Sampling Considerations

  • Dawen Kou
  • Hua Ma
  • Edmund J. Bishop
  • Shangdong Zhan
  • Hitesh P. Chokshi


Accurate analytical data for pharmaceutical dosage forms are dependent on adequate sample preparation and appropriate sample analysis methods. In addition, in order for the results to truly reflect the quality of the overall batch, the sample tested must be representative of the batch. Sampling is the first step and a critical aspect of the overall analysis process. Many analysts, however, are not as familiar with sampling techniques and principles as they are with analytical techniques or even sample preparation techniques. This chapter covers some fundamental sampling considerations and strategies relevant to pharmaceutical dosage forms. Both the theoretical aspects and applications in the development, manufacture, and quality control of pharmaceutical products are discussed. Examples of issues caused by sampling bias/errors are also given.


Sampling Plan Acceptance Criterion Dosage Unit Pharmaceutical Dosage Form Process Analytical Technology 
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Copyright information

© Springer Science+Business Media, LLC 2011

Authors and Affiliations

  • Dawen Kou
    • 1
  • Hua Ma
    • 2
  • Edmund J. Bishop
    • 3
  • Shangdong Zhan
    • 2
  • Hitesh P. Chokshi
    • 2
  1. 1.Pharmaceutical and Analytical R&DHoffmann La-Roche Inc.NutleyUSA
  2. 2.Pharmaceutical and Analytical R&DHoffmann-La Roche Inc.NutleyUSA
  3. 3.Quality Laboratory OperationsCelgene CorporationSummitUSA

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