Pharmacy Inspection Podcast

The learning objectives for this week's 483: Explain the typical out of specification range of potency for many compounded formulations Discuss a type of testing that is both economical and scientifically sound Discuss the 5 elements of an SOP on potency testing should include This week we'll be looking at one observation the FDA made at a facility concerning the potency testing of their drug products. While there's not much direction given to pharmacies through USP Chapter , there's still a need for testing this critical attribute of our preparations. In fact, doesn't give us any requirements for testing for potency or the interval at which we should test our preparations. USP Chapter , Stability considerations in dispensing practice, only helps us look for signs of chemical instability (i.e. potency) but still gives us no interval to guide the frequency of potency testing that should be performed. USP Chapter says: Pharmacists should avoid ingredients and conditions that could result in