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U.S. Department of Health and Human Services

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Volume IV - 3.1 Introduction

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Orientation and Training

Food and Drug Administration

DOCUMENT NO.:

IV-03
VERSION NO.: 1.7

Section 3 - Drug Analysis

EFFECTIVE DATE: 10-01-03REVISED: 02-14-13

The drug analysis training program provides preliminary training in basic technical areas. The ORA U New Hire Laboratory Analyst Training curriculum (Bingo card) specifies sections of the ORA Lab Manual as part of the New Hire Curriculum.  Described are drug analyses for new hire training and suggested on-the-job training samples of selected techniques.  Additional techniques and training exercises are included that are occasionally used in drug analysis.

The Center for Drugs and Evaluation Research (CDER) is responsible for establishing the inspectional and analytical guidelines associated with the FDA drug analysis programs. Drug Compliance Programs are found in the Compliance Program Guidance Manual (CPG).

This training chapter introduces the trainee to regulatory pharmaceutical analyses in FDA, analytical separation techniques, instrumentation, and the resolution to typical problems a trainee will encounter with pharmaceutical analyses.  The trainee should discuss each exercise in advance with the trainer.  If a laboratory does not perform analyses in that area, that portion of the training can be abbreviated or eliminated.

The training is separated into modules using defined pharmaceuticals. Before beginning the sample analysis, the trainer should consider and discuss topics that will cultivate a thoughtful and responsible approach to each assignment. Topics may include the following:    

  • Why was the sample collected? (assume it was not a training sample).
  • Criteria for method selection.  What care is taken in selecting an analytical method? Is the method the correct one? Is the method valid?
  • Correct sample handling. Is there a microbiological analysis associated with this sample that may necessitate the microbiologists to handle the sample first?
  • Is there enough sample for all the regulatory tests? For an additional and check analysis? For an exhibit, if needed?
  • What regulatory action might result from the analysis of the sample? 

When the trainee has completed each exercise, the analysis, worksheet preparation, and answers to the questions should be discussed thoroughly. The analyst also shows that they are proficient in the technique and instrumentation.