FDA Adds Device Scenarios to Final GMP Guidance for Combo Products

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In the finalized guidance on GMP requirements for combination product manufacturers, the FDA clarified how to comply with certain device requirements with compliance examples for prefilled syringes, drug-coated mesh and drug-eluting stents. This final version reiterates that combination product manufacturers have two options for compliance: satisfy all drug and device GMPs, or implement a streamlined quality system that focuses primarily on one but incorporates elements of the other GMP systems. This guidance details which GMPs are applicable to a product, general methods for how to implement them, key definitions, and how to make post-market changes to a product’s quality system. 

Read the guidance here.