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.
