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OMB MEETING MATERIALS

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Straw Man: This document is a starting point for future drafts and is not an approved document. Please do not distribute to laboratory staff for use.

Table 1. Calibration and verification of equipment or systems

Equipment /System

Action

Frequency

Water used for pharmaceutical analyses

Meet FDA Inspection Technical Guide Requirements: https://www.fda.gov/ICECI/Inspecti ons/InspectionGuides/InspectionTec hnicalGuides/ucm072925.htm

THE 8 TYPES OF WATER ARE:

1. Non-potable 2. Potable (drinkable) water 3. USP purified water 4. USP water for injection (WFI) 5. USP sterile water for injection 6. LUSP sterile water for inhalation 7. USP bacteriostatic water for injection 8. USP sterile water for irrigation

Every 5 years C

Weights, reference

Calibrate mass

Weights, working

Verify mass against reference weights

Annually

Notes:

A: Uniformity may not be needed for low capacity equipment. For example, a small muffle furnace with less than 1 ft 3 capacity may be too small to detect variability. In these cases, the laboratory should have documented justification for not determining uniformity.

08/09/2018