- Home
- / GMP Audit
Independent Audit Reports You Can Rely On
We conduct high-standard GMP audits worldwide across diverse suppliers in accordance with EU GMP, ICH Q7, 21 CFR 210/211, ISO and other applicable standards.
Our Approach Conducting GMP Auditing Services Worldwide
We conduct high-standard GMP audits worldwide across diverse suppliers in accordance with EU GMP, ICH Q7, 21 CFR 210/211, ISO and other applicable standards. Audits can be fully tailor-made to meet specific customer requirements, including focused areas, products, systems, criticality or for-cause investigations. Our detailed audit reports are widely accepted by regulators, Qualified Persons (QPs) and subject matter experts globally, giving your quality and procurement teams a document they can act on immediately.
Beyond GMPOther GxP Audits
We provide comprehensive GxP auditing services worldwide, including GCP, GDP, GLP, GPvP and Medical Device audits, according to relevant national and international requirements.
GxP / 01
GCP Audits
Good Clinical Practice audits across trial sites, sponsors and CROs.
GxP / 02
GDP Audits
Good Distribution Practice audits covering storage, transport and distribution.
GxP / 03
GLP Audits
Good Laboratory Practice audits for non-clinical testing facilities.
GxP / 04
GPvP Audits
Good Pharmacovigilance Practice audits of safety and reporting systems.
GxP / 05
Medical Device Audits
Conducted in accordance with ISO 13485 requirements.
GxP / 06
For-Cause & Tailored Audits
Focused audits scoped to a specific product, system or investigation.
Quality GMP Auditing Services The complete audit lifecycle, start to finish
We work as an integral part of your organization to deliver reports your quality and regulatory teams can act on immediately.
Pre-Audit Preparation
Scope confirmation, document request and review before any consultant is deployed.
Arrangements & Bookings
Audit arrangements, travel planning and bookings handled end to end.
Audit Conducting & Summary Reporting
On-site or remote assessment against GMP, with a summary issued promptly after close-out.
Detailed Audit Final Report
A complete, regulator-acceptable report documenting every finding and its classification.
CAPA Management & Follow-Up
Corrective actions tracked through to resolution, not left open after the report ships.
Audit Closure & Re-Audit
Formal closure, with a follow-up audit scheduled every three years or sooner if risk requires.
Explore our other services
One accountable partner across audits, filings and quality systems — staffed from the same specialist panel.