Compliance with quality regulations
that protect patients' safety is a critical
requirement for the pharmaceutical
industry. Regulatory compliance
goes a long way toward proving that a
given product's target for quality has
been achieved and documented. Pharmaceutical
Manufacturing Handbook:
Regulations and Quality is intended to
help readers understand how to comply
with regulations and how to adapt
a quality unit's routine activities to facilitate
compliance.
In the book's preface, editor Shayne
Cox Gad says the book describes "all
regulatory aspects and requirements
that govern how drugs are produced
for evaluation (and, later, sale to and
use) in humans." The book's back cover
says it contains "everything you need
to ensure full compliance and superior
quality control."
The book's eight sections cover topics
such as good manufacturing practices
(GMPs) and other US Food and
Drug Administration guidelines, international
GMP regulations, quality,
process analytical technology (PAT),
personnel, contamination and contamination
control, drug stability, and
validation.
The book benefits from the work of
more than 40 authors—respected academics
and industry veterans—who
contributed their years of expertise in
various topics.
Pharmaceutical
Manufacturing
Handbook:
Regulations and
Quality, Shayne
Cox Gad, Ed., Wiley,
London, 2008, 856
pp., ISBN: 978-0-
470-25959-7
|
The book's first two sections are
devoted to US and international regulation
of GMPs. The first section describes
FDA's GMP regulation and
provides a good reference to other pertinent
regulations and guidelines such
as scale-up, postapproval changes, and
PAT publications. These sections provide
useful advice for complying with
regulations.
A chapter titled "Enforcement of
Current Good Manufacturing Practices"
includes a surprising and illuminating
discussion about FDA's collaboration
with the Federal Bureau of
Investigations during certain inspections.
The next section discusses various
aspects of quality. Despite offering detailed
discussions, chapters about total
quality management, the role of quality
systems and audits, creating and overseeing
quality-management systems,
and quality-process improvements are
quite easy to read. These chapters also
provide materials that can be used in a
quality operation (e.g., a checklist for
performing a quality audit).
The section dedicated to PAT offers
a discussion about chemical imaging
and chemometrics. Passages provide
details about the background of PAT,
its benefits, and the various methods
of implementing PAT.
The comprehensive section about
drug stability provides readers a scientific
understanding of how to determine
a product's shelf life. This section
discusses alternative accelerated testing
methods through variable-parameter
kinetics studies.
The section about validation includes
considerations of essential matters such
as analytical methods, laboratory instruments,
and pharmaceutical manufacturing.
This portion omits other
important types of validation, however,
such as computer validation, process
validation, and facility validation.
Nevertheless, this book is a valuable
reference for anyone interested in drug
stability, quality, and PAT. The contributors'
expertise ensures that the book
shines in its treatment of those topics.
It is not far off the mark to say that the
book contains "everything you need to
ensure full compliance and superior
quality control."
Rory Budihandojo is a computer validation manager at Boehinger-Ingelheim, 2820 N. Normandy Dr., Petersburg, VA 23805, tel. 804.504.8373, fax
804.504.8637, rbudihandojo@bichemicals.com
He is also a member of Pharmaceutical Technology's Editorial Advisory Board.
