21 C.F.R. · Food and Drugs
21 C.F.R. § 820.250

Statistical techniques.

Title 21 C.F.R. ● ACTIVE Primary Source
Regulatory Text

21 C.F.R. § 820.250 — Statistical techniques.

§ 820.250 Statistical techniques. (a) Where appropriate, each manufacturer shall establish and maintain procedures for identifying valid statistical techniques required for establishing, controlling, and verifying the acceptability of process capability and product characteristics. (b) Sampling plans, when used, shall be written and based on a valid statistical rationale. Each manufacturer shall establish and maintain procedures to ensure that sampling methods are adequate for their intended use and to ensure that when changes occur the sampling plans are reviewed. These activities shall be documented.

Source: ecfr.gov · govinfo.gov — public domain Official Source ↗
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BS-CFR21-SEC-6C0F5B
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21 C.F.R. § 820.250
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The regulatory text of 21 C.F.R. § 820.250 is reproduced from the official Code of Federal Regulations as published by the Office of the Federal Register and the National Archives and Records Administration.
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boisestandard.org United States Law CFR Title 21 21 C.F.R. § 820.250