§ 211.111 Time limitations on production.
When appropriate, time limits for the completion of each phase of production shall be established to assure the quality of the drug product. Deviation from established time limits may be acceptable if such deviation does not compromise the quality of the drug product. Such deviation shall be justified and documented.
How BatchGlow handles this
A formula cannot be approved without its bulk hold time and shelf life, and equipment whose clean-hold time has run out is refused at line clearance.
What it asks for, in plain words
- 21 CFR 211.111
- When appropriate, time limits are set for finishing each phase of production. Going past one is acceptable only if quality is not compromised, and it is justified and documented.
These summaries are BatchGlow's reading of the text on this page, checked against it on 2 Oct 2026. The text governs.