Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing

414 Pages·2.42 MB·english

by  Mollah H.

RISK MANAGEMENT
APPLICATIONS IN
PHARMACEUTICAL AND
BIOPHARMACEUTICAL
MANUFACTURING

RISK MANAGEMENT
APPLICATIONS IN
PHARMACEUTICAL AND
BIOPHARMACEUTICAL
MANUFACTURING
Edited by
A. HAMID MOLLAH
MIKE LONG
HAROLD S. BASEMAN
A JOHN WILEY & SONS, INC., PUBLICATION
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ISBN:9780470552346
10987654321
CONTENTS
Preface vii
Contributors xi
About the Authors xiii
1 Background and Introduction 1
HaroldS.BasemanandA.HamidMollah
2 Risk Management Tools 17
MarkWalkerandThomasBusmann
3 Risk Management: Regulatory Expectation, Risk Perception,
and Organizational Integration 49
MikeLong
4 Statistical Topics and Analysis in Risk Assessment 75
MikeLong
5 Quality by Design 89
BruceS.Davis
6 Process Development and Clinical Product Manufacturing 101
KarenS.Ginsbury
v
vi CONTENTS
7 Points to Consider for Commissioning and Qualification
of Manufacturing Facilities and Equipment 129
HaroldS.BasemanandMichaelBogan
8 Process Lifecycle Validation 179
A.HamidMollahandScottBozzone
9 Aseptic Processing: One 227
JamesP.AgallocoandJamesE.Akers
10 Aseptic Processing: Two 243
EdwardC.Tidswell
11 Pharmaceutical Product Manufacturing 275
MarleneRaschiatore
12 Biopharmaceutical Manufacturing 325
RuhiAhmedandThomasGenova
13 Risk-Based Change Control 367
WilliamHarclerode,BobMoser,JorgeA.Ferreira,
andChristopheNoualhac
Index 387
PREFACE
With the introduction of FDA’s 21st century GMP and ICH initiatives (such
as Q8 Pharmaceutical Development, Q9 Quality Risk Management, and Q10
Pharmaceutical Quality System), drug manufacturing entered a new era of risk
management. Although regulatory agencies are encouraging the use of risk man-
agement in pharmaceutical and biopharmaceutical product manufacturing, regu-
latory guidance and comprehensive literature on how to use and implement risk
management is limited and in need of further development. This book will fill
this large void and assist both industry as well as agency to implement a com-
pliant and effective risk management approach. The book has been prepared to
provide the readers with some points to consider for managing risks to product
qualityincurredduringthemanufactureofbiopharmaceuticalandpharmaceutical
products, including
• Industry trend towards to use of QRM for manufacturing control
• Regulatory expectations
• Use of limited resources and cost control
• Maintaining and assuring product quality
• Process and quality improvement
Over the years, the authors and editors of this book have presented to and
met with numerous people at many companies, plants, and organizations in the
pharmaceutical industry, asking about and providing instruction in quality risk
management. While audiences have generally become more aware of the topic,
including the expectation and perhaps even the benefit of its use, it has not been
clear whether the aspects of its implementation have been fully appreciated and
vii
viii PREFACE
takenadvantageof.Wesawmanyinstanceswhereresourcesandtimewerespent
to complete hundreds of risk assessments, but never utilized into manufacturing
operations. Identification of risk without action has minimal benefit and can be
viewed as shifting a company from ignorance to avoidance. This has led the
editors of this book to believe that there was a strong need for further expla-
nation and education on approaches for the practical implementation of quality
risk management for pharmaceutical and biopharmaceutical processes. Over the
past half-decade or more, companies and individuals have explored, developed,
implemented, benefited, and refined methods for risk management, assessment,
review,anddecisionmakingthatutilizeapproaches,models,systems,techniques,
schemes and plans—some more effective, some less. This book creates this link
by exploring risk management of manufacturing processes through a collection
of chapters written by some of the leading experts in pharmaceutical and bio-
pharmaceutical product manufacturing. The editors chose topics that represented
the most significant challenges in the industry at the time of writing.
The ultimate goal of the risk management process is to bring focus and effort
to the issues in an organization that imparts the highest risk to product quality
and/or patient safety. The degree of formality and rigor applied should be com-
mensurate with the complexity and/or criticality of the element or issue. There
are many tools that can be applied, which are new to many in the industry. For
risk assessors, there can be confusion with the level and detail of an assessment
as well as the potential subjectivity, which can permeate an assessment. These
issues are compounded with the uncertainty of the regulatory framework and
application of risk. Hence, it is quite important to use proven and compliant risk
management approaches to assure acceptable results.
Thisbookwaswrittenbyauthorswhohaveusedriskmanagementtoimprove
processes,investigatefailures,designoperations,validateprocesses,andincrease
overall quality and productivity of their respective operations. This book is not a
collectionofhistoryorfundamentals,norisitabookoftheoreticaldesiredstates.
Although the book does explore and present some background and introduction,
it is primarily focused on the practical presentation of points to consider and
methodstohelpthereadermakebetterdecisionsbasedonriskandtohelpmanage
that risk. This book is written by people who lived through the introduction of
thistopictoourindustryandparticipatedinitsimplementation.Ourauthorswant
to communicate best practices to help the reader better implement and benefit
from its use without experiencing the unnecessary burden and redundancies that
often accompany activities in this industry. This book provides examples of risk
management in areas from the process development to sterile fill operations.
Riskmanagementshouldbeamethodformakingourjobsmoredoable,adding
toourunderstandingofprocesses,andhelpingusmakebetterdecisions.Itshould
not be just a checklist item, another corporate directive, of little value. To the
contrary, the objective of this book is to help the reader understand, appreciate,
use, and benefit from risk management. We hope you will find it useful and
enjoyable.
PREFACE ix
Weexpressourgratitudetoalltheauthorsforcontributingtothisbook.Thanks
to Anurag Rathore for his encouragement and persuasion to complete this book.
We also thank Lynn Torbeck at Torbeck and Association, Kevin O’Donnel at
the IMB (Irish Medicines Board), Emma Ramnarine and David Reifsnyder at
Genentech, Penny Butterell and Simon Smith at Pfizer, and Brian Turley and
Walter Henkels at Valsource for providing feedback.
Thank you,
The Editors
CONTRIBUTORS
James P. Agalloco, Agalloco & Associates, Belle Mead, NJ
Ruhi Ahmed, Regulatory Affairs, Ultragenyx, Novato, CA
James E. Akers, Akers Kennedy & Associates, Kansas City, MO
Harold S. Baseman, ValSource LLC, Jupiter, FL
Michael Bogan, Integrated Commissioning & Qualification, LLC, Hope
Valley, RI
Scott Bozzone, Pfizer Inc., Peapack, NJ
Thomas Busmann, Focus Compliance & Validation Services, Knoxville, TN
Bruce S. Davis, Bruce Davis (Global Consulting), Haslemere, Surrey, UK
Jorge A. Ferreira, Jacobs Engineering Group, Conshohocken, PA
Thomas Genova, Johnson & Johnson, Raritan, NJ
KarenS.Ginsbury,PCIPharmaceuticalConsultingIsrael,PetachTikvah,Israel
A. Hamid Mollah, Quality Engineering and Validation, XOMA Corporation,
Berkeley, CA
William Harclerode, Forest Labs, Harborside Financial Center, Jersey City, NJ
Mike Long, ConcordiaValSource, Wayland, MA
Bob Moser, Jacobs Engineering, Conshohocken, PA
xi