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No white-out is permitted in GMP facilities and no gel pens (precise creating devices are specified in the SOPs and dealing Directions)• Defines technical specs and processes for all products and methods of manufacture and controlAns: The EMA draft guideline states “a minimum of 3 consecutive batches,” with justification being supplied
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Schuchardt and Berg [196] tailored the Washburn equation by assuming a linear lessen with time from the pore radius inside the wetted region of a porous medium (a composite of cellulose and superabsorbent fibres). They regarded as RThrough the disintegration test, the dosage variety is positioned in the right basket or paddle assembly and immersed