Product manufacturing information (PMI) helps the manufacturing industry transition to digitalization and automate taking a product from design to production to inspection. Known or potential incompatibilities (e.g. lactose with drug substance containing major amine) needs to be mentioned and the controls to attenuate the impact of these potential incompatibilities must be identified (e.g. management of impurities, bodily separation by way of manufacturing methods).
Moreover, specific attributes (CQAs) of the drug substance that may be affected by manufacturing circumstances and consequently have an impact on the drug product CQAs must be identified (e.g. assay and impurities CQAs due to sensitivity of the drug substance to light, heat, moisture or atmosphere).
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The data to be submitted will rely on the controls and characterization of the botanical materials, nevertheless it might be essential to doc all processing steps after harvesting (e.g. drying gear and time, treatment of plant materials (e.g. solvent extraction, pesticides)) to justify controls.
An API starting materials is proposed by the applicant and assessed by Well being Canada to determine whether or not the controls on the drug substance (e.g. impurities) and drug substance manufacturing process (e.g. control technique, important course of controls, intermediate testing) can present applicable control of high quality.