A Path to Quality and Compliance

July 2, 2008
Rory Budihandojo
Pharmaceutical Technology
Volume 32, Issue 7

A new book explains process analytical technology, drug stability, and quality.

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 adapta quality unit's routine activities to facilitate compliance.

In the book's preface, editor ShayneCox Gad says the book describes "allregulatory aspects and requirementsthat govern how drugs are producedfor evaluation (and, later, sale to anduse) in humans." The book's back coversays it contains "everything you needto ensure full compliance and superiorquality control."

The book's eight sections cover topicssuch as good manufacturing practices(GMPs) and other US Food andDrug Administration guidelines, internationalGMP regulations, quality,process analytical technology (PAT),personnel, contamination and contaminationcontrol, drug stability, andvalidation.

The book benefits from the work ofmore than 40 authors-respected academicsand industry veterans-whocontributed their years of expertise invarious topics.

The book's first two sections aredevoted to US and international regulationof GMPs. The first section describesFDA's GMP regulation andprovides a good reference to other pertinentregulations and guidelines suchas scale-up, postapproval changes, andPAT publications. These sections provideuseful advice for complying withregulations.

PharmaceuticalManufacturingHandbook:Regulations andQuality, ShayneCox Gad, Ed., Wiley,London, 2008, 856pp., ISBN: 978-0-470-25959-7

A chapter titled "Enforcement ofCurrent Good Manufacturing Practices"includes a surprising and illuminatingdiscussion about FDA's collaborationwith the Federal Bureau ofInvestigations during certain inspections.

The next section discusses variousaspects of quality. Despite offering detaileddiscussions, chapters about totalquality management, the role of qualitysystems and audits, creating and overseeingquality-management systems,and quality-process improvements arequite easy to read. These chapters alsoprovide materials that can be used in aquality operation (e.g., a checklist forperforming a quality audit).

The section dedicated to PAT offersa discussion about chemical imagingand chemometrics. Passages providedetails about the background of PAT,its benefits, and the various methodsof implementing PAT.

The comprehensive section aboutdrug stability provides readers a scientificunderstanding of how to determinea product's shelf life. This sectiondiscusses alternative accelerated testingmethods through variable-parameterkinetics studies.

The section about validation includesconsiderations of essential matters suchas analytical methods, laboratory instruments,and pharmaceutical manufacturing.This portion omits otherimportant types of validation, however,such as computer validation, processvalidation, and facility validation.

Nevertheless, this book is a valuablereference for anyone interested in drugstability, quality, and PAT. The contributors'expertise ensures that the bookshines in its treatment of those topics.It is not far off the mark to say that thebook contains "everything you need toensure full compliance and superiorquality 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.