CFR section
21 CFR 226.58(e): Laboratory controls
PART 226-CURRENT GOOD MANUFACTURING PRACTICE FOR TYPE A MEDICATED ARTICLES · Subpart C-Product Quality Control
Key facts
| Citation | 21 CFR 226.58(e) |
|---|---|
| Section | Laboratory controls |
| Part | PART 226-CURRENT GOOD MANUFACTURING PRACTICE FOR TYPE A MEDICATED ARTICLES |
| Subpart | Subpart C-Product Quality Control |
| Subchapter | 21 CFR C Drugs General |
| Product types cited | Drugs |
| Regulation text (excerpt) | (e) Adequate provision to check the reliability, accuracy, and precision of any laboratory test procedure used. The official methods in “Methods of Analysis of the Association of Official Analytical Chemists,”[1] methods described in an official compendium, and any method submitted as a part of a food additive petition or new-drug application that has been accepted by the Food and Drug Administration shall be regarded as meeting this provision. |
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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.