Abstract

QUALITY BY DESIGN BASED APPROACH FOR ANALYTICAL METHOD VALIDATION

Bornare Snehal Laxman*, Shingote Vishakha Shankar and Suhas Siddheshwar

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Abstract

In the case of pharmaceutical processes, quality by design (QbD) is used to ensure a predetermined product quality. The International Conference on Harmonization (ICH) points Q8 (R1) (pharmaceutical development), Q9 (Quality risk management [QRM]), and Q10 (Quality risk management [QRM]) clarify the QbD concept unit of measurement (pharmaceutical quality system). According to the ICH Q8 (R1) guideline, "a systematic approach to development that begins with predefined objectives and stresses product and methodology understanding and methodology management, supported by strong science and QRM." The consequences of various input variables (e.g., methodological parameters and materials) of the merchandise development methodology on the end product were investigated using the QbD approach (active pharmaceutical ingredient or drug product). The late QbD method combines QRM principles with methodology and analytical technology (PAT). QbD paired with methodology analytical technology (PAT) tools improves methodology management and ensures that the unit of measurement for item quality attributes is regularly reached.

Keywords: Quality by Design, CQA, QTPP, Risk assessment, Design of Experiment, PAT analysis.