Why 211 How it works The pilot What it is Regulations

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Why 211 How it works The pilot What it is Regulations Become a pilot site

Regulations
21 CFR Part 211
Subpart A—General Provisions
21 CFR 211.3

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§ 211.3 Definitions.

Law · 21 CFR 211.3 · eCFR as of 25 Sep 2026 · checked 30 Sep 2026 · Official source: ecfr.gov

The definitions set forth in § 210.3 of this chapter apply in this part.

The batch record these sections ask for, kept while the batch runs.

BatchGlow is batch manufacturing software for contract manufacturers running cosmetics and OTC monograph products side by side. It is pre-release, and taking three pilot sites; you would work directly with the person writing the code.

Become a pilot site See what it enforces

←§ 211.1 Scope.§ 211.22 Responsibilities of quality control unit.→

The batch record these sections ask for, kept while the batch runs.

BatchGlow is batch manufacturing software for contract manufacturers running cosmetics and OTC monograph products side by side. It is pre-release, and taking three pilot sites; you would work directly with the person writing the code.

Become a pilot site See what it enforces

BatchGlow

ERP, MES and batch records for cosmetics and OTC manufacturers.

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The texts on these pages are works of the U.S. Government, which are not subject to copyright (17 U.S.C. 105), copied from the official source named on each page; the official source governs. They are given for reference and are not legal advice. BatchGlow is manufacturing and quality software for contract manufacturers of cosmetics and OTC drugs; it supports compliance and does not confer it.

© 2026 BatchGlow · Built by Sergey Belii

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