§ 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.

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What FDA inspectors cite under § 211.105

Form FDA 483 observations citing this section, fiscal years 2009–2026 (Drugs).

• Distinctive ID or code not recorded in batch record 69
• Identification of containers, lines, equipment 64

FDA guidance that cites § 211.105

• BLA for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic and Immunologic Reconstitution in Patients with Disorders Affecting the Hematopoietic System: Guidance for Industry 1 Mar 2014

Amendment history

Federal Register documents that created or amended this section.

• 43 FR 45077 29 Sept 1978