FDA Intel

21 CFR 211.105: Equipment identification

Requires manufacturers to label all containers, processing lines, and major equipment with their contents and processing phase, and to record each major equipment's unique ID (or name if only one exists) in batch records.

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

How FDA words it

The opening lines investigators use most when they cite 211.105, from the 483s we hold.

All major equipment used during the production of a batch of drug product is not properly identified at all times to indicate contents.Most used
All compounding and storage containers used during the production of a batch of drug product is not properly identified at all times to indicate contents.211.105(a)
All processing lines and major equipment used during the production of a batch of drug product is not properly identified at all times to indicate contents and the phase of processing of the batch.211.105(a)

Cited over time

483s citing 211.105, by year

Most citations in 2023. Bars are relative to the busiest year. *2026 to date.

Years shown: 2017 to 2026. The busiest year was 2023.

Recent 483s citing 211.105

See all 483s citing 211.105

The regulation text

§ 211.105 Equipment identification.

(a)All compounding and storage containers, processing lines, and major equipment used during the production of a batch of a drug product shall be properly identified at all times to indicate their contents and, when necessary, the phase of processing of the batch.

(b)Major equipment shall be identified by a distinctive identification number or code that shall be recorded in the batch production record to show the specific equipment used in the manufacture of each batch of a drug product. In cases where only one of a particular type of equipment exists in a manufacturing facility, the name of the equipment may be used in lieu of a distinctive identification number or code.

Questions

What does 21 CFR 211.105 require?

Requires manufacturers to label all containers, processing lines, and major equipment with their contents and processing phase, and to record each major equipment's unique ID (or name if only one exists) in batch records.

How do FDA investigators word a 211.105 observation?

The most common opening is: “All major equipment used during the production of a batch of drug product is not properly identified at all times to indicate contents.”

Which sections are cited alongside 211.105?

In the same 483s, investigators most often also cite 211.192 (Production record review), 211.100 (Written procedures; deviations), 211.67 (Equipment cleaning and maintenance), 211.22 (Responsibilities of quality control unit).