CFR section
21 CFR 211.105(b): Equipment identification
PART 211-CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS · Subpart F-Production and Process Controls
Key facts
| Citation | 21 CFR 211.105(b) |
|---|---|
| Section | Equipment identification |
| Part | PART 211-CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS |
| Subpart | Subpart F-Production and Process Controls |
| Subchapter | 21 CFR C Drugs General |
| Product types cited | Biologics, Devices, Drugs, Food/Cosmetics, Other_Regulations |
| Regulation text (excerpt) | (b) Major equipment shall be identified by a distinctive identification number or code that shall be recorded in the batch production record to show the specific equipment used in the manufacture of each batch of a drug product. In cases where only one of a particular type of equipment exists in a manufacturing facility, the name of the equipment may be used in lieu of a distinctive identification number or code. |
At a glance
- 100–999 Inspections citing this section
- 10–99 Warning letters citing this section
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
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.