One must be a partner in development rather than a supporter/service provider, and use scientific acumen to fast track the activities over popular shortcuts, commented Shitalkumar Pathak, VP – Analytical Research (Formulations), Glenmark Pharmaceuticals, while speaking at the ADL Conclave 2022.
He then spoke about the four pillars of analytical development: human resource (right hiring, placing right people for right job, continuous learning/adapting to new technologies); instrumentation (current trends… UPLC Vs HPLC, NIR, Raman); analytical procedures (smart and short methods, single method for multiple tests and QbD-based development) and material selection (columns, excipients and flavours).
He also talked about focus areas in F&D that include forced degradation studies: degradation pathways; particle size, shape and morphology, polymorphism, dissolution and reverse engineering. Regarding the overall role of analytical research, he said that it involves method development, process optimisation, stability studies, SPEC finalisation, method validation, analytical tech transfer and specification/STP. Apart from it, there are characterisation activities like nitrosamines, elemental IVRT/residual solvent risk assessment and reverse engineering. IP support, regulatory support and plant support are some other important factors that play a crucial role in analytical research, he concluded.
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