21 C.F.R. § 158.3

Current through September 30, 2024
Section 158.3 - Definitions

For the purposes of this part the following definitions shall apply:

(a)Lot. A collection of primary containers or units of the same size, type and style manufactured or packed under similar conditions and handled as a single unit of trade.
(b)Lot size. The number of primary containers or units (pounds when in bulk) in the lot.
(c)Sample size. The total number of sample units drawn for examination from a lot.
(d)Sample unit. A container, a portion of the contents of a container, or a composite mixture of product from small containers that is sufficient for the examination or testing as a single unit.
(e)Defective. Any sample unit shall be regarded as defective when the sample unit does not meet the criteria set forth in the standards.
(f)Acceptance number. The maximum number of defective sample units permitted in the sample in order to consider the lot as meeting the specified requirements. The following acceptance numbers shall apply:

Lot size (primary container)Size container
n1c2
NET WEIGHT EQUAL TO OR LESS THAN 1 KG (2.2 LB)
4,800 or less132
4,801 to 24,000213
24,001 to 48,000294
48,001 to 84,000486
84,001 to 144,000849
144,001 to 240,00012613
Over 240,00020019
NET WEIGHT GREATER THAN 1 KG (2.2 LB)
Number of Pounds
20,000 or less132
More than 20,000 to 100,000213
More than 100,000 to 200,000294
More than 200,000 to 400,000486
More than 400,000 to 600,000849
More than 600,000 to 1,000,00012613
More than 1,000,00020019

1n = number of sample units.

2c = acceptance number.

(g)Acceptable quality level (AQL). The maximum percent of defective sample units permitted in a lot that will be accepted approximately 95 percent of the time.

21 C.F.R. §158.3

42 FR 14461, Mar. 15, 1977