FDA and Global GMP Audits: What’s Changing for Manufacturers?
- 11/15/2018
- Posted by: Charles.YANG
- Category: Industry Insights
The global pharmaceutical and medical device industries have long adhered to Good Manufacturing Practices (GMP). But recent shifts in how the U.S. FDA conducts international inspections have raised the bar—especially for Asian manufacturers exporting to Europe or North America.
At Eddso, we’ve seen a growing number of clients struggle with regulatory compliance not because their products are bad, but because their documentation, traceability, and audit readiness fall short of evolving expectations.
The FDA’s New Expectations
Historically, overseas FDA audits focused on basic hygiene, traceability, and contamination risks. Today, the lens has shifted to:
- Data integrity and digital records
- Risk-based validation of critical processes
- Supplier management & outsourced sterilization control
- Environmental monitoring in cleanroom zones
- Electronic batch records (EBR) and audit trail systems
Field Practice: A Real Case
Last year, our team worked with a sterile packaging factory in East China. Though the plant had passed a CE audit for European export, it failed a U.S. FDA inspection due to:
- Missing audit trail on labeling software
- Uncalibrated particle monitoring sensors in cleanroom
- No formal training records for shift supervisors
None of these were related to product quality—but all were compliance killers.
These aren’t just best practices—they’re becoming expectations, especially in post-COVID scenarios.
Eddso’s Quality Interim Approach
With our QR2: Process Quality Validation service, we support GMP-regulated facilities in preparing for:
- FDA mock inspections and gap analysis
- Document system reviews (SOPs, calibration logs, deviation records)
- Validation traceability mapping (process, cleaning, transport)
- Training record structure & audit readiness workshops
- CAPA coaching: not just corrective—but preventive and systematic
All reports are compiled in an English audit file, following ICH Q10 principles and aligned with FDA CFR 21 Part 11 where applicable.
Key Advice for Global Suppliers
- Don’t treat the FDA like just another audit. It’s not ISO—it’s regulatory.
- Digital compliance matters more than ever. Excel logs won’t cut it anymore.
- Train your people, not just your QA lead. Auditors often talk to operators first.
Eddso’s Vision
We’re not just helping clients pass inspections—we’re building long-term GMP capability that survives personnel turnover, audit cycles, and rising international scrutiny.
Compliance is not a certificate. It’s a culture.