GMP ConsultantNL
Independent GMP Advisory
GMP Health Index

How strong is your GMP system?

A structured indication of quality-system health across seven domains, mapped to a five-level maturity framework. It names the areas carrying most of your exposure and what to do about each — and it takes about ten minutes.

Before you start

Answer honestly rather than aspirationally. A score is only useful if it tells you something you did not already want to hear. Nothing is transmitted — the calculation and any saved history stay in this browser.

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Overall GMP health0 of 20 answered

Not started

Answer at least two sections to see where exposure concentrates.

Assessment not started.

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

Score the seven domains

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?

If this scores low. Apply one test: could a competent new QA officer follow the system in month one without asking a colleague?

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?

If this scores low. Review the last twenty investigations for confirmed root cause and for impact assessed beyond the batch.

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?

If this scores low. Count how many closed CAPAs had a measurable effectiveness criterion defined before implementation.

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?

If this scores low. Complete the system inventory first — the systems missing from the list are where the gaps are.

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?

If this scores low. Reconcile the validation master plan against the floor, equipment by equipment.

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?

If this scores low. Report how many suppliers are qualified today against current agreements, rather than how many ever were.

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?

If this scores low. Run one timed retrieval exercise. It predicts the first day of an inspection better than any document review.

Assessment historyStored in this browser only. Nothing is transmitted, and clearing it removes it permanently.

Trend over time

No snapshots saved yet. Complete the domains above and choose Save snapshot to start a trend. History is kept in this browser on this device — it will not appear on another machine, and we never receive it.

CoverageNamed rather than implied.

What the index measures, and what it does not yet

Measured today
  • Quality management system
  • Deviations
  • CAPA
  • Documentation & data integrity
  • Validation & qualification
  • Change & supplier control
  • Inspection readiness
Planned, as further assessments are added
  • Qualification
  • Audit readiness
  • Training
  • Complaints
  • OOS / OOT
  • Batch release
  • Computerised systems
  • Quality risk management

These will contribute once the corresponding assessments exist. They are not silently folded into the current score.

How the levels workA GMPConsultant.nl framework, not an official regulatory classification.

Five maturity levels

  1. Level 1

    Reactive

    The process runs when something forces it to.

  2. Level 2

    Controlled

    Procedures exist and are followed, mostly.

  3. Level 3

    Systematic

    The process is designed, resourced and measured.

  4. Level 4

    Integrated

    It connects to the rest of the quality system.

  5. Level 5

    Optimized

    It improves itself, and the improvement holds.

Explore the maturity models
Limits

What the Health Index is, and is not

The GMP Health Index is an educational, decision-support indicator calculated from information you provide. It is not an audit, not an inspection, not a certification and not a regulatory determination, and a score does not demonstrate GMP compliance. It runs entirely in your browser: answers and history are stored locally on this device and are never transmitted to us.

Next step

A score tells you where to look, not what to do first

Sequencing the response by exposure and by what your team can absorb this quarter is the actual work. Send us the domain breakdown and we will come back with a view — that conversation costs nothing.

Discuss your resultExplore the maturity models