# GMP Inspection Readiness Self-Assessment for Pharma Plants > Source: https://netray.co/tools/pharma-gmp-inspection-readiness-assessment > Publisher: Netray (netray.co), AI and integration engineering for ERP and manufacturing systems. > Section: Free Tools ## Short answer Score how ready your site is for a regulatory GMP inspection and see where to focus first. ## Category compliance-legal ## Industry Pharma and Life Sciences ## Audience - Quality head - Plant manager - Regulatory affairs ## Tool **Kind:** assessment **Questions:** #### How do you handle deviations and investigations? **Help:** Think about timeliness, root cause quality and recurring issues. **Options:** ##### Many open past due, root cause often 'human error' **Score:** 0 ##### Mostly on time, root cause quality varies **Score:** 2 ##### On time, structured root cause, trended for repeats **Score:** 4 #### How effective is your CAPA system? **Options:** ##### Actions close without effectiveness checks **Score:** 0 ##### Effectiveness checks exist but are inconsistent **Score:** 2 ##### Effectiveness verified and linked to trend data **Score:** 4 #### How mature is your data integrity programme? **Options:** ##### No formal programme or audit trail review **Score:** 0 ##### Policy and training in place, review is patchy **Score:** 2 ##### Routine audit trail review, role separation, periodic audits **Score:** 4 #### How current are your SOPs and batch records? **Options:** ##### Several overdue for review or contradict practice **Score:** 0 ##### Mostly current, some gaps between SOP and practice **Score:** 2 ##### Reviewed on schedule, verified against practice **Score:** 4 #### How do you manage change control? **Options:** ##### Changes sometimes made before approval **Score:** 0 ##### Approved first, impact assessment is uneven **Score:** 2 ##### Risk based impact assessment, validation and regulatory impact checked **Score:** 4 #### How current is equipment qualification and calibration? **Options:** ##### Overdue calibrations or unqualified equipment in use **Score:** 0 ##### Mostly current, occasional lapses **Score:** 2 ##### Fully current, with periodic review and tracked out-of-tolerance impact **Score:** 4 #### How well is your workforce trained for GMP? **Options:** ##### Training records incomplete or generic **Score:** 0 ##### Role based training, effectiveness rarely checked **Score:** 2 ##### Role based, assessed, and tied to system access **Score:** 4 #### How do you control suppliers and contract labs? **Options:** ##### Little qualification or auditing **Score:** 0 ##### Qualified, quality agreements partly outdated **Score:** 2 ##### Risk based qualification, audits and current quality agreements **Score:** 4 #### How prepared is your inspection team and document retrieval? **Options:** ##### No defined roles or practice **Score:** 0 ##### Roles defined, little rehearsal **Score:** 2 ##### Front room, back room and scribe roles rehearsed, documents retrievable quickly **Score:** 4 #### How do you review environmental and utility monitoring trends? **Options:** ##### Results reviewed only when a limit is exceeded **Score:** 0 ##### Periodic trend reports with limited follow-up **Score:** 2 ##### Routine trending with alert levels and documented actions **Score:** 4 **Bands:** #### High exposure **Min:** 0 **Max:** 39 **Verdict:** Your site would likely receive significant observations in a regulatory inspection. **Recommendations:** - Start with a gap assessment of deviations, CAPA and data integrity. - Clear overdue deviations and calibrations before anything else. - Run a mock inspection with an independent auditor. #### Developing **Min:** 40 **Max:** 64 **Verdict:** The basics exist, but gaps in consistency would be visible to an inspector. **Recommendations:** - Close the gap between SOPs and daily practice with floor walk-throughs. - Add effectiveness checks to CAPA and trend deviations by cause. - Rehearse document retrieval and the inspection team roles. #### Mostly ready **Min:** 65 **Max:** 84 **Verdict:** Your quality system is sound with a few areas to tighten. **Recommendations:** - Target the lowest scoring areas with a focused mock audit. - Review audit trail evidence and supplier quality agreements. - Keep trending and management review active between inspections. #### Inspection ready **Min:** 85 **Max:** 100 **Verdict:** Your answers describe a mature, evidence based quality system. **Recommendations:** - Keep rehearsing and refreshing the inspection team. - Test the system with unannounced internal audits. - Share lessons across sites and update the quality plan yearly. ## Content **Intro:** Regulators judge a site on how its quality system behaves day to day, not only on documents. This self-assessment asks 10 questions about the areas inspectors most often probe and gives you a score with a short action list. **Sections:** #### How to use the assessment **Body:** Answer for the site as it actually operates today, ideally together with the heads of QA, QC and production so that optimistic answers get challenged. Each answer scores 0, 2 or 4 points, and the result converts to a percentage. Export the result and the recommendations to share with leadership, then repeat the assessment after a mock inspection to see what moved. #### Why these topics **Body:** Deviations, CAPA, data integrity, change control, equipment, training and suppliers appear again and again in warning letters and inspection reports. They also link to each other: a weak deviation process produces weak CAPA, and weak CAPA allows repeat events. Environmental and utility trending is included because it shows whether the site notices drift before it becomes a failure. #### Reading the score **Body:** The bands are a guide, not a rating from any regulator. A site with a high score and one serious data integrity gap is still at risk, so look at individual answers as well as the total. Any question where you chose the lowest option deserves a named owner and a date, whatever your overall score. **Bullets:** - Use the lowest scoring answers to set the mock audit scope. - Check that the same issues are not already in open CAPAs. - Reassess after major changes such as a new line or system. #### Common mistakes **Body:** Readiness drives are often a burst of document cleanup right before a visit. Inspectors notice when records have been rewritten, and the real exposure is in behaviour on the floor. Prepare people to answer questions honestly and consistently, and make sure the team can show the evidence for any statement made in an opening presentation. **Cta:** If you want evidence rather than self-reported answers, Netray can help build a private on-prem dashboard over your ERP, QMS and LIMS data showing overdue deviations, calibrations and training in one place. **Faq:** #### Is this an official regulator score? **Answer:** No. It is a self-assessment tool built from common inspection themes. It does not predict the outcome of an FDA, EMA, MHRA or other inspection, but it helps you find weak spots before an inspector does. #### How long does the assessment take? **Answer:** About 10 minutes if the right people are in the room. The value comes from the discussion about each answer and the evidence behind it, so allow extra time to agree on owners and dates for the gaps you find. #### Should we run a mock inspection as well? **Answer:** Yes, if the score is below the top band. A mock inspection by an independent auditor tests how staff respond, how fast records are retrieved and whether practice matches procedures, which a questionnaire cannot show. #### Does it apply to medical device or API plants? **Answer:** The themes apply, but regulations differ, for example 21 CFR 820 or ISO 13485 for devices and ICH Q7 for APIs. Treat the questions as a starting point and add checks specific to your regulations and products. ## Search terms gmp inspection readiness, fda inspection preparation checklist, mock inspection pharma, gmp self assessment, regulatory inspection readiness score, inspection backroom front room, pharma quality system maturity --- Talk to an engineer: https://netray.co/contact?intent=erp_ai | Machine catalog: https://netray.co/agent/catalog.json