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Review Article - Asian Journal of Biomedical and Pharmaceutical Sciences (2020) Volume 10, Issue 70
Review on comprehensive understanding of building an analytical quality by design for drug manufacturing process.
When knowledge based on pure scientific understanding and quality risk management is applied to
product and process learning with regulation on process control along with a systematic approach for
development of predefined objectives in analytical field then it is called as quality by design or QBD it
follow ICH guidelines for quality in pharmaceutical product concept of QBD also extends to analytical
methods, it is mandatory process in QBD to define a goal.
A protocol for the method which will continue monitoring the process throughout in a systematic way
and working on alternate methods as well to get optimal performance, the methods given are carefully
analyzed in structured pattern for risks and is put for a challenge of the validity of method which later
on can be taken for the criteria, benefit of these studies.
The performances can be improved as well as clearly understood along with the risk management and
desired performance methods which can also be validated later on, the review briefly gives an inside
view of application of analytical QBD in industries and its current status with examples and principles
of analytical methods in HPTLC ,titration for moisture content, determination of toxic impurities in
mixtures, quantative colour measurement and various spectroscopic method for identification of
chemical moiety.
QBD developed spectroscopic and chromatographic method is usually done as per ICH Q8 R2, the
critical parameters are compared to principle observation and analysis, the HPTLC method employs
solvent usage and detection of absorbance and wavelength comparison.