• Home /
  • Articles /
  • The Good Cascade Impactor Practice (GCIP) Concept: A systematic approach to risk management of erroneous measurements in the assessment of inhaler emitted aerosol aerodynamic particle size distributions (APSDs)
← Back to search results

The Good Cascade Impactor Practice (GCIP) Concept: A systematic approach to risk management of erroneous measurements in the assessment of inhaler emitted aerosol aerodynamic particle size distributions (APSDs)

  • Publication Date: 04/01/2014
  • Author(s):
    Mitchell, Jolyon P.
  • Organization(s):
    Jolyon Mitchell Inhaler Consulting Services, Inc.
  • Article Type: Technical Articles
  • Subjects: Device Design, Industry Issues and Trends, Instruments, Particle Characterization, Product Development/Formulation, Testing, Validation, and Regulatory Compliance
In the OIP quality control environment, the risk of out-of-specification (OOS) measurements can be minimized by using the GCIP concept to identify and control errors.

In the OIP quality control environment, the complexity of the method can be a contributory cause of measurements that are deemed to be out-of-specification (OOS). The Good Cascade Impactor Practice (GCIP) concept is a means whereby the risk of such an occurrence can be minimized by following a logical process through which errors caused by the operator (MAN), the apparatus itself (MACHINE), the assay method (ANALYSIS or MEASUREMENT) and finally the formulation/delivery device (MATERIAL) are identified and controlled.

Download PDF