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Universal Study Design for Instrument Changes in Pharmaceutical Release Analytics.

Anne B Ries1, Maximilian N Merkel1, Kristina Coßmann1

  • 1Quality Control, Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach an der Riss, Germany.

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Summary
This summary is machine-generated.

Pharmaceutical quality control requires consistent analytical methods. A new instrument comparability study ensures seamless transitions between instruments, preventing costly re-validations and maintaining data integrity for release analytics.

Keywords:
comparability | instrument update | instrument replacement | ICE3 to Maurice | quality control | state-of-the-art

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Area of Science:

  • Pharmaceutical Science
  • Analytical Chemistry
  • Biotechnology

Background:

  • Maintaining consistent analytical method performance over decades is crucial for pharmaceutical quality control (QC).
  • Instrument hardware/software updates or vendor changes challenge long-term analytical method reliability in pharmaceutical QC.
  • Ensuring comparability between analytical instruments is essential for uninterrupted product release analytics.

Purpose of the Study:

  • To design and implement an efficient instrument comparability study for pharmaceutical QC.
  • To assess potential performance differences between analytical instruments.
  • To provide a data-driven basis for risk assessment and decision-making regarding instrument transitions or updates.

Main Methods:

  • A universally applicable study design involving two experiments on the new instrument.
  • Generation of a statistically meaningful dataset for comparison with historical or validation data.
  • Implementation in a Good Manufacturing Practice (GMP) environment using imaged capillary isoelectric focusing (icIEF) instruments (ICE3 vs. Maurice C).

Main Results:

  • The study confirmed equal or superior performance of the Maurice C instrument compared to the ICE3.
  • All tested parameters demonstrated comparable or improved results on the Maurice C.
  • The generated data supports the continuation of release icIEF measurements on the Maurice C.

Conclusions:

  • The developed instrument comparability study design is efficient and broadly applicable to release analytical methods.
  • The study provides a science-based approach to manage instrument changes, potentially avoiding full re-validation.
  • Seamless continuation of critical release analytics is achievable with data-backed instrument comparability assessments.