The book's first chapters provide practical do's and don'ts to help regulatory-affairs professionals prepare for FDA inspections. The section offers tips about escorting and interacting with inspectors. For example, the book suggests restricting the number of participants in an inspection to optimize efficiency. It also warns against endless philosophical discussions once the company's point of view has been clearly communicated to the inspector.
The final section of the book looks at quality control-related FDA requirements. A chapter about validating analytical methods compares FDA and ICH guidance documents. It also explores the relative importance of accuracy, precision, repeatability, specificity, detection limit, and linearity difference for identity, impurity, assay, and dissolution tests. The chapter contains an excellent review of how FDA regulations affect the validation of analytical methods.
A subsequent chapter provides guidance for selecting a valid sampling plan that conforms with 21 CFR 211 regulations. The chapter discusses several sampling methods and tools for various types of containers and materials. It concludes with a discussion of statistical sampling.
The book ends on the topic of handling out-of-specification (OOS) results, including a detailed flow chart that shows how to conduct an investigation when an OOS result is obtained in the laboratory. It also discusses how an OOS investigation should complement a corrective and preventive action program and an overall quality system.
FDA Requirements for CGMP Compliance would be useful to anyone in the pharmaceutical industry who is responsible for regulatory inspections. The book would be particularly valuable to employees who must understand US and European regulations and inspection practices. The book's greatest assets are its excellent references and regulatory document source information.
Russell E. Madsen is a member of Pharmaceutical Technology's editorial advisory board and president of The Williamsburg Group, 18907 Lindenhouse Rd., Gaithersburg, MD 20879, tel. 301.938.4266, fax 301.869.5016, [email protected]