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What is the differance Between Calibration & Validation
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Answer Posted / anand patel
VALIDATION;A documented program that provides a high degree of
assurance that a specific process, method, or system will
consistently produce a result meeting pre-determined
acceptance criteria.
validation carried out for system process and method.
by validation we make a specification where as in calibration we are use specification for the cross verification.
calibration carried out on instrument
Calibration
The demonstration that a particular instrument or device
produces results within specified limits by comparison with
those produced by a reference or traceable standard over an
appropriate range of measurements.
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Anyone have any idea when to conduct Uniformity of Weight (UOW) and when need to conduct Uniformity of Dosage Units (UOD) or when need both? I read BP it only said if average weight < or = 0.04g then just conduct UOD, no need UOW. Under UOD section, it doesnt say when need to conduct UOD but just said UOD got two type, one is Mass Variation (MV), another is Content Uniformity (CU) and under what conditions to conduct them. For USP, no UOW section, only got UOD section.
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