GMP ConsultantNL
Independent GMP Advisory
Diagnostic

GMP Readiness Score

Twenty questions across the seven domains inspectors spend most of their time in. Answer honestly rather than aspirationally — the score is only useful if it tells you something you did not already want to hear. Nothing is submitted or stored; the calculation runs entirely in your browser.

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Readiness0 of 20 answered

Not started

Answer at least two sections to see where your exposure concentrates.

Discuss your score
Scoring keyNo = absent or informal · Part = exists but incomplete · Yes = documented and followed · Ver. = documented, followed, and verified effective

The assessment

Quality management system

1Quality management system

3 questions

  • Is your quality manual current, and does it describe how the site actually operates today?

  • Is management review held on schedule with documented decisions and follow-through?

  • Does an annual product quality review actually drive change, rather than being compiled and filed?

Deviations

2Deviations

3 questions

  • Are deviations raised within one working day of detection, by operators as well as QA?

  • Do investigations reach a confirmed root cause, rather than stopping at "human error"?

  • Do you trend deviations and act on recurrence before an inspector spots the pattern?

CAPA

3CAPA

3 questions

  • Are CAPAs closed within their target date, with overdue items visible to management?

  • Is effectiveness checked against a pre-defined criterion, not just confirmed as "implemented"?

  • Is corrective action distinguished from preventive action in practice, not only in the SOP?

Documentation & data integrity

4Documentation & data integrity

3 questions

  • Are records complete, contemporaneous and attributable, including on paper at the line?

  • Do computerised systems have enabled audit trails that someone actually reviews?

  • Can you retrieve any batch record, training file or calibration certificate within 15 minutes?

Validation & qualification

5Validation & qualification

3 questions

  • Is the validation master plan current and does equipment qualification status match reality?

  • Is cleaning validation supported by current residue limits and a defensible worst-case rationale?

  • Is continued process verification running, with data reviewed rather than merely collected?

Change & supplier control

6Change & supplier control

2 questions

  • Does every change, including temporary and IT changes, pass through change control before implementation?

  • Are suppliers and CMOs qualified on a risk-based schedule, with current quality agreements?

Inspection readiness

7Inspection readiness

3 questions

  • Could you host an unannounced inspection this week without a preparation scramble?

  • Are all commitments from your last inspection or client audit fully closed and evidenced?

  • Have your SMEs been rehearsed on answering only what is asked, with a back room that functions?

After the scoreThe number is the easy part. Sequencing the response is the work.

A score tells you where to look. It does not tell you what to do first.

Send us your section breakdown and we will come back with a view on which two gaps to close first and why, sequenced by regulatory exposure and by what your team can realistically absorb this quarter. That conversation costs nothing.

Now put a number on it
Next step

Send us your breakdown

We will come back with which two gaps to close first, sequenced by exposure and by what your team can realistically absorb this quarter.

Send us your breakdownPut a number on it