Stability Management

Stability Management

“The purpose of stability testing is to provide evidence on how the quality of an active pharmaceutical ingredient or medicinal product varies with time under the influence of a variety of environmental factors such as temperature, humidity, and light, and to establish a re-test period for the active pharmaceutical ingredient or a shelf life for the medicinal product and recommended storage conditions”

(ICH, WHO, USFDA, EMEA)

QuaLIS Stability Management

Stability Management helps an industry record stability studies.

  • Batches for stability studies go through a registration process
  • QuaLIS stability protocol manager records conditions
  • The system tracks chambers availability, storage locations, etc.
  • Batches then are taken for stability studies using protocols & chambers
  • Study creation involves time points for samples & tests to be conducted
  • Samples scheduled to continue their life cycle through LIMS & close
  • Reports like crosstab time point-wise can be generated
  • Data can be exported for further analyses
  • Special reports like shelf-life & statistical can be integrated with the solution

Key Benefits

  • The manual system is becoming questionable
  • Difficult to manage with increased batch size
  • Improved productivity in the electronic system
  • Better traceability of samples stored, pulled, tested
  • Quicker reports for decision making

Deployment Options

  • Any pharmaceutical quality control stability study
  • R&D conducting accelerated stability studies
  • Industries that need stability studies like food & beverage

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