§211.170. Reserve samples. — Inbound Citations
21 C.F.R. § 211.170
Statutory Authority
Cited by 2 regulations in release Current.
Citations to 21 C.F.R. § 211.170 as a whole
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(viii) Section 211.170 of this chapter. Reserve samples.
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(b) Representative samples of each shipment of each lot shall be collected for testing or examination. The number of containers to be sampled, and the amount of material to be taken from each container, shall be based upon appropriate criteria such as statistical criteria for component variability, confidence levels, and degree of precision desired, the past quality history of the supplier, and the quantity needed for analysis and reserve where required by § 211.170.