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(a) There shall be considered a composed tests software intended to assess the stability characteristics of drug solutions. The effects of this kind of balance testing shall be Employed in deciding ideal storage problems and expiration dates. The prepared method shall be adopted and shall include:You will find a course of action of self-inspection
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(i) 3 months following the expiration date of the last lot of the drug products that contains the active ingredient if the expiration relationship duration of the drug product is thirty times or fewer; or ten. What's the satisfactory media fill frequency in relation to the amount of shifts? Generally, media fills must be repeated 2 times for every