Michael Barbush - Comment

Combination products that are provided as a single-entity or are co-packaged are many and varied. At the opposite end of the spectrum from products like drug eluting stents are less complex combinations such as prefilled drug syringes or kits containing a drug vial and a delivery device. The proposed rule specifies that if the kit is manufactured to cGMP the manufacturer should carefully consider QS requirements for design controls, purchasing controls, and corrective and preventative actions (CAPA). Purchasing controls and CAPA are consistent with cGMP and may already be considered by many drug manufactures. Design controls, however, appear less appropriate in cases where the device component is purchased and used unchanged from the regular stock of the device manufacturer who is responsible for maintaining design controls for the device. Requiring the cGMP drug manufacturer to implement design controls in these instances would be akin to requiring a GMP drug manufacturer to provide additional supplier controls on a vial of Water For Injection, purchased from another cGMP drug supplier for inclusion in a kit with a lyophilized drug. We propose that the requirement for careful consideration of design controls in a cGMP manufacturing operation be deleted or simplified for combination product kits in which the device component of the kit is used or packaged as received from the supplier without modification of its design.