FDA 发布注射剂可见颗粒物检查指南草案并征求意见

GUIDANCE DOCUMENT

Inspection of Injectable Products for Visible Particulates Draft Guidance for Industry December 2021

Draft Level 1 Guidance

Not for implementation. Contains non-binding recommendations.

Docket Number:

FDA-2021-D-0241

Issued by:

Guidance Issuing Office

Center for Drug Evaluation and Research

Center for Biologics Evaluation and Research

Center for Veterinary Medicine

Visible particulates in injectable products can jeopardize patient safety. This guidance addresses the development and implementation of a holistic, risk-based approach to visible particulate control that incorporates product development, manufacturing controls, visual inspection techniques, particulate identification, investigation, and corrective actions designed to assess, correct, and prevent the risk of visible particulate contamination. The guidance also clarifies that meeting an applicable United States Pharmacopeia (USP) compendial standard alone is not generally sufficient for meeting the current good manufacturing practice (CGMP) requirements for the manufacture of injectable products. The guidance does not cover subvisible particulates or physical defects that products are typically inspected for along with inspection for visible particulates (e.g., container integrity flaws, fill volume, appearance of lyophilized cake/suspension solids).

Submit Comments

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2021-D-0241.