CFR > Title 40 - Protection of Environment > CHAPTER I—ENVIRONMENTAL PROTECTION AGENCY > SUBCHAPTER N—EFFLUENT GUIDELINES AND STANDARDS (Parts 400–471) > PART 439—PHARMACEUTICAL MANUFACTURING POINT SOURCE CATEGORY > SUBPART A—Fermentation Products (§439.10 to §439.17) > 439.11—Special definitions.

439.11—Special definitions.

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]