GMP Mock Audit
Walk through your site the way an inspector would. Ten audit areas, the evidence an auditor asks for, and a closing report with classified findings, suggested CAPAs and a PDF you can take to your quality team.
How the mock audit works
The audit follows the structure of EU GMP Part I and its annexes, with the matching US 21 CFR Part 211 references, and classifies findings the way GMP inspectorates do.
Scope, like a real audit
You first define the site, product types and authorities. Sterile manufacturing adds an Annex 1 audit area; every other area applies to all sites, and any checkpoint can be marked not applicable.
Classified findings
Each checkpoint carries a criticality. Your answer turns it into a critical, major or minor finding, or an observation, following the logic of PIC/S and EU inspection deficiency classification.
Score and outcome
Checkpoints are weighted by criticality (3, 2, 1) into a GMP Audit Readiness Score out of 100. Any critical finding sets the simulated outcome to “not acceptable”, whatever the score.
This mock audit is an indicative self-assessment for orientation only. It is not a GMP audit, certification or inspection outcome, and it is not regulatory advice. Classifications are simulated from your own answers; an inspector will classify deficiencies on the evidence they see. Always check the current legislation and guidance for each market. Your answers are kept in your browser and are not sent to Molgenium unless you save the report to your profile or choose to contact us.