At GMPharma, we deliver hands-on, results-driven GMP compliance solutions. Here are a few examples of how we've helped clients meet regulatory expectations and strengthen their quality systems.

🧪 Case Study 1: GMP Audit Recovery – Biotech Manufacturer

Challenge: The client received 27 deficiencies from a TGA inspection, including several major non-conformances related to cleanroom qualification and documentation.

Solution: We performed a rapid gap analysis, prioritized CAPAs, and implemented a revised QMS structure in under 3 months.

Result: Passed re-inspection with no critical findings. Client maintained product release schedule and regulatory standing.

💊 Case Study 2: CAPA System Overhaul – Contract Manufacturing Organisation

Challenge: Repeated audit observations indicated a weak investigation and CAPA system.

Solution: Redesigned the CAPA process, trained staff across departments, and embedded root cause analysis tools into the workflow.

Result: Improved investigation closure times by 45% and achieved zero CAPA-related findings in the next audit.

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🚀 Case Study 3: Greenfield GMP Facility Setup – Start-up Pharma Company

Challenge: A new client needed to set up a GMP-compliant Grade B and Grade C cleanroom suite for injectable manufacturing.

Solution: Designed and implemented cleanrooms, developed QMS from scratch, and trained staff to pass the first inspection.

Result: Passed TGA inspection with no major findings; operations commenced on schedule.