Free GMP Self-Assessment: Score Your Quality System

How healthy is your quality system? Fifteen questions, about six minutes. Each one is a provision of 21 CFR 211 that the FDA cited more than once in July 2026, and together they account for 55 of that month’s 75 observations. These are conditions inspectors actually verified: not what your SOPs say, but what your system does. Answer honestly; the score is for you.

You will see your score immediately, with the patterns behind the month’s findings, and you can download the full deficiency analysis of all 62 inspections classified that month.

GMP Compliance Self-Assessment

Fifteen questions, one for each regulation the FDA cited more than once in July 2026. Those fifteen provisions of 21 CFR 211 account for 55 of the month's 75 observations. Answer honestly. The score is for you, and nobody sees your answers unless you choose to share them. When you finish you can download the full analysis of all 62 inspections classified that month.

Page 1 of 15

How many of your quality unit's own procedures, release, deviations, change control and annual product review, are past their review date right now? I know the number, it is small, and it is shrinking Some, we catch up in bursts when an audit approaches I do not know the number and I would rather not look

Page 2 of 15

When an operator finishes a production step, when does it get written into the batch record? At the step, and our in-process checks would catch it if it were not Usually at the step, sometimes at the end of the shift End of shift or end of run is normal here We have found steps written up afterwards and have not closed it out

Page 3 of 15

Take the product you transferred in or changed most recently. Is there an approved master production and control record covering every step of it? Yes, approved before the first batch ran Approved, but after the first batch had already run Some steps sit in worksheets or operator knowledge rather than the master record I would have to check

Page 4 of 15

Of your last ten closed deviations, how many ended with "human error" or "operator retrained"? Two or fewer, we usually reach a true system cause Around half, it is a common outcome here Most of them, retraining is our default corrective action

Page 5 of 15

Pick a CAPA you closed last year. Could you show evidence today that it actually worked? Yes, effectiveness checks have defined criteria and real data behind them Partly, checks exist but often just say no recurrence observed Closing the action is our closure, we rarely go back to verify

Page 6 of 15

Your release specification for your main product: who decided the acceptance criteria, and could you show why? There is a written, retrievable justification for the limits It is approved and signed, but the reasoning is not written down It came from the method or the pharmacopoeia and we have not documented our own rationale It is inherited, and nobody currently at the site chose it

Page 7 of 15

Shared equipment and multiproduct areas: what is actually behind your cleaning? A written procedure with acceptance criteria and current validation data Cleaning validation exists but has not been revisited in years Written SOPs and operator care, never formally validated Some equipment is cleaned to experience rather than a written method

Page 8 of 15

How do you know your GMP training actually worked? Competence is verified in practice, through observation or assessment Signed read-and-understand records are our main evidence Training records get completed in a rush before audits

Page 9 of 15

For your non-sterile products, what actually stops microbiological contamination? Written procedures specific to the product, and we can show they are followed We have procedures, but could not readily show they are followed Facility design and general hygiene practice, rather than a written procedure

Page 10 of 15

Is there a piece of equipment at your site that is genuinely hard to clean properly? Yes, and the difficulty is documented with a rationale or a design change Yes, and we manage it with extra effort rather than a documented assessment Probably, but we have never assessed design against the cleaning we claim for it No, we have never looked at it that way

Page 11 of 15

Could you produce the cleaning record for one specific piece of equipment on one specific date last month? Yes, within minutes, showing the method and who did it Yes for major cleans, not for routine ones It would take some looking No

Page 12 of 15

Who reviews the audit trails on your lab and production systems, and when? Defined risk-based review, release-relevant trails are checked before release There is a policy, but reviews happen irregularly and evidence is thin Honestly, nobody reviews them systematically

Page 13 of 15

An instrument that generates GMP data goes past its calibration due date. What happens? It cannot be used, the control prevents it It gets picked up at the next scheduled check It would be found later and handled as a deviation We would probably not notice

Page 14 of 15

Your stability programme: has a pull point been missed in the last two years? No, and adherence is tracked Yes, and the impact on expiry dating was assessed and recorded Yes, and it was not formally assessed I do not know, adherence is not tracked

Page 15 of 15

You rely on a supplier's certificate of analysis. How did you establish that the certificate is reliable? Full testing at qualification, and re-established at intervals since Full testing at qualification, never repeated For critical materials only We have their certificates and a questionnaire on file

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Built by Gregory Sivo, GMP consultant. The questions come from what the FDA cited last month, not from a generic checklist.