Free self-assessment · 12 questions · about 3 minutes

USP <797> inspection readiness self-assessment

Review twelve selected checks across five sterile-compounding operational areas. Your score, grade, and the USP <797> (2023) requirement behind each gap appear instantly. No login, nothing to download.

01

Environmental monitoring

Viable sampling, continuous conditions, and what happens when something goes out of range.

  1. Viable air and surface sampling are performed on the cadence your category requires (air at least every 6 months and surface at least monthly for Category 1 and 2; air at least monthly and surface at least weekly for Category 3), at every required location, with results compared against action levels.

  2. Temperature, humidity, and pressure differentials are logged continuously or documented at least once daily on days you compound, and someone reviews the record.

  3. Every excursion (an action-level CFU count, or an out-of-range temperature, humidity, or pressure reading) is investigated, with corrective action and follow-up sampling documented.

02

Cleaning and disinfection

Documented cadence, sporicidal application, and proof it worked.

  1. Daily cleaning and disinfection of the PEC, work surfaces, and floors in classified areas is documented every day compounding occurs, including the agent used, its lot, and the contact time.

  2. Monthly cleaning of walls, ceilings, and storage shelving is documented, a sporicidal disinfectant is applied on the required frequency, and cleaning effectiveness is verified.

03

Personnel

Garbing, gloved fingertip, and media fill on the Category 1/2/3 cadence, with records current.

  1. Every compounder has a current hand hygiene and garbing competency by direct visual observation: at least every 6 months for Category 1 and 2, every 3 months for Category 3.

  2. Gloved fingertip and thumb sampling and media-fill testing are current on the same cadence (6 months for Category 1 and 2, 3 months for Category 3), with results inside action levels.

  3. Training and competency records are complete, current, and retrievable per person, including initial training, every ongoing evaluation, and any restriction placed on someone who failed.

04

Facility and equipment

Engineering-control certification and calibration records with NIST traceability.

  1. Every PEC and SEC is certified on schedule (at least every 6 months) by a qualified certifier, the report is reviewed, and any deficiency is corrected and documented.

  2. Compounding and monitoring equipment (balances, refrigerators, freezers, incubators, sterilizers, and sensors) has current calibration or verification records, traceable to NIST standards where the instrument requires it.

05

Documentation

SOP control, CAPA, and how fast a record can be produced on request.

  1. SOPs cover every required activity, are version-controlled with an effective date and approval signatures, and were reviewed by the designated person within the last 12 months.

  2. A deviation and CAPA system is in active use, and any record can be retrieved within minutes for a date range an inspector names.

Full report

Email me the full report with what an inspector asks for at each gap

Your answers, score, and per-area breakdown, with the USP <797> requirement and suggested supporting records for every item you marked “No” or “Partial.”

We use your answers only to prepare the report. No spam, no list sharing. See our privacy policy.

This self-assessment is an informational screening tool based on the 2023 revision of USP <797>. It is not regulatory advice, a compliance determination, or a substitute for the official USP text, state board rules, or your facility’s designated person. Category 3 facilities and USP <800> hazardous drug handling carry additional requirements not scored here.

Inspection readiness FAQs

What does an FDA or state board inspector look for in a USP <797> inspection?

Inspectors verify that the facility can demonstrate, with records, that it meets USP <797>: viable air and surface sampling on the cadence for its category, temperature, humidity, and pressure documented at least daily on compounding days, cleaning and sporicidal logs, personnel garbing, gloved fingertip, and media-fill competencies current, engineering controls certified within the interval, calibrated equipment, current SOPs, and a working deviation and CAPA process. The actual scope depends on the regulator, facility and activities; records alone do not establish that practices are adequate.

How often must personnel be requalified under USP <797> (2023)?

Hand hygiene and garbing observation, gloved fingertip and thumb sampling, and media-fill testing are performed initially and then at least every 6 months for Category 1 and Category 2 compounding, and at least every 3 months for Category 3. Personnel whose role is oversight only requalify at least every 12 months. Core knowledge evaluation has a separate interval; check each component and role against the official chapter.

How often must viable air and surface sampling be performed?

Category 1 and Category 2 facilities perform viable air sampling at least every 6 months and viable surface sampling at least monthly. Category 3 facilities perform viable air sampling at least monthly and viable surface sampling at least weekly, and also sample PEC surfaces at the end of every batch before cleaning. Both categories sample again after any event that could affect air quality. Action levels are ISO 5 >1 · ISO 7 >10 · ISO 8 >100 CFU/m³ for air and ISO 5 >3 · ISO 7 >5 · ISO 8 >50 CFU/plate for surfaces.

How often must a PEC or cleanroom be certified?

Primary and secondary engineering controls are certified initially and at least every 6 months, and again whenever a change is made that could affect air quality, such as relocating a hood, replacing a HEPA filter, or modifying the HVAC. Non-viable particle counts are performed at least every 6 months as part of that certification.

How is this self-assessment scored?

Each of the 12 questions carries equal weight. A "Yes" earns full credit, "Partial" earns half, and "No" earns none. The total is scaled to 0 to 100 and mapped to a letter grade using the same thresholds CompliRx uses in the product: A at 90 or above, B at 80, C at 70, D at 60, and F below 60. These are CompliRx screening thresholds, not USP or FDA grades, and the score is not validated to predict inspection findings. A high score can coexist with a serious issue outside these selected checks.

Related: BUD calculator · Media fill · USP <797> compliance software

Sources and how to use your results

Compare each answer with the official USP <797> chapter resources and USP FAQs, plus your state board requirements. FDA explains the separate 503A and 503B oversight frameworks. This checklist does not cover every obligation under either pathway.

For each gap, identify an owner, the record to retrieve, the actual operating condition and a follow-up date. Use the personnel competency guide, environmental monitoring review and CAPA workflow for focused follow-up. Complete the inspection preparation review before treating this screening exercise as evidence of readiness.

Close the gaps before the inspector finds them.

CompliRx keeps environmental monitoring, cleaning, personnel competency, certification, SOPs, and CAPA evidence in one inspection-ready record, piloted for $399/month.