FDAnews Management Report: The Essential Guide to Combination Products cGMPs
Because combination products blur the lines among drugs, biologics and devices, the challenge is determining which rules take precedence — drug GMP rules or device QSR rules. These two regulations are similar, but where they differ, you must take extra steps to ensure both rules are complied with. And numerous variables come into play when deciding which rules apply in which circumstances, such as:
In each case, you must determine how to apply the regulations before, during and after the component drug and device products are brought together in the manufacturing process. The FDA has tried to create a clearer path to compliance via its so-called “streamlined approach” to the GMPs. But significant issues remain.
Look to The Essential Guide to Combination Products cGMPs to discover:
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Posted in: News Briefs | November 19, 2015
Posted in: News Briefs | March 6, 2014