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U.S. Department of Health and Human Services

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Volume III - 7.2 Sampling

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Other Laboratory Operations

Food and Drug Administration

DOCUMENT NO.:

III-07

VERSION NO.:1.4

Section 7 – Private Laboratory Guidance

EFFECTIVE DATE: 10/01/2003REVISED: 01/30/13

Sampling for analysis is to represent the lot.  If, in the judgment of the reviewing office, the method of collection does not result in a representative sample, the analytical package should be rejected.  Sampling should be performed in conformance with FDA-recommended sampling procedures and Compliance Programs. (www.fda.gov/ora/cpgm  and Investigations Operations Manual, Ch. 4 www.fda.gov/ora/inspect_ref/iom/iomtc.html )

The sampler properly collects, identifies, and maintains samples from the time they are collected until they are delivered to the private laboratory. The sampler should:

  • verify the location and identity of the lot to be sampled;
  • collect samples following FDA sampling guidelines or other equivalent, established guidelines;
  • ensure the integrity of the sample (avoid contamination, maintain sterility or storage temperature, and take other measures as needed to protect the integrity of the sample);
  • identify the containers from which samples are collected with the FDA sample number or the U.S. Customs Service entry number;
  • prepare and ship the sample using precaution to prevent contamination and maintain sample integrity; and
  • complete a collection report for each sample collected that documents sample collection methods, sample preparation techniques, lot size and identification number, sample size, identity of the sample collector, statement from the collector of any observations about the lot, containers, etc., and description of chain of custody of the sample.

If the method of collection does not result in a representative sample, the analytical package is considered unacceptable.

Attachment 1 is a suggested form for a collection report.