CFR section
21 CFR 606.60(b): Equipment
PART 606-CURRENT GOOD MANUFACTURING PRACTICE FOR BLOOD AND BLOOD COMPONENTS · Subpart D-Equipment
Key facts
| Citation | 21 CFR 606.60(b) |
|---|---|
| Section | Equipment |
| Part | PART 606-CURRENT GOOD MANUFACTURING PRACTICE FOR BLOOD AND BLOOD COMPONENTS |
| Subpart | Subpart D-Equipment |
| Subchapter | 21 CFR F Biologics |
| Product types cited | Biologics, Drugs, Other_Regulations |
| Regulation text (excerpt) | (b) Equipment that shall be observed, standardized and calibrated with at least the following frequency, include but are not limited to: Equipment Performance check Frequency Frequency of calibration Temperature recorder Compare against thermometer Daily As necessary. Refrigerated centrifuge Observe speed and temperature Each day of use Do. Hematocrit centrifuge Standardize before initial use, after repairs or adjustments, and annually. Timer every 3 mo. General lab centrifuge Tachometer every 6… |
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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.