CFR section
21 CFR 226.102(a)(4): Master-formula and batch-production records
PART 226-CURRENT GOOD MANUFACTURING PRACTICE FOR TYPE A MEDICATED ARTICLES · Subpart E-Records and Reports
Key facts
| Citation | 21 CFR 226.102(a)(4) |
|---|---|
| Section | Master-formula and batch-production records |
| Part | PART 226-CURRENT GOOD MANUFACTURING PRACTICE FOR TYPE A MEDICATED ARTICLES |
| Subpart | Subpart E-Records and Reports |
| Subchapter | 21 CFR C Drugs General |
| Product types cited | Drugs |
| Regulation text (excerpt) | (4) Manufacturing instructions for each type of Type A medicated article(s) produced on a batch or continuous operation basis, including mixing steps and mixing times that have been determined to yield an adequately mixed Type A medicated article(s); and in the case of Type A medicated article(s) produced by continuous production run, any additional manufacturing directions including, when indicated, the settings of equipment that have been determined to yield an adequately mixed Type A… |
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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.