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.
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, [email protected]