21 CFR § 4.2 - How does FDA define key terms and phrases in this subpart?
The terms listed in this section have the following meanings for purposes of this subpart:
Combination product has the meaning set forth in § 3.2(e) of this chapter.
Co-packaged combination product has the meaning set forth in § 3.2(e)(2) of this chapter.
Current good manufacturing practice operating system means the operating system within an establishment that is designed and implemented to address and meet the current good manufacturing practice requirements for a combination product.
Current good manufacturing practice requirements means the requirements set forth under § 4.3(a) through (d).
Drug CGMPs refers to the current good manufacturing practice regulations set forth in parts 210 and 211 of this chapter.
HCT/Ps refers to human cell, tissue, and cellular and tissue-based products, as defined in § 1271.3(d) of this chapter. An HCT/P that is not solely regulated under section 361 of the Public Health Service Act may be a constituent part of a combination product. Such an HCT/P is subject to part 1271 of this chapter and is also regulated as a drug, device, and/or biological product.
Manufacture includes, but is not limited to, designing, fabricating, assembling, filling, processing, testing, labeling, packaging, repackaging, holding, and storage.
QS regulation refers to the quality system regulation in part 820 of this chapter.
Single-entity combination product has the meaning set forth in § 3.2(e)(1) of this chapter.