Good Manufacturing Practice (GMP) Auditing

Protecting Product Quality Through Rigorous GMP Audits

Good Manufacturing Practice compliance is the foundation of pharmaceutical product safety and quality. GxP Global Quality Network provides thorough, systematic GMP audits that go beyond checklist compliance, Network auditors deliver actionable intelligence that strengthens your manufacturing operations and reduces regulatory risk.

Led by Monica Brooks, MSc, engagements draw on over two decades of pharmaceutical industry experience, covering finished dose form manufacturers, API producers, contract manufacturers (CMOs/CDMOs), and raw material suppliers.

GMP Audit Services

• Supplier and vendor qualification audits (routine, for-cause, pre-qualification)
• Internal GMP compliance audits and self-inspection programs
• Contract manufacturing organization (CMO/CDMO) audits
• API manufacturer audits per ICH Q7 and 21 CFR Part 210/211
• Pre-approval inspection (PAI) readiness assessments
• For-cause audits following deviations, OOS results, or regulatory concerns
• EU GMP Annex audit support for international operations
• System-based audits across all pharmaceutical quality systems

Key Focus Areas

• Facilities, equipment, and utilities (qualification/validation status)
• Laboratory controls and out-of-specification (OOS) investigations
• Production and process controls, batch record review
• Materials management: receipt, testing, storage, and disposition
• Packaging and labeling controls
• CAPA systems, change control, and deviation management
• Data integrity and 21 CFR Part 11 compliance
• Stability programs and expiry dating compliance

Audit Deliverables

Every GMP audit engagement concludes with a comprehensive written audit report including: executive summary, detailed observations categorized by risk (Critical/Major/Minor), regulatory references, root cause analysis, and a recommended CAPA action plan, all delivered within agreed timelines.

We also provide follow-up support for CAPA implementation tracking, re-audits, and regulatory response preparation as needed.

Quality standard: All GxP Global Quality Network engagements are led by senior-credentialed auditors with 20+ years of active GxP audit experience, regulatory currency across FDA, EMA, MHRA, and Health Canada standards, and direct accountability for every deliverable.