For the purpose of this subpart:
(a)
Fermentation means process operations that utilize a chemical change induced by a living organism or enzyme, specifically, bacteria, or the microorganisms occurring in unicellular plants such as yeast, molds, or fungi to produce a specified product.
(b)
Product means pharmaceutical products derived from fermentation processes.
Code of Federal Regulations
[68 FR 12271, Mar. 13, 2003]
For the purpose of this subpart:
(a)
Fermentation means process operations that utilize a chemical change induced by a living organism or enzyme, specifically, bacteria, or the microorganisms occurring in unicellular plants such as yeast, molds, or fungi to produce a specified product.
(b)
Product means pharmaceutical products derived from fermentation processes.
Code of Federal Regulations
[68 FR 12271, Mar. 13, 2003]