Ten-question GMP self-check
Answer honestly for your own site. It takes about five minutes. Your answers stay in your browser: nothing is sent or stored.
Are your records complete, and is every decision written down?
EU GMP 4.8Empty fields, a report without a pass or fail decision, an entry not made at the time of the activity.
Read: EU GMP 4.8
Does your APS reflect the interventions and worst cases of real production?
EU GMP Annex 1 §9.34, §9.44 · aseptic manufacturingInterventions that vary from run to run, worst-case conditions left out, incubation conditions not justified.
Read: Annex 1 §9.32–9.38, §9.44
Does each SOP take effect only after approval, and are the people who use it trained on it?
EU GMP 4.3, 2.11An effective date before the approval date, a new version in force with no training record.
Read: EU GMP 4.3, 2.11
Does the qualified state of your equipment match what is in use today?
EU GMP Annex 15Calibration certificates missing, pressure differentials far from the qualification values, retired equipment still named in SOPs.
Read: Annex 15 §4.1–4.2, EU GMP 3.41
Is monitoring data recorded so that trends can be evaluated, and are critical alarms active?
EU GMP 6.9; Annex 1 §4.16 for critical pressure differentialsWarning for a critical pressure differential not active, ventilation data not stored, manual readings never reviewed for trends.
Read: Annex 1 §4.16, EU GMP 6.9
Do the GMP activities that need a written procedure have one?
EU GMP 4.29Typical gaps: IT access rights, entry requirements for clean areas, complaints.
Read: EU GMP 4.29
Does your training plan match each person's actual tasks?
EU GMP 2.11Training done but not linked to the job description, effectiveness never assessed.
Read: EU GMP 2.11
Does your self-inspection plan cover every GMP area, and is it followed?
EU GMP Chapter 9Areas missing from the plan, audits postponed without a recorded reason.
Read: EU GMP 9.1–9.3
Does every change reach all the documents it affects?
EU GMP Chapter 1, ICH Q10The SOP was updated; the form, the specification and the training record were not.
Read: EU GMP 1.4 (xii)–(xiii), Annex 15 §11, ICH Q10 §3.2.3
Are CAPAs completed on time and checked for effectiveness?
ICH Q10 §3.2.2Overdue actions, effectiveness checks pointed to a process that does not perform them.
Read: ICH Q10 §3.2.2, EU GMP 1.4 (xiv)
Answer the questions to see your result
0 of 10 answered.
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This summary is not a score. One open point on a critical topic outweighs nine answered Yes.
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This is a self-assessment against common inspection themes, not an audit and not a statement of compliance. The references point to EU GMP (EudraLex Volume 4) and ICH Q10.