A Quality-Control Guide Fails to Train the Trainer

August 2, 2011
Pharmaceutical Technology
Volume 35, Issue 8

A book about developing quality-control training manuals provides a wealth of information and a dearth of practical help.

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.

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.

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 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.

The book is divided into sections. The first section, labeled "Analytical Method, Techniques, and Quality Measures for General Pharmaceutical Products," includes 13 SOPs. The second section, "Analytical Methods, Techniques, and Quality Measures for Biological Products," includes four SOPs. The third section, "Laboratory Training Manual," includes seven SOPs. The fourth section, "Assessment of Training," includes two SOPs. The fifth section, "Training Assessment with Quiz and Answers," includes 26 SOPs and several quizzes followed by answers. The sixth section, "Training Log," includes five SOPs. Additional sections, such as "Analytical Methods Validation Master Plan," "Analytical Methods Validation Protocol," "SOP for Annual Re-Qualification of HPLC Units," "SOP for Annual Re-Qualification of GC Units," "Good Lab Practices," and, "Regulations."

Another shortcoming of the book is its series of training-assessment SOPs. The book's SOPs will only give a low-level assessment, and a trainee that could pass these assessments will not be equipped to conduct the analytical procedures. The strength of the book is that it attempts to comply with several guidelines and generally succeeds. The book does not acknowledge, however, the various training requirements in different areas of the world.

The section titled "Training of Chromatographic Techniques" has a flaw that is emblematic of the whole book. The procedure for assessing a training program is not included in this SOP as it should be, but later in a "Training Assessment" section. This organization unnecessarily separates training from its assessment and breaks the book's continuity. This poor organization is repeated for other methodologies throughout the book.

Even elements of the book's design and layout are misleading at best and obtrusive at worst. Quality Control Training Manual deals mainly with pharmaceuticals and occasionally examines QC methods for the analysis of biotechnology derived products. In this light, the picture of DNA strands on the cover is misleading because it implies a focus on large-molecule products. Also, a design feature that is repeated at the top of each page of the book is rather annoying. It is supposed to represent what an SOP looks like, and it includes the name of the organization, the ID number, the name of the issuing officer, the department, and the date of issue. Perhaps this information might be useful on the first page of an SOP, but it is not necessary on every page, and it is certainly an unwelcome distraction here.

Quality Control Training Manual falls short of its goal of providing helpful resources that allow personnel to develop QC training manuals. The book is written at an elementary level that would have little benefit for anyone other than individuals starting their careers in a QC laboratory. Seasoned QC personnel who need help developing protocols for their firms should look elsewhere for guidance.

Roger Dabbah is a principal consultant at Tri-Intersect Solutions and an associate professor of technology and engineering management at the University of Maryland, University College, Graduate School, College Park, MD 20742, tel. 301.762.9258, fax 301.762.5356, rdabbah@verizon.net. He is also a member of Pharmaceutical Technology's Editorial Advisory Board.