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U.S. Department of Health and Human Services

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Volume I - 5.7 Sampling Operations

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ORA Laboratory Policies

Food and Drug Administration

DOCUMENT NO.:
ORA-LAB.QM

VERSION NO.:2.0

ORA Laboratory Manual of Quality Policies

EFFECTIVE DATE:
10-01-03
REVISED:
05-02-14

5.7.1 Procedure

ORA laboratories do not routinely perform sampling in the sense of collecting a representative sample from a product lot to represent the whole.

Sample Collection Conducted by the Customer: Most test samples are obtained and sent to the laboratory by ORA inspectional staff. Instructions for sample collection by such personnel are provided in the Investigations Operations Manual (IOM). Occasionally, laboratory personnel are consulted about sampling parameters such as sample type or size or guidance for a particular sampling or analytical need. The ORA laboratories, however, exert no direct control over such sampling and do not have responsibility for sampling.

Sampling conducted by ORA laboratories involves for the most part those analyses that call for a portion or aliquot of the total sample received by the laboratory to be analyzed. Generally, this calls for mixing or preparing of samples to assure homogeneity before portions are taken for analysis. Sample preparation and subsampling protocols are found in the analytical methods, compliance programs, and assignments.

Related Procedures