CFR — Code of Federal Regulations Title 21 Part 211 Subpart F – Production and Process Controls § 211.105 – Equipment identification.

[Code of Federal Regulations]
[Title 21, Volume 4]
[CITE: 21CFR211.105]

TITLE 21–FOOD AND DRUGS
CHAPTER I–FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER C – DRUGS: GENERAL
PART 211 — CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS

Subpart F – Production and Process Controls

Sec. 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.

As per US Health & Human Services, the information on this page is current as of Mar. 22, 2024.