A Quality-Control Guide Fails to Train the Trainer

A book about developing quality-control training manuals provides a wealth of information and a dearth of practical help.
Aug 02, 2011
Volume 35, Issue 8

Quality Control Training Manual is not a traditional quality-control (QC) training manual, nor does it pretend to be one. Rather, the book describes the factors involved in QC that a trainer would have to consider when developing a training manual. The authors, Syed Imtiaz Haider and Erfan Asif Syed, should be congratulated for writing a comprehensive book. Their approach, however, makes the book difficult to read and makes its recommendations even more difficult to implement.

Quality Control Training Manual: Comprehensive Training Guide for API, Finished Pharmaceutical and Biotechnologies Laboratories, by Syed Imtiaz Haider and Erfan Asif Syed, CRC Press, Boca Raton, FL, 2011, 456 pp., ISBN: 9781439849941
The authors valiantly attempted to include every possible shred of information that they believed would be useful for individuals responsible for developing QC training manuals. But perhaps the book is too comprehensive to make it useful and practical. For example, the section about microbiological methods and analysis for water monitoring lists numerous requirements in the standard operating procedure (SOP). Yet a student will not get the specifics he or she needs to be trained in the methods.

The book's thoroughness is matched by its lack of specificity. Given that each pharmaceutical company's quality-assurance department should develop the details of each quality-related SOP, the information that the authors provide is too general and will confuse the person developing a training manual.

The few details that are included are counterproductive and have scant immediate utility. For example, the authors provide a lot of detail about the theories behind the various chromatographic techniques. But to train a technician, one has to provide at least the sequence of events in the procedures, the list of reagents needed, and the various possible errors that could be made. None of this information is provided.

The authors acknowledge that a given trainer will have to tailor his or her QC training manuals to the idiosyncrasies of his or her specific pharmaceutical organization, its product lines, its philosophy of quality assurance, and the regulatory requirements of a particular environment. SOPs are specific for methods as well as for products. Products come in various dosage forms, and each should be treated distinctly. Each organization uses instrumentation specific for its product lines, thus a general SOP training will not be useful. However, the text largely ignores this reality and offers little guidance about how a trainer could customize his or her manuals.

The content of the book is reminiscent of the content of a pharmacopeia, especially in its organization into monographs and general chapters. The book, however, does not differentiate between these sections, rendering the classification essentially meaningless. Most manufacturers consult the major pharmacopeias and translate their requirements and analytical methodologies into SOPs. The authors apparently intended their readers to use this book the same way. This strategy would not be feasible for readers, however, because the pharmacopeias are much more detailed and specific than this text is.

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