§4.3. What current good manufacturing practice requirements apply to my combination product? — Inbound Citations
21 C.F.R. § 4.3
Statutory Authority
Cited by 8 regulations in release Current.
Citations to 21 C.F.R. § 4.3 as a whole
-
(1) The specifics of each set of current good manufacturing practice regulations listed under § 4.3 as they apply to each constituent part included in the combination product; or
Citations to §4.3(a)
-
The terms listed in this section have the following meanings for purposes of this subpart:
Citations to §4.3(b)
-
The terms listed in this section have the following meanings for purposes of this subpart:
Citations to §4.3(c)
-
The terms listed in this section have the following meanings for purposes of this subpart:
-
(4) In addition to being shown to comply with the other applicable manufacturing requirements listed under § 4.3, if the combination product includes a biological product constituent part, the current good manufacturing practice operating system must also be shown to implement and comply with all manufacturing requirements identified under § 4.3(c) that would apply to that biological product if that constituent part were not part of a combination product.
Citations to §4.3(d)
-
The terms listed in this section have the following meanings for purposes of this subpart:
-
(5) In addition to being shown to comply with the other applicable current good manufacturing practice requirements listed under § 4.3, if the combination product includes an HCT/P, the current good manufacturing practice operating system must also be shown to implement and comply with all current good tissue practice requirements identified under § 4.3(d) that would apply to that HCT/P if it were not part of a combination product.
Citations to §4.3(e)
-
The terms listed in this section have the following meanings for purposes of this subpart: