BUSINESS
INFORMATICS FOR QBD
I
ncreased expectations of health authorities and other regulatory bodies, to incorporate Quality-by- Design (QbD) are having a dramatic impact on product development groups and their supporting corporate informatics infrastructure. One impact is the requirement
for control justification strategies and rationales to achieve the Quality Target Product Profile (QTPP); and the necessary assessment of critical quality attributes for substances and formulated products intended for human consumption and medicinal use. Specifically, for each unit operation in any manufacturing process – whether it be synthetic steps in a chemical process; addition of ingredients; stirring or agitation, and heating or chilling, say in a food or beverage production line; or formulation steps during consumer product production – developers are expected to perform a concerted risk assessment.
This assessment requires the
careful consideration of the critical material attributes of all input materials to ensure their physical or (bio)chemical properties or characteristics are within appropriate limits, ranges or distributions, and the critical process parameters of unit operations.1
Andrew Anderson, looks at some of the challenges that can be addressed with informatics solutions
With this in mind, developers are
challenged to process, assemble and review appropriate material and process information in order to perform this important risk assessment effectively. One of the biggest challenges is that the relevant types of information, data and knowledge required exist in disparate systems and formats. The first is chemical or biological
substance information, which includes chemical structures or sequence information. Another format is known as process information, comprising of unit operation conditions, materials used, location, equipment information, operator identification, suitable references to operating procedures and training and calibration records. There is also unit-operation specific molecular composition characterisation data: spectral and chromatographic data collected to identify and characterise compounds and mixtures (LC/MS, NMR, UV, IR).
Additionally, there are the
following three formats – composition differences in materials between specific unit operations and across all unit operations; comparative information for each batch for a single ‘process’, which is a single set of unit operations that are employed to produce a product or substance; and comparative information for any or all employed processes. Cross-functional development
project teams, comprising representatives from the various groups and departments that generate the data and make decisions from it, spend many hours sourcing and assembling the necessary information. Those full-time equivalent (FTE) days spent searching for and compiling this data present a significant productivity challenge for project teams. For regulatory submission of a substance or product under development, there are many necessary steps. Initially, chemical
Reference 1 ‘How to Identify Critical Quality Attributes and Critical Process Parameters’, in FDA/ PQRI 2nd Conference, J. Maguire and D. Peng, North Bethesda, Maryland: US Food and Drug Administration, 6 October, 2015
Andrew Anderson is VP innovation and informatics strategy at ACD/Labs
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