A Quality-Control Guide Fails to Train the Trainer - Pharmaceutical Technology

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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.


Pharmaceutical Technology
Volume 35, Issue 8

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,
. He is also a member of Pharmaceutical Technology's Editorial Advisory Board.


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