Required Reading for Regulatory-Affairs Personnel - Pharmaceutical Technology

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Required Reading for Regulatory-Affairs Personnel
How do you answer an inspector's questions? How do you validate analytical methods? One book has answers for compliance professionals.


Pharmaceutical Technology


Russell E. Madsen
FDA Requirements for CGMP Compliance is intended to provide practical information and examples to help pharmaceutical professionals comply with current good manufacturing practice (CGMP) requirements. The book is written from a European perspective and compares the US Food and Drug Administration's regulations and inspection practices with their European equivalents.

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.


FDA Requirements for CGMP Compliance, Author: Concept Heidelberg, Publisher: Editio Cantor Verlag, Aulendorf, Germany, 2007, 144 pp., ISBN 978-3-87193-363-9.
The chapter titled "Complaints and Notifications of Deficiency by the FDA" contains excellent information about FDA's investigational procedures. It briefly describes the agency's "Regulatory Procedures Manual" and "Investigations Operations Manual" and includes website links to these and other documents.

Risk analysis has recently been a topic of interest to the pharmaceutical industry, largely as a result of FDA's CGMPs for the 21st Century initiative and International Conference on Harmonization's (ICH) Q9: Quality Risk Management. The second section of FDA Requirements examines hazard analysis and critical control points (HACCP). This technique helps identify and control, or eliminate, processing steps that can jeopardize product quality. A particular highlight of that chapter is a practical example of applying HACCP analysis to an aseptic-filling operation for sterile-powder finished product. The section also describes FDA's risk-based approach to validation.




The chapter about risk analysis and mitigation focuses on computer systems used in the pharmaceutical industry. It shows how the risk analysis and validation of those systems should comply with the CGMPs for the 21st Century initiative and ICH Q9. Useful flow charts demonstrate process and subprocess validation. The chapter also includes a handy illustration of subprocess failure mode and effect analysis.

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,

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