way.
indicates that contamination control principles need to be better
As an added bonus for both new and experienced colleagues, the
understood from both a practical and scientific perspective to the
World Health Organization has granted permission allowing readers
global regulations that controls these environments. to access, either by URL or QR codes available in the book, training
This text covers risk-based approaches to a cleaning and disinfection videos they have prepared on the subject.
program and case studies in contamination control. It provides
Date of Publication: Jan 2015 ISBN Number: 1933722827
details on safe building techniques for new cleanrooms and
Number of Pages: 184 PDA Item No: Hardcover: 17323
modifications of existing areas by providing a risk-based approach
for cleaning and disinfection using good science. It also discusses
the dangers of outdated cleanroom and barrier systems designs, Computerized Systems in the Modern Laboratory: A
and that limited understanding of the real airflows has led to repeat Practical Guide (H0625)
contamination related observations worldwide. Case study by: Joseph Liscouski
examinations discuss the most common causes of contamination The Bio/Pharmaceutical industry is at an interesting crossroads
and many useful solutions on how to proactively prevent recurring regarding the use of electronic technologies in laboratories.
contamination are presented. Laboratory management and staff must often evaluate tools that
they don't completely understand, while facing pressure from
Not mitigating contamination possibilities leads to cleanrooms and
vendors trying to make a sale. Furthermore, regulatory agencies are
barrier systems which are unsuitable for the manufacture of sterile
requiring senior management to justify the application of scientific
products and pose a risk to product and patient. This text provides
electronic technology. Computerized Systems in the Modern
the help readers need.
Laboratory will provide laboratory staff and managers a solid
Date of Publication: Feb 2021 ISBN Number: 9781942911548
understanding of the tools available, how to successfully purchase
Number of Pages: 486 PDA Item No: Hardcover: 17360 and implement the technology, and how to develop a plan for
application and evaluation in order to meet regulatory requirements.
Date of Publication: Mar 2015 ISBN Number: 193372286X
Cleanroom Microbiology (Hardcover) (H0582) Number of Pages: 434 PDA Item No: Hardcover: 17329.
Author: Tim Sandle, R. Vijayakumar
While there are books on cleanrooms available, these focus almost Conducting Compliant Investigations (Hardcover) (H0640)
entirely on the physical and rarely address microbiological risks. By: Jeanne Moldenhauer
Similarly, there are various books on microbiology (even a few about In this book you will find many different approaches to conducting
pharmaceutical microbiology), yet these books rarely mention compliant investigations, where compliant is defined as meeting the
cleanrooms, or, where they do, give controlled environments limited requirements of the applicable regulatory documents.
coverage. The information it provides on conducting investigations that will be
To the authors of Cleanroom Microbiology, these two domains, acceptable to regulatory investigators will be instrumental in helping
normally separated by different functions, are inseparable. This you to significantly reduce regulatory risk.
book is about cleanrooms and controlled environments in relation to Date of Publication: Mar 2021 ISBN Number: 9781942911579
the pharmaceutical and healthcare sectors and is applicable to both Number of Pages: 504 PDA Item No: Hardcover: 17363
the sterile and non-sterile pharmaceutical sectors with its focus on
cleanroom microbiology.
Date of Publication: Jan 2015 ISBN Number: 1933722843 Contamination Control in Healthcare Product
Number of Pages: 588 PDA Item No: Hardcover: 17326 Manufacturing, Volume 5 (Hardcover) (H0650)
Edited by: Russell Madsen, Jeanne Moldenhauer.
Cold Chain Chronicles: A practitioners outside-the-box The fifth volume to PDA's popular series, Contamination Control in
perspectives on the importance of temperature-sensitive Healthcare Product Manufacturing, explores practical approaches to
drug stewardship (H0583) leverage environmental monitoring data to improve performance,
Author: Kevin O`Donnell how to design a risk-based environmental monitoring program for
non-sterile manufacturing, the clinical relevance of objectional

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microorganisms, and much more! Edited by global subject matter currently stand, where they are likely to develop, and the challenges
experts, the fifth volume of PDA's Contamination Control series that digital technology adopters face, in terms of practicalities and
includes valuable updated information on a variety of contamination in maintaining GMP compliance.
control topics such as: Contamination control strategies, Low Date of Publication: Jan 2021 ISBN Number: 9781942911531
Endotoxin Recovery (LER), Environmental monitoring, Regulatory Number of Pages: 420 PDA Item No: Hardcover: 17362
expectations, Contamination control in the real world.
Date of Publication: 2018. Number of Pages: 510. ISBN Digital Transformation and Regulatory Considerations for
Number: 9781942911326. Hardcover: 17350. Biopharmaceutical and Healthcare Manufacturers: Digital
Technologies for Automation and Process Improvement
(Hardcover) (H0743)
By: Tim Sandle
Confronting Variability: A Framework for Risk Assessment This first-of-two volume release from prolific author Tim Sandle fills
(Hardcover) (H0741) an important void by taking an in-depth look at the way digital
By: Richard Prince technologies are impacting the pharmaceutical and healthcare
Variability is more than just the ‘noise in the system.’ It represents landscape both now and into the future. He explores how companies
an insidious threat to companies, ranging from the reliability of their have been embracing digital technologies as part of the
product lines to the strength of their financial bottom-lines. The transformation of their business models.
understanding of variability sources, therefore, can provide a solid The disruption caused by the digital transformation of
framework for risk assessment and an estimation of the impact pharmaceuticals and healthcare is not static; it is evolving, and it
these risks pose. will continue to evolve. Across the informative and substantive
This book examines those elements of variability as they relate to chapters, this book takes stock of the current technological
people, processes, manufacturing systems, non-manufacturing landscape, where it is likely to develop, and the challenges that
systems, quality systems, laboratory systems, supply chains and adopters face, in terms of practicalities and in maintaining GMP
GMP codes related to the pharmaceutical industry. It provides a new compliance. It explores what each technology does, the potential
perspective on the meaning and relationship of variability in relation use of the technology, and the practical aspects for its
to work performed, as well as an insightful framework for the quality implementation.
assessment of risk in the pharmaceutical industry. Yet, digital transformation is not just about technology. The process
Date of Publication: Jan 2007 ISBN Number: 1-933722-04-5 also concerns changes to culture and structure, the understanding
Number of Pages: 222 PDA Item No: Hardcover: 17244 of which is presented in this book and is critical for those working in
the pharmaceutical sector.
The themes covered in this first volume are process-centric and
Digital Transformation and Regulatory Considerations for include blockchain and track and trace technology, fostering the
Biopharmaceutical and Healthcare Manufacturers, Volume digital pharmaceutical company, and building efficiencies through
2: Digital Data, Insights, Metrics and Analytics (Hardcover) real-time metrics and Process Analytical Technology. The second
(H0749) volume will address the digitization of the laboratory and a survey
By: Tim Sandle of data handling issues.
This second of two volumes details how pharmaceutical and Date of Publication: Oct 2020 ISBN Number: 9781942911524
healthcare manufacturers have ben embracing digital technologies Number of Pages: 378 PDA Item No: Hardcover: 17361
as part of the transformation of their business models. It
contextualizes current developments and future advancements in Effective Implementation of Audit Programs. (H0631)
terms of the COVID-19 situation of 2020 and specific measures that Editor. Miguel Montalvo
were taken. Written by Miguel Montalvo, who has more than 32 years of
Topics and laboratory functions that will be explored include: extensive experience in the areas of cGMP compliance, quality
• New model healthcare operations/systems and validation functions/responsibilities, this
book applies recent developments and perspectives from regulators
• Ways to use digital data, including root cause and industry experts.
investigations This well-researched text is a must have for personnel involved in
• Office technology the implementation and execution of critical programs, auditors,
• Protecting ownership security auditees and outsourcing providers!
• E-learning and virtual inspections Date of Publication: Feb 2017 ISBN Number: 9781942911036
Number of Pages: 390 PDA Item No: Hardcover: 17340
• And many more
The first volume of this two-part collection addresses building a
digital company, big data analytics, advances in Process Analytical
Technology electronic batch records, Block Chain, and more. Taken
together, these volumes provide a clear picture of where things

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Encyclopedia of Rapid Microbiol Methods, Volume 4 updates, testing methods, risk methods and tools, and routine (and
(Hardcover) (H0722) non-routine) monitoring.
By: Dr. Michael J. Miller Date of Publication: Aug 2017 ISBN Number: 9781942911135
Rapid microbiological methods have made amazing strides recently Number of Pages: 257 PDA Item No: Hardcover: 17343
and this volume complements Dr. Miller's previous three volumes by
offering up-to-the-minute advances, new techniques, case studies, Essential Microbiology for QP Candidates (Hardcover)
new equipment and much more. (H0729)
Contents of the Encyclopedia of Rapid Microbiological Methods, By: Nigel Halls
Volume 4 include details about: quality control, choosing This book has been prepared to address the requirements which are
appropriate methods, future use and technologies, mass stated in the Guide to the Knowledge and Practical Experience
spectrometry, genotypic methods for identification, new case Required by Qualified Persons in the Pharmaceutical Industry (the
studies, detection, application of USP and other guidelines, "Study Guide") in relation to pharmaceutical microbiology.
environmental monitoring, alternative tests, validation, sterility This reference guide will help QP candidates prepare for the
testing, mycoplasma testing, application of rapid microbiological assessment board, as well as refresh QPs who are faced with actual
methods as they relate to both bio-processing and regulatory or potential microbiology problems. This guide additionally serves
considerations, many product-specific method advances and much, as a useful starting point for QPs who may wish to explore
much more. pharmaceutical microbiology in greater depth than simply what is
Date of Publication: Mar 2015 ISBN Number: 1933722665 required by the Study Guide.
Number of Pages: 611 PDA Item No: Hardcover: 17308 Date of Publication: Sep 2007 ISBN Number: 1-933722-18-5
Number of Pages: 314 PDA Item No: Hardcover: 17265

Environmental Monitoring: A Comprehensive Handbook,

Volume 7 (Hardcover) (H0649) Fungi: A Handbook for Life Science Manufacturers and
Edited by Jeanne Moldenhauer Researchers (Hardcover) (H0647)
This is volume 7 of the Environmental Monitoring Handbook series. Edited By: Jeanne Moldenhauer
Each volume of this series discusses different aspects of This text can help identify and ameliorate fungal and mold problems
environmental monitoring. One of the first topics discussed in this and contains a wealth of information as a guide and reference. Many
volume is the topic of cleanrooms and ways to prevent topics are discussed relevant to the food and agriculture industries,
contamination. Subject matter experts Dr. Tim Sandle, Jan Eudy, including the biology of fungi, outbreaks associated with
Jim Polarine, John Lindsay and others describe new and/or better pharmaceutical drug products and medical devices, mycotoxins,
ways to do things. fungal biodegradation and remediation, and strategies for a rapid
The second section of the book describes various environmental and accurate fungal identification. The text also contains a lengthy
monitoring techniques and methods and includes informative fungal glossary.
chapters from Ryan Burke, Allan Marinelli, Dr. Andrew Sage, Tim Date of Publication: Dec 2019 ISBN Number: 9781942911401
Cser, Sean Toler, Claire Fritz Briglia and others. Number of Pages: 813 PDA Item No: 17355
The third section of the book deals with changes to standards.
Memarzadeh and DeBerandinis explain the changes that occurred FDA Warning Letters: Analysis and Guidance (Hardcover)
for ANSI Standard 29.14 and how this is applicable in (H0646)
pharmaceutical environments and the last section of this volume
By Jeanne Moldenhauer
talks about new technologies and aids that can be used in evaluating
The best way to handle Warning Letters issued by the U.S. FDA is
these methods with chapters from Dr. Sage and Dr. JP Jiang.
to prevent them. This text identifies and discusses those Letters
There is a wealth of useful information that you can use in
recently issued, offers analysis, and provides guidance to help
establishing, maintaining and updating your environmental
readers avoid receiving such a letter.
monitoring program!
In addition to the Warning Letter summaries there is discussion of
Date of Publication: Jan 2015 ISBN Number: 1933722851
U.S. FDA's authority to perform and approach to inspections, some
Number of Pages: 388 PDA Item No: 17325 analysis of the types of observations, and guidance on how to deal
with adverse findings if you have them.
Environmental Monitoring: A Comprehensive Handbook, As an added benefit, this text also includes instructions and
Volume 8 (Hardcover) (H0732) suggestions for those who were unable to avoid getting a warning
Editor. Jeanne Moldenhauer letter to help resolve matters as quickly as possible.
Volume 8 of the Environmental Monitoring Handbook series is a Date of Publication: Feb 2020 ISBN Number: 9781942911418
mixture of new topics and takes on previously discussed topics. In Number of Pages: 578 PDA Item No: Hardcover 17356
this volume, you will find information about regulatory/compendial

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GMP in Practice: Regulatory Expectations for the Date of Publication: Feb 2016 ISBN Number: 9780939459834
Pharmaceutical Industry, Fifth Edition, Revised and Number of Pages: 99 PDA Item No: Softcover: 03006.
Expanded (H0633)
Editor. James L. Vesper Good Distribution Practice: A Handbook for Healthcare
Have you ever asked yourself, "Where in the Good Manufacturing Manufacturers and Suppliers, Volume 1 (Hardcover)
Practices (GMPs) does it say I have to do _______?" If so, look no (H0572)
further than PDA's GMP in Practice: Regulatory Expectations for the Edited by Siegfried Schmitt
Pharmaceutical Industry, fifth edition, Revised and Expanded. Following an introduction to the subject of Good Distribution Practice
As companies strive to harmonize global requirements for quality (GDP), the first volume of this book covers key topics related to five
systems, the 5th edition of this text provides an overview of the 34 main points: the applicable GDP regulations worldwide, including
essential global cGMP requirements that are typically included in a serialization; an overview of the requirements of Qualified Persons
modern pharmaceutical quality system, including data integrity and and Responsible Persons in GDP; GDP as part of the Quality
how they have evolved. Explore risk-related questions, delve into Management System; an industry perspective on GDP; and a
several expectations for each quality system element encompasses, practical GDP checklist.
and review real-world examples from cGMP regulations from the US This text and its companion Volume 2 will help drive down costs and
FDA, Health Canada, the European Union, the World Health improve efficiency
Organization, and the International Conference on Harmonization
Date of Publication: Oct 2019 ISBN Number: 9781942911388
(ICH).
Number of Pages: 578 PDA Item No: Hardcover: 17353
If you're looking for an enhanced understanding of GMP in
practice, this text is a must-have for your reference collection.
Date of Publication: Jul 2018. Good Distribution Practice: A Handbook for Healthcare
Manufacturers and Suppliers, Volume 2. (H0709)
Good Distribution Practice: A Handbook for Healthcare Edited by Siegfried Schmitt
Manufacturers and Suppliers, Volume 1 (H0711) Following an introduction to the subject of Good Distribution Practice
By: Dr Siegfried Schmitt (GDP), in the second volume, dive into supply-chain risk mitigation,
serialization, and packaging as it relates to risk assessments.
Following an introduction to the subject of Good Distribution Practice
(GDP), the first volume of this book covers key topics related to five This text and its companion Volume 1 will help drive down costs and
main points: the applicable GDP regulations worldwide, including improve efficiency.
serialization; an overview of the requirements of Qualified Persons Date of Publication: Oct 2019 ISBN Number: 9781942911395
and Responsible Persons in GDP; GDP as part of the Quality Number of Pages: 420 PDA Item No: Hardcover: 17354
Management System; an industry perspective on GDP; and a
practical GDP checklist. Lifecycle Risk Management for Healthcare Products: From
This text and its companion Volume 2 will help drive down costs and Research Through Disposal (Hardcover) (H0634)
improve efficiency Editor. Edwin Bills, Stan Mastrangelo
Date of Publication: Sep 2019. Number of Pages: 295. ISBN This book provides current information on the risk management
Number: 9781942911388. PDA Item No: 17353 process as it applies to health and safety of health products, drugs
and biologics, medical devices and products that are a combination
of two or more of these. The application of the processes will help
Good Distribution Practice: A Handbook for Healthcare manufacturers of these products to create and maintain products
Manufacturers and Suppliers, Volume 2 (H0738) that are at an acceptable level of safety for society though the
By: Dr Siegfried Schmitt product lifecycle.
Following an introduction to the subject of Good Distribution Practice This book has been divided into two parts, part one covers
(GDP), in the second volume, dive into supply-chain risk mitigation, healthcare risk management processes and frameworks and part
serialization, and packaging as it relates to risk assessments. two covers special topics.
Date of Publication: Sep 2019. Number of Pages: 420. ISBN In the first part, the editors provide a historical perspective of the
Number: 9781942911395. PDA Item No: 17354 risk management framework as well as management and its
responsibilities for implementation of risk management in health
product companies. You will also find an overview of combination
products, use of risk traceability, criteria for risk acceptability and
Global Sterile Manufacturing Regulatory Guidance
production and post-product risk management in this section.
Comparison (Softcover) (H0470)
In the second part, specific applications of health product risk
Within the document, you will find analysis and comparison tables management are examined, including clinical trials, quality system
that are easy-to-use references for companies that need to adhere software and in vitro diagnostic devices.
to the four regulatory documents; the spreadsheet allows
Date of Publication: 2016. Number of Pages: 295. ISBN Number:
companies to do their own assessment of their status for each
19781942911012. PDA Item No: 17338.
element.

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Method Development and Validation for the Pharmaceutical identification knowledge as a cornerstone in the concept of microbial
Microbiologist (Hardcover) (H0635) and contamination control programs. This book is an excellent
Editor. Crystal Booth reference for new microbiologists and seasoned professionals alike.
The book primarily focuses on parenteral products and the Each chapter illustrates how microbial control programs for facilities,
excipients, but the methodology can transfer to other areas of equipment, and personnel can have a positive impact on products
microbiology as well. The book also provides advice on programs and ultimately, patients.
and special studies that might be performed in the pharmaceutical The three sections will focus on the following topics:
microbiology laboratory. • Strategies: Regulation, regulatory expectations, and strategies
The purpose of this book is to inspire ideas and provide for trending, risk assessments, and risk management.
recommendations regarding method development and validation
• Methods: Current best practices for microorganism
strategies for pharmaceutical microbiologists. The book may also aid
identification methods, both conventional and emerging rapid
microbiologists when starting new facilities or validating equipment.
methods for bacteria, viruses, mycoplasma, and fungi.
This is a must have resource for anyone engaged in the many
aspects of method development and validation in pharmaceutical • Applications: Microbiology laboratory training for identifications,
microbiology. use of environmental and control microorganisms, disinfectant
effectiveness and best practices, and biosafety for laboratories,
Date of publication: Feb 2017. Number of Pages: 406. ISBN:
manufacturing facilities, and personnel.
9781942911029. PDA Item No: 17339.
Date of Publication: May 2018 ISBN Number: 9781942911272
Number of Pages: 592 PDA Item No: Hardcover: 17347
Microbiological Culture Media: A Complete Guide for
Pharmaceutical and Healthcare Manufacturers (Hardcover)
(H0636)
Editor. Tim Sandie
Taking into account that 90 percent of quality control microbiology
remains reliant upon culturebased methods, this unique text focuses Microbial Risk and Investigations (H0712)
on microbiological culture media as applied to pharmaceutical Edited by: Jeanne Moldenhauer, Karen McCullough
microbiology. This book takes into consideration that innovations The Barr Decision (Barr, 1993) forever changed how pharmaceutical
continue to arise with new media recipes that are formulated for the companies look at data that is out-of-specification (OOS). Following
selection of new strains for the application of media in conjunction issue of this legal decision, many companies and regulators worked
with rapid microbiological methods. In 23 chapters, the book covers to determine how this decision affects microbiological test results.
how media is used in the modern pharmaceutical microbiology Date of Publication: Apr 2015. Number of Pages: 866. ISBN
setting and recaps the past, signals the future, and helps interpret Number: 1933722894. PDA Item No: Hardcover: 17328.
the present.
Pharmaceutical Contamination Control (H0736)
Date of Publication: Nov 2017. Number of Pages: 582. ISBN:
By: Dr. Halls.
9781942911159. PDA Item No: 17345. Following the success of Dr Halls' executive briefings in the field of
microbiological contamination control for pharmaceutical
Microbiology in Pharmaceutical Manufacturing, Second cleanrooms, and the publication of a collection of these briefings,
Edition, Revised and Expanded, Volume 2 (H0702) this book pursues the topics further and offers practical guidance in
contamination control.
By: By: Dr. Richard Prince Join Dr. Halls as he offers seven expert monographs on this curious,
The first edition of Microbiology in Pharmaceutical Manufacturing, complex and eclectic interest area. A glossary of terms, practical
published in 2001, is THE best selling PDA/DHI book of all time. examples throughout, and pointers to more advanced literature are
Modeled on the first edition, the 2008 completely revised and also included.
extended edition raises the bar by offering practical and current Number of Pages: 289. ISBN Number: 1-933722-02-9. PDA Item
industrial and regulatory perspectives. While in revision, 20 new No: 17246.
chapters were added and sixteen new authors contributed their
work to this book making it the most comprehensive collection of
best thinking from subject matter experts in their respective fields. Pharmaceutical Quality (Hardcover) (H0723)
Date of Publication: Feb 2008. Number of Pages: 485. ISBN By: Dr. Richard Prince
Number: 1933722207. PDA Item No: Hardcover: 17279. Pharmaceutical Quality is a collection of essays that offer an
examination of quality from the perspectives of senior experts
Microbial Control and Identification: Strategies Methods working in industry, government and academia from around the
Applications (H0720) world. Pharmaceutical Quality enriches our recognition of what
By: Dona Reber quality is, or what we think it is.
In PDA's latest release, expert microbiologists and
biopharmaceutical industry leaders explore the role of microbial I. Section One includes ten chapters that present international
and national systems (and perspectives) of quality from
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Australia, Britain, Canada, Germany, Israel, Japan and Singapore as
well as the United States.
Radiation Sterilization: Validation and Routine Operations
II. The second section of the book focuses on industrial quality Handbook (Hardcover) (H0480)
systematics, the interplay of quality systems in commercial By: Anne F. Booth
pharmaceutical manufacturing. This comprehensive handbook is intended to provide a framework
for the validation and routine operation of irradiation sterilization
III. The third and final section of the book provides processes. It defines methods to assist you in the interpretation and
perspectives on quality from industry though leaders. understanding of ancillary standards and guidelines. It offers
Date of publication: Jul 2004. Number of Pages: 758. ISBN: practical procedures for the validation and routine monitoring of
1930114613. PDA Item No: 17207 your specific radiation sterilization process. Although the scope of
the standards refers to medical devices, the requirements and
guidance may be applicable to other health care products.
Phase Appropriate GMP for Biological Processes: Pre- Date of Publication: Mar 2008. Number of Pages: 183. ISBN
clinical to Commercial Production (Hardcover) (H0622) Number: 1933722177 PDA Item No: Hardcover: 17277
Edited by Trevor Deeks
This book provides succinct and practical guidance on how to Rapid Sterility Testing (Hardcover) (H0460)
develop a biological drug product and, at the same time, stay within Edited Jeanne Moldenhauer
the regulatory expectations at each phase of the development The current compendial sterility test methodology has been fully
process! harmonized for Europe, Japan and the United States for many years.
Within this book, you can find chapters on: In spite of having a fully harmonized test methodology, in reality,
Current manufacturing and process development of Regenerative the test methodology is only effective in detecting gross
Medicine Advanced Therapy Products (RMATs), or as they are contamination in a batch of product. Manufacturers are now focused
known in the EU, Advanced Therapy Medicinal Products (ATMPs) on how their aseptically processed products might achieve a
Quality systems and GMP requirements for Phase 1 to Phase 3 shortened time to product release as part of the sterility test. To
manufacturing date regulatory support has not been gained to support a program
The impact of the Clinical Trials Directive on European GMP of parametric release for aseptically filled products. This results in
expectations and the role of the QP many companies looking at rapid sterility testing methods to reduce
The latest USP guidance on the transfer of analytical methods, the time to release for aseptically-filled products.
validation and verification of compendial procedures In this book you will find a history of the sterility test methodology
And, much more. as well as detailed discussions that provide the regulatory
Date of Publication: Feb 2018 ISBN Number: 9781942911173 requirements and allowances for gaining approval of rapid sterility
Number of Pages: 525 PDA Item No: Hardcover: 17346 test methods. Compendial requirements for validation and
implementation of these methods in the United States and Europe
Pharmaceutical Legislation of the European Union, Japan are also discussed. Subject matter experts provide information on
and the United States of America - An Overview, Updated the types of methods that can be considered for aseptic sterility
and Expanded Second Edition (Hardcover) (H0641) testing and discuss issues such as the statistical methods used to
Editor. Barbara Jentges. validate these methods, especially since many of the new
Whether you are a student, a newcomer to the pharmaceutical technologies are superior to the conventional methods. Last, there
industry or a seasoned professional, the second edition of this book are a substantial number of case studies describing how various
has something for everyone. The book presents a condensed companies have approached selecting, validating and implementing
overview of the regulatory systems and processes for marketing a new methodologies for sterility testing at their site.
drug product in the three major global regions: Japan, the United Book written in October, 2011
States and the European Union. Date of Publication: Feb 2015 ISBN Number: 1933722568
Content for each chapter has been updated and expanded by Number of Pages: 505 PDA Item No: Hardcover: 17302
authors with significant regulatory and pharmaceutical experience.
Two new chapters have been added that cover regional Recalls of Pharmaceutical Products: Eliminating
requirements for CTD-Module 1 and post-approval changes. Contamination and Adulteration Causes (Hardcover)
Subject matter is written in an easy-to-read style with added figures (H0742)
and tables which make it easy to compare differences in complex Edited. Dr. Tim Sandle
regulatory systems and key legislation. Suggested guidances are Are you prepared for recalls relating to pharmaceutical and
given throughout for further reading. Filled with useful information, healthcare medications and medical devices? This book contains
this book is a great resource for any level of expertise. details about recalls from start to finish, including advice on how to
Date of Publication: 2016. Number of Pages: 161. ISB: handle a recall and, more importantly, how they can be avoided.
9780939459858. PDA Item No: Hardcover: 13011. Read about regulatory perspectives, trends and primary causes for

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product recalls, notable recalls and lessons, quality metrics, and The author then explains training as a corrective action, evaluation
supply chain risk management. You can also find relevant of techniques, writing the report, review and approval, and
information designed to help about labels, packaging, data integrity, communication and management responsibilities. It is the perfect
methods to ensure GDP, and other industry best-practices. companion for your library shelf or computer or, perhaps, both.
Date of Publication: Mar 2020 ISBN Number: 9781942911425 "Understanding how to properly plan and perform investigations,
Number of Pages: 728 PDA Item No: 17357 how to decide on effective means to address the outcome of such
investigations, and how to use the knowledge gained from the
Risk Assessment and Management for Healthcare experience are key to process reliability and improvement. That
Manufacturing: Practical Tips and Case Studies (Hardcover) makes this book so important and the approaches presented in it so
(H0638) valuable. Enjoy the book. Learn from the journey".
Date of Publication: Jun 2020. Number of pages: 332. ISBN
Edited Tim Sandle
Number: 9781942911500. PDA Item No: Hardcover: 17359.
Avoidance of hazards and assessment of risk have long been part of
the manufacture of pharmaceuticals and healthcare products. A
SOPs Clear and Simple: For Healthcare Manufacturers
high-quality drug product must be free from contamination and
(Hardcover) (H0629)
reliably deliver the intended therapeutic dose as stated on the label
Edited Brian Matye, Jeanne Moldenhauer, Susan Schiniepp
and to achieve this manufactures must always be mindful of risk.
There are four simple sentences that define the concept of
Tim Sandle's newest book incorporates regulatory perspectives,
compliance and its relationship to Standard Operating Procedures
scientific methods and practical examples to describe approaches to
(SOPs) — Say what you do. Do what you say. Prove it. Improve it.
problem solving when assessing, managing and reviewing risk. The
Despite this concept seeming simple, the number one topic of 483
book is divided into four sections that present a formal approach to
observations for biologics, drugs, and devices from 2013 through
risk. The first section provides a look at risk assessments and
2017 included failure to follow SOPs, procedures not in writing, and
hazards, exploring the origins, looking at key concepts and
lack of adequate procedures.
philosophies and assessing the regulatory perspective. An overview
In this comprehensive guide, gain practical insight into the need for
of available tools for risk assessment and problem solving leads into
SOPs, how to write them, and what should be included in them.
specific 'soft skills' that can help to run an effective meeting, oversee
Explore the application of SOPs to the pharmaceutical,
a project and report root cause analysis and risk outcomes. The
biotechnology, and medical device industries. This useful text offers
book concludes with an extensive set of case studies to show real-
a simple, yet, straight forward approach to writing SOPs,
world applications of the tools and techniques presented. The wide
highlighting their importance in maintaining compliant operations
range of topics presented throughout the four sections includes risk
critical to manufacturing quality products.
considerations for aging pharmaceutical facilities, application of
Upon finishing this book, you'll be able to not only write out SOPs
quality risk management to cleanroom design and process incident
but also follow them to fully maintain compliance.
investigation.
Date of Publication: Jan 2019 ISBN Number: 9781942911333
Date of Publication: Sep 2016. ISBN Number: 1933722991
Number of Pages: 177 PDA Item No: Hardcover: 17348
Number of Pages: 730 PDA Item No: Hardcover: 17337
Square Root of (N) Sampling Plans: Procedures and Tables
Root Cause Investigations for CAPA: Clear and Simple. for Inspection of Quality Attributes (H0575)
(H0403) Edited: Lynn Torbeck, Joyce Torbeck
Edited James Vesper The goal of Lynn and Joyce Torbeck's book, Square Root of (N)
This text, based on workshops led by instructor and author James Sampling Plans: Procedures and Tables for Inspection of Quality
Vesper, provides practical tools for both a thorough understanding Attributes, is to show that the sqrt (N) plans are statistically correct
of risk-based CAPA investigations and regulatory acceptable and can be used in applications that minimize risk to the patient.
applications. This book presents technical and practical information for the
Beginning with topics such as why and how much investigations correct use of the three sqrt (N) attribute sampling plans.
matter, regulatory requirements, roles and responsibilities, the text While the book is oriented to the domestic and international
then progresses to the big picture. It discusses the initial discovery, pharmaceutical industry, the material is general enough to be
applying risk-based thinking to quality events and deviations, and adapted to other industries and applications.
moves on to specifics discussing: July 2013. Hardcover. 127 PÁGINAS. ISBN Number: 1933722738
• Models used in describing incidents
• Human Errors and Human Factors Software as a Service (Saas): Risk-Based Validation with
Time-Saving Templates. (H0413)
• Methods and Tools
From this book, you will learn a systematic, step-by-step approach
• Interviews for validating configurable off-the-shelf software that generates
• Immediate actions and corrections data or controls information about products and processes subject
• Corrective actions and preventive actions to regulations. You will also get access to templates the authors
• Procedures have used as training tools for more than 1,000 companies and
components of more than 300 validation projects. These tools and
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knowledge will assist you in establishing a compliant, timely, and Here is a book that one peer reviewer called "brilliant." Written by a
successful program. well-know subject matter expert, this book describes the latest
Date of Publication: Apr 2020. Bumber of Pages: 182. ISBN Number: tools, techniques and regulatory information needed to validate
9781942911494. PDA Item No: Hardcover: 17358. enterprise systems. Subjects covered include challenges, acquisition
and procurement, developing and documenting user requirements,
Square Root of (N) Sampling Plans: Procedures and Tables validation planning, governance, data migration, prototyping pilots,
for Inspection of Quality Attributes. (H0450) test strategies, electronic records, customization, risk management,
Edited: Lynn Torbeck and Joyce Torbeck SOPs, validating in the cloud and much, much more.
The goal of Lynn and Joyce Torbeck's book, Square Root of (N) Date of Publication: Feb 2015 ISBN Number: 1933722614
Sampling Plans: Procedures and Tables for Inspection of Quality Number of Pages: 471 PDA Item No: Hardcover: 17303
Attributes, is to show that the sqrt (N) plans are statistically correct
and can be used in applications that minimize risk to the patients. Why Life Science Manufacturers Do What They Do in
This book presents technical and practical information for the Development, Formulation, Production and Quality: A
correct use of the three sqrt (N) attribute sampling plans. History (Hardcover) (H432)
While the book is oriented to the domestic and international by: Lynn Torbeck
pharmaceutical industry, the material is general enough to be In a passionate retrospective of a successful career built on thinking
adapted to other industries and applications. statistically and applying that approach to quality in pharmaceutical
Date of Publication: Jan 2015. Number of Pages: 130. ISBN manufacturing, Lynn Torbeck has created a "must-read" for anyone
Number: 1933722738. PDA Item No: Hardcover: 17314. involved in product development, formulation, manufacturing and
quality. Because this book is not organized in a linear fashion,
Torbeck encourages readers to dip into any chapter that is of
Steam Sterilization: A Practitioner’s Guide (Hardcover)
interest. This book is not a statistics text per se; however, it shares
(H0672)
the author's passion and decades of experience for statistics applied
By: Jeanne Moldenhauer
to pharmaceutical quality by showing how they can be used in real-
This book contains pragmatic details on how to accomplish the world pharmaceutical quality problems.
tasks necessary for a sterility assurance program for steam
Date of Publication: 2015. Number of Pages: 455. ISBN
sterilization processes. Each chapter author is a subject matter
Number: 1933722924. PDA Item No: Hardcover: 17333.
expert and has a minimum of 10 years of hands-on experience in
the topics discussed.
Date of Publication: Dec 2002. Number of Pages: 740. ISBN
PARA MAYORES INFORMES Y COTIZACIONES FAVOR
Number: 1930114389. PDA Item No: Hardcover: 17183. DE CONTACTAR:

www.grupoterrafarma.com
Torbeck`s Statistical Cookbook for Scientists and Engineers E-mail: info@grupoterrafarma.com
(Hardcover) (H0648) o telefónicamente a:
Edited: Lynn Torbeck
In the Statistical Cookbook for Scientists and Engineers, you will find MÉXICO: (+5255) 56509274 / 56487482
tried and true, practical statistical "recipes" that provide a book of
specific and unique statistical modules useful for evaluation of Whatsapp: (+52-55) 45480411 / 29064357
industrial studies. These modules are designed for the busy
industrial worker, who needs to apply statistical techniques with the
assurance he or she is using the technique correctly. Horario: 09:00-18:00 LUNES A VIERNES HORA DE LA
These modules were developed based upon years of experience in CIUDAD DE MÉXICO
the field and training at many facilities, including the U.S. FDA, and
are intended to fill a niche that is not currently addressed by other Para mayor agilidad en el registro de sus datos y
statistical books. Each module uses the same format with preparación de la cotización, mencione el número de
modifications. Where helpful, a worked example is presented in a ejemplares que quiere y el código “H” que aparece entre
parallel format to the procedure. paréntesis.
Scientists and engineers engaged in healthcare as well as other
industrial manufacturing will find this text an invaluable resource.
Date of Publication: Oct 2017 ISBN Number: 9781942911142
Number of Pages: 241 PDA Item No: Hardcover: 17344.

Validating Enterprise Systems: A Practical Guide (H0578)

Author: David Stokes

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