TEVA

Background

Transport simulation followed typical distribution mode for the pharmaceutical industry. A transport simulation test plan was applied to the general distribution model outlined in Parental Drug Association (PDA) technical report 53 (TR53) and represents the time product is in transit, not the actual dock to dock time. Much of the transit time is spent waiting for the next move.

Objectives

  • Confirm commercial drug product formulation using transport simulation.
  • Test for visual defects in primary container and stability of drug product.
  • Test executed according to protocol and all equipment is calibrated.

Results

  • Transport simulation was effective in testing drug product packaging and stability in a distribution environment.
  • Defined, tested and confirmed no impact from the physical hazards encountered during transport.
  • Demonstrated to regulatory agencies that simulation testing and robust study design is acceptable.

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