- 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 of different types of suppliers across the globe, applying the regulatory standard the client needs, whether that is EU GMP, ICH Q7, 21 CFR 210/211, ISO or another applicable framework. Where a standard audit does not fit, we also perform tailor-made and customized audits built around a specific focused area, a specific standard, a specific product or system, audit criticality, or a for-cause investigation. Every audit report we issue is detailed and top quality, which is why it is well accepted globally by regulators, QPs and subject matter experts reviewing your supply chain.
Supplier Types We Audit Across Your Global Supply Chain
Our GMP audit programme is not limited to one supplier category. Here is where we work most often.
GMP / 01 API
Intermediates & Biological Products
Sterile and non-sterile API, API intermediate and biological or fermentation-based product manufacturers.
GMP / 02
Formulated Medicinal Products
Sterile and non-sterile finished dosage form manufacturers.
GMP / 03
Packaging Material Suppliers
Primary and secondary packaging material manufacturers supplying regulated product.
GMP / 04
Excipients, KSMs, Raw Materials & Cosmetics
Excipients, Key Starting Materials, raw materials and cosmetics suppliers.
GMP / 05
Testing Laboratories
Contract and in-house testing laboratories supporting release and stability testing.
GMP / 06
Distributor GDP & Processing Sites
Distributors audited against GDP requirements, plus processing sites such as micronization, sterilization and radiation facilities.
The Complete Audit LifecycleQuality GMP Auditing Services
From scoping the first request to closing the final report, here is how a GMP audit runs with us.
01
Scope & Standard Confirmation
Confirming the supplier type, the applicable standard (EU GMP, ICH Q7, 21 CFR 210/211, ISO) and whether a tailor-made or for-cause scope is needed.
02
Auditor Matching & SchedulingConfirmation
Matching the audit to a qualified auditor for that supplier category and standard, then handling scheduling and arrangements end to end.
03
On-Site or Remote Audit Conduct
Conducting the audit against the confirmed standard, with a summary issued promptly after close-out.
04
Detailed Final Report Drafting
Drafting a detailed, top-quality report accepted by regulators, QPs and subject matter experts, documenting every finding and its classification.
05
CAPA Management & Follow-Up
Tracking corrective actions raised in the report through to resolution, rather than leaving them open once the report ships.
06
Audit Closure & Re-Audit Planning
Formal closure of the audit, with a follow-up audit scheduled on a recurring cycle or sooner where risk requires it.
Explore our other services
One accountable partner across audits, filings and quality systems — staffed from the same specialist panel.