PharmaOpps (Operation and Opportunity)’s Post

Sterile Operation-Q5: What is the meaning of difficult to inspect product (DIP): Response: There are dosage forms for which the sensitivity of direct examination is significantly reduced. The products hinder or block the inspector’s ability to reliably detect visible particulate matter. E.g. product with opaque or deeply colored solution, lyophilized cake, powders, concentrated suspensions, emulsions and ointments. Example of DIP containers includes translucent or opaque plastic, blow fill seal and flexible bags, foiled containers, plastic syringes and specialty containers such as cartridge and combination product.

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