Glossary
Sampling Plan
A plan fixing in advance from which locations, how many, and how much to sample, together with the criteria for judging the result.
Details
The essential point is that the sampling locations, quantities, and acceptance criteria are fixed in advance; if the sample does not represent the population, every test result that follows loses its basis. Findings either bundle it into one sentence with specifications, standards, and test procedures as not established, or cite separately the fact that a plan already fixed was not followed. Because 21 CFR 211.165(c) and (d) require the number of units tested per batch and the statistical acceptance and rejection levels to be documented, what is examined is how the sample size was derived.
Related sections
Related terms
Real inspection findings
Findings from regulators' inspection documents in which this term appears.
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We acknowledge actions taken by your firm in response to your failure to establish statistically valid sampling plans as part of your visual inspection program.
FDA · FDA Warning Letter · 2025-12-02 -
Your laboratory sampling plans and testing methods were not scientifically sound.
FDA · FDA Warning Letter · 2022-06-07 -
You have not established scientifically sound and appropriate specifications, standards, sampling plans and test procedures to assure that your products conform to appropriate standards of identity, strength, quality, and purity.
FDA · FDA Warning Letter · 2021-08-17
Counted as of 2026-09-24 — the search you land on shows today's figures, so it may differ slightly.
Source
WHO Technical Report Series No. 929, Annex 4, WHO guidelines for sampling of pharmaceutical products and related materials, Glossary, Sampling planGRM Regulatory Glossary
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