GMP Audit Checklist And Compliance Readiness Survey

Thanks for taking this GMP audit readiness check. Your responses are completely confidential and anonymized. It covers documentation, training, equipment, suppliers, and corrective actions, plus a few follow-up questions about your most recent findings. About 6-8 minutes.

What type of audit or assessment does this response relate to?

• Internal self-audit
• Corporate/parent-company audit
• Supplier or vendor audit
• Regulatory agency inspection
• Third-party certification audit
• Other

Based on your most recent audit or your day-to-day observation, how would you rate compliance in each area?

In the last 12 months, has this site received a major or critical audit finding?

• Yes
• No
• Unsure

Which of these areas currently poses the greatest risk to product quality if left unaddressed?

• Documentation and record-keeping
• Personnel training and hygiene practices
• Equipment calibration and maintenance
• Material and supplier qualification
• Process and cleaning validation
• Deviation and CAPA management
• Facility and environmental controls
• Data integrity and system access controls

If a regulatory inspector arrived unannounced today, how confident are you that this site would pass without a major finding?

Describe the most significant nonconformance identified in the most recent audit, including its current corrective action status.

Probe the root cause behind the respondent's most significant nonconformance or highest-risk area: was it a one-off human error, a process design gap, a resourcing/staffing issue, or a systemic failure across the site? Ask what the corrective action actually changed versus what was documented on paper, whether similar deviations have recurred before, and whether the fix addressed the root cause or just the symptom. If they report no major findings, probe what near-misses or informal workarounds staff use that wouldn't show up in a formal audit.

How would you rate site leadership's visible day-to-day commitment to quality, beyond what's written in the quality manual?

On average, how long does it take to close a corrective and preventive action (CAPA) at this site?

• Under 30 days
• 30-60 days
• 61-90 days
• Over 90 days
• We don't formally track this

Is there anything else auditors should know before the next audit?

What is your role at this site?

• Quality Assurance
• Quality Control
• Production/Operations
• Regulatory Affairs
• Site Leadership
• External Auditor/Consultant
• Other
• Prefer not to say

How many years have you worked in GMP-regulated roles?

• Less than 1 year
• 1-3 years
• 4-7 years
• 8-15 years
• More than 15 years
• Prefer not to say

Thank you — your responses feed directly into the site's audit readiness report and help prioritize which corrective actions to tackle before the next inspection.