CFR section
21 CFR 110.80(b)(15): Processes and controls
PART 110-CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKING, OR HOLDING HUMAN FOOD · Subpart E-Production and Process Controls
Key facts
| Citation | 21 CFR 110.80(b)(15) |
|---|---|
| Section | Processes and controls |
| Part | PART 110-CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKING, OR HOLDING HUMAN FOOD |
| Subpart | Subpart E-Production and Process Controls |
| Subchapter | 21 CFR B Food |
| Product types cited | Drugs, Food/Cosmetics, General |
| Regulation text (excerpt) | (15) Food such as, but not limited to, acid and acidified food, that relies principally on the control of pH for preventing the growth of undesirable microorganisms shall be monitored and maintained at a pH of 4.6 or below. Compliance with this requirement may be accomplished by any effective means, including employment of one or more of the following practices: (i) Monitoring the pH of raw materials, food in process, and finished food. (ii) Controlling the amount of acid or acidified food added… |
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About CFR sections cited by the FDA
Title 21 of the Code of Federal Regulations contains the FDA's regulations, including current good manufacturing practice and quality system requirements that inspections cite.