FDA Intel

21 CFR 211.111: Time limitations on production

Requires drug manufacturers to set time limits for completing each production phase when appropriate to protect product quality, and to justify and document any deviation, which is acceptable only if quality is not compromised.

Part 211, Current Good Manufacturing Practice for Finished Pharmaceuticals · Subpart F, Production and Process Controls

2%

of drug-manufacturing 483s since 2023 cite this section at least once

How FDA words it

The opening lines investigators use most when they cite 211.111, from the 483s we hold.

Time limits are not established when appropriate for the completion of each production phase to assure the quality of the drug product.Most used

Cited over time

483s citing 211.111, by year

Most citations in 2019. Bars are relative to the busiest year. *2026 to date.

Years shown: 2017 to 2026. The busiest year was 2019.

Recent 483s citing 211.111

See all 483s citing 211.111

The regulation text

§ 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.

Questions

What does 21 CFR 211.111 require?

Requires drug manufacturers to set time limits for completing each production phase when appropriate to protect product quality, and to justify and document any deviation, which is acceptable only if quality is not compromised.

How often is 211.111 cited in Form 483s?

It appears in about 2% of the drug-manufacturing 483s we hold from 2023 onward.

How do FDA investigators word a 211.111 observation?

The most common opening is: “Time limits are not established when appropriate for the completion of each production phase to assure the quality of the drug product.”

Which sections are cited alongside 211.111?

In the same 483s, investigators most often also cite 211.192 (Production record review), 211.22 (Responsibilities of quality control unit), 211.113 (Control of microbiological contamination), 211.42 (Design and construction features).