Pharmaceutical GMP Compliance Auditing

Service summary

A non-regulatory assessment of pharmaceutical manufacturing activities against selected GMP requirements. The audit examines quality systems, operational controls and evidence supporting consistent execution of the activities within scope.

The service supports supplier qualification or independent oversight. It does not issue a regulator’s GMP certificate, manufacturing authorisation or product approval, and the applicable technical competence must be confirmed before engagement.

Key objectives

• Assess selected pharmaceutical GMP requirements
• Examine manufacturing and documentation controls
• Evaluate contamination and deviation management
• Identify significant quality-system evidence gaps

Methodology

Qualified auditors use the agreed GMP framework to examine selected products, processes and records without presenting the engagement as an official inspection.

• Define products, dosage forms, activities, GMP criteria and competence needs.
• Review quality documentation, facility information and significant prior issues.
• Select manufacturing processes, batches and quality events.
• Observe relevant premises, practices and contamination controls.
• Trace production, validation, laboratory and release-related records within scope.
• Evaluate deviations, changes and corrective action effectiveness.
• Report GMP findings and explicitly state the non-regulatory status.

Key outcomes

References: [G04] · [G14]

• Independent GMP audit report
• Process and documentation findings
• Quality-event assessment
• Supplier qualification evidence