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Short answer
USP <790> is the United States Pharmacopeia general chapter on visible particulates in injections. It says every product intended for parenteral administration must be visually inspected for particulate matter, and it defines what it means for an injection to be “essentially free” of visible particulates. It is a compendial standard, not the whole of what FDA expects: FDA’s draft guidance says meeting a USP compendial standard alone is not generally sufficient for current good manufacturing practice (CGMP).
Definition and scope of USP <790>
The chapter is titled Visible Particulates in Injections. Its opening requirement is that all products intended for parenteral administration are visually inspected for the presence of particulate matter. The chapter relies on the companion chapter <788> Particulate Matter in Injections for the underlying definition: particulate matter is extraneous, mobile, undissolved particles, other than gas bubbles, that are unintentionally present in solutions. The examples the USP preview gives are fibers, glass, metal, elastomeric materials and precipitates.
“Essentially free” is the chapter’s working standard. It means that no more than a specified number of units show visible particulates when inspected as the chapter describes. The acceptance numbers and inspection parameters sit in the full chapter text, which USP publishes to subscribers through the USP-NF. A quality unit should work from the current official text for those numbers.
How it is used in practice
In practice the chapter turns a general expectation (“injections should be free of visible particles”) into a defined inspection outcome that a manufacturer, a contract laboratory and a purchaser can all refer to by name. FDA frames the wider job more broadly. Its draft guidance, Inspection of Injectable Products for Visible Particulates (CDER, CBER and CVM, December 2021, docket FDA-2021-D-0241), describes a holistic, risk-based approach that runs through product development, manufacturing controls, visual inspection, particulate identification, investigation and corrective actions. Visual inspection is one control point in that chain, not the entire programme.
Visible, subvisible and inherent particles
Three distinctions prevent most scope errors.
Visible versus subvisible
USP <790> addresses what can be seen on inspection. FDA’s draft guidance states plainly that it does not cover subvisible particulates, so a team looking for subvisible limits needs a different source than either document discussed here.
Extraneous versus inherent
The chapter notes that some products may contain inherent particles or agglomerates. For those, the product monograph or the approved regulatory application sets the requirements. The control and acceptance criteria for extraneous particles still apply.
Compendial versus regulatory expectation
The chapter is a USP standard. FDA’s guidance is a separate, non-binding statement of regulatory thinking, and it is a draft: the FDA page carries the label “Not for implementation. Contains non-binding recommendations.” (status as of 2026-10-29).
| Question | USP <790> | FDA draft guidance |
|---|---|---|
| Core statement | All parenteral products must be visually inspected for particulate matter | Visible particulates in injectables can jeopardize patient safety |
| Approach | Defines “essentially free” of visible particulates | Holistic, risk-based control from development through corrective actions |
| Subvisible particulates | Chapter title and opening requirement concern visible particulates | Not covered |
| Inherent particles | Monograph or approved application sets requirements; extraneous-particle criteria still apply | Guidance summary does not mention them |
| Standing | Compendial chapter | Draft, non-binding; compendial compliance alone is generally not sufficient for CGMP |
Where it matters for labs, clinics and supply decisions
The USP preview names the particle types that count as extraneous: fibers, glass, metal, elastomeric materials and precipitates. FDA’s draft guidance names the stages at which visible-particulate control should be considered: product development, manufacturing controls, visual inspection, particulate identification, investigation and corrective actions. A useful review question for each named particle type is whether the supplier’s quality system covers it at each of those stages, not only at the final inspection.
The practical consequence is that a supplier statement of “meets USP <790>” answers one question about inspection outcome. FDA’s draft guidance expects the underlying particulate control, identification and investigation work to exist as well. For the surrounding facility context, see the guides on cGMP facility requirements, EU GMP Annex 1 sterile manufacturing, aseptic process simulation and the GMP audit checklist.
Common misunderstandings
“Essentially free” does not mean zero particles in every unit
The chapter’s wording is that no more than a specified number of units show visible particulates under the described inspection. It is a defined outcome, not a promise about each vial.
Passing the chapter is not the same as meeting CGMP
FDA’s draft guidance states that meeting an applicable USP compendial standard alone is not generally sufficient for CGMP.
The chapter does not cover subvisible particles
FDA’s draft guidance on visible particulates expressly excludes subvisible particulates, so the two are treated as separate questions.
USP does not enforce the chapter
USP has no role in enforcing its standards, a point stated on the Beckman Coulter USP <790> resource page.
FAQ
What is USP 790?
USP <790> is the USP-NF general chapter Visible Particulates in Injections. It requires visual inspection of parenteral products for particulate matter and defines “essentially free” of visible particulates.
Does USP 790 cover subvisible particles?
No. It addresses visible particulates. The chapter relies on <788> Particulate Matter in Injections for its definition of particulate matter, and FDA’s draft guidance on visible particulates also excludes subvisible particulates.
Is USP 790 enough to satisfy FDA?
FDA’s draft guidance says meeting an applicable USP compendial standard alone is not generally sufficient for CGMP, and it recommends a risk-based approach across the product lifecycle.
Sources
- USP-NF, General Chapter <790> Visible Particulates in Injections, preview page: https://doi.usp.org/USPNF/USPNF_M7197_01_01.html (checked 2026-10-29).
- U.S. FDA, Inspection of Injectable Products for Visible Particulates, draft guidance, December 2021: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/inspection-injectable-products-visible-particulates (checked 2026-10-29).
- Beckman Coulter, USP <790> industry standards resource (vendor page, context only): https://www.beckman.com/resources/industry-standards/usp-790 (checked 2026-10-29).
