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Would this pass a GMP inspection?

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IQ/OQ — Autoclave 02
Would this IQ/OQ documentation survive an EU-GMP inspection?

Not as it stands. Three findings, most serious first:

Critical

OQ acceptance criteria are ticked as met while the measurement columns are empty (protocol, page 14).

Major

Requalification was due in March 2026 and no record follows; the calibration certificate on file expired in May.

Other

Template placeholder text remains in section 5.2.

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Conversations on the left, the Inspector in the middle, your documents on the right. Findings shown are illustrative.

Stored in Frankfurt

Private to your account, never added to the knowledge base.

Never used for training

Processed under terms that exclude training on your data.

A qualified person signs off

No score, no certificate, no approval. Decision support only.

Prices published

What it costs is on this page, not behind a sales call.

How it works

Three steps, the same afternoon.

  1. Step 1

    Upload what an inspector would see

    Qualification files, SOPs, calibration certificates, facility documents. PDF or Word, scans included. Each document shows exactly how it takes part in the review.

  2. Step 2

    Ask the Inspector

    “Would this pass an EU-GMP inspection?” “What is missing from this IQ/OQ/PQ?” Answers cite the document and the page, and say plainly what was not checked.

  3. Step 3

    Download the Gap Report

    A formal PDF: findings classed critical, major and other, each with the affected document, the regulatory reference and the recommended action. Ready for your qualified person to review and sign.

Sample Gap Report

What you get back.

A redacted sample, composed from the findings that come up in real reviews. The PDF you download has exactly this structure: the qualified-person banner, the overall assessment, every finding with its class, the affected document and page, the regulatory reference and the recommended action, then what is still open and which documents were and were not read.

Gaptria

GMP audit readiness

Sample, redacted

Gap Report

Generated
12 September 2026
Facility
██████████ (redacted), medicinal cannabis producer
Target certification
EU-GMP

Decision-support document. Findings must be reviewed and signed by a qualified person before use.

Overall assessment

Would not pass as it stands. One critical finding on its own would put the qualification of autoclave AC-02 in question, and the two major findings sit in the same area: the OQ is unexecuted where it matters, overdue for repeat, and measured with a reference whose status is unknown. The documentation system itself looks orderly; the gaps are in execution and calibration control, and all of them are closable before an inspection with a few weeks of work.

Findings (5 total: 1 critical, 2 major, 2 other)

Severity follows the EU-GMP inspection deficiency classification: critical, major, other.

Critical

OQ acceptance criteria ticked as met while the measurement columns are empty

Affected
IQ/OQ protocol, autoclave AC-02, section 7.3, page 14
Reference
EU-GMP Annex 15, section 3 (Operational Qualification); Chapter 4 (Documentation)

The temperature-distribution test is marked "complies" but no readings, no probe identifiers and no test time are recorded. An inspector cannot tell whether the test was run, and neither can you. Without data, the OQ is not executed and the equipment is not qualified.

Recommended action. Repeat the test with a calibrated reference, record every reading on the page, and open a deviation for the original blank execution rather than filling the columns in afterwards.

Major

Requalification interval not reconciled; the repeat OQ is overdue

Affected
IQ/OQ protocol section 9, page 19; Validation Master Plan rev 3, section 6
Reference
EU-GMP Annex 15, section 3.14 (re-qualification) and the site's Validation Master Plan

The manufacturer's protocol states an annual OQ, the site plan states two years, and nothing records which one applies. On either reading the repeat was due by March 2026 and no record is on file.

Recommended action. Record the governing interval in the plan with the rationale, then schedule and execute the repeat OQ. If a repeat exists, upload it and this finding closes.

Major

Reference thermometer used for the OQ has an expired calibration

Affected
Calibration certificate TH-117, page 2; IQ/OQ protocol, test instruments table, page 6
Reference
EU-GMP Chapter 3, section 3.41 (calibration of measuring equipment); Annex 15, section 3

The certificate shows a calibration date but no next-due date, and the only certificate on file expired on 14 May 2026, before the OQ date. The status of the reference on the day of the test cannot be established, so the measurements it produced are not traceable.

Recommended action. Obtain the current certificate or recalibrate, record the due date on the instrument list, and assess the impact on every test that used this reference.

Other

Template placeholder text left in an approved document

Affected
IQ/OQ protocol, section 5.2, page 9
Reference
EU-GMP Chapter 4 (Documentation)

Section 5.2 still reads "[insert equipment ID]". The identity is stated correctly on the cover page, so the file can be tied to the unit, but the residue shows the approval review did not read every page.

Recommended action. Correct in the next revision and record the change under document control.

Other

Cleaning SOP cites a superseded procedure number

Affected
SOP-CL-004 rev 4, section 2 (references)
Reference
EU-GMP Chapter 4 (Documentation)

The reference list points to SOP-EQ-011 rev 2, which was replaced by rev 3 in 2025. The current procedure is in use on the floor; only the cross-reference is stale.

Recommended action. Update the reference at the next revision; no deviation needed.

Open questions

  • Was the OQ repeated in 2026? No record was uploaded. If one exists, upload it and the second finding closes.
  • Which of the two identical units in room 2 does the calibration certificate TH-117 belong to? The serial on the certificate is not on the instrument list.

Outstanding validation activities

  • Performance Qualification for AC-02 is not on file; IQ and OQ exist.
  • Deviation for the blank OQ execution to be opened and closed.

Documents reviewed

  • IQ/OQ protocol, autoclave AC-02 (14 pages, read visually)
  • Calibration certificates 2025 (3 pages, read visually)
  • SOP-CL-004 Cleaning of sterile equipment, rev 4 (text)

Documents not reviewed

These uploaded documents were not part of this review. Nothing in this report applies to them.

  • Qualification binder, room 2 (126 pages): over the 100-page limit for one review. Review it in parts.

Decision-support document. Findings must be reviewed and signed by a qualified person before use. Page 1 of 3.

Illustrative. No customer data; the facility, documents and dates are invented from patterns seen across many qualification files.

What the Inspector checks

The things that get written up.

The knowledge base behind the Inspector was written from executed qualifications that passed inspection and from the review comments that came back on the ones that did not. It reviews your documents against that practice and the public EU-GMP framework, and never invents a requirement.

Qualification completeness

URS, IQ, OQ and PQ present, executed and closed, with the traceability an inspector will follow from the requirement to the result.

Signatures, dates and blank fields

Every closing point signed, every field filled or struck through, no acceptance ticked over an empty measurement column.

Requalification and calibration

Intervals kept, certificates valid on the day, the instrument on the nameplate the same as the instrument in the file.

Deviations and open items

Deviations recorded, assessed and closed, outstanding activities listed rather than quietly dropped.

Data integrity

Raw data present and consistent across sections, serial numbers and dates that agree, no template text left behind.

OEM-locked instruments

Instruments that need the manufacturer's certified qualification are named as such, so nothing is signed off that cannot be.

In the inspector’s language

Critical, major, other.

Findings use the EU-GMP inspection deficiency classes, so the report reads like the one you are preparing for.

Critical

Would on its own put the inspection outcome, product quality or patient safety in question: no qualification for a critical instrument, missing or falsified raw data, unqualified equipment used for release testing.

Major

A serious deviation an inspector will write up and that escalates in combination: expired requalification or calibration, a missing PQ, an obsolete SOP in use, incomplete documentation for a critical step.

Other

A departure from GMP that is neither critical nor major: formatting, a missing cross-reference, a late but performed review signature. Not “minor”, and not ignored.

Pricing

Pay for questions, not seats.

A question to the Inspector costs 1 credit, a Gap Report 5. Plans bring monthly credits; packs never expire. Prices are without VAT.

Trial

Free

15 credits, once

Enough for a real review of a qualification file and a first Gap Report.

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Starter

EUR 149 / month

100 credits a month

For one facility preparing for an inspection.

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Professional

EUR 399 / month

400 credits a month

For a quality team reviewing documentation continuously.

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Need more in a busy month? Credit packs: 50 credits for EUR 29, 200 credits for EUR 99. They never expire.

Questions

Asked before signing up.

Does Gaptria replace our qualified person?
No. It is decision support. Every answer and every Gap Report carries the reminder that findings must be reviewed and signed by a qualified person before use, and the product never issues a readiness score.
Our files are scans of signed paper. Does that work?
Yes. Most qualification files are scans, and the Inspector reads pages visually, stamps, signatures and handwriting included. A review covers up to 100 pages of scans at a time; larger binders are reviewed in parts.
Which frameworks does it review against?
EU-GMP expectations, Annex 15 in particular, plus a knowledge base written from years of executed qualifications. FDA-targeted facilities are reviewed to the same expectations, which are at least as strict for this documentation.
Where do our documents go?
They are stored in Frankfurt and processed for each review by Anthropic's AI service in the United States, under terms that exclude training on your data. You can delete any document, any conversation, or the whole account at any time.

Know before they do.

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