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GxP Audits Accepted by Regulators, QPs and Product Holders Worldwide
GCP, GPvP, GLP and ISO 13485 medical device audits, conducted by qualified subject matter experts across our global supplier network, beyond the scope of a standard GMP audit.
Beyond GMP A Full GxP Audit Programme for Every Supplier Type
Pharma Compliance RX conducts other GxP audits (GCP, GDP, GLP, GPvP and more) for suppliers across the globe, in addition to standard GmP audits. Each GxP audit type covers a distinct part of the product lifecycle, from clinical data integrity to pharmacovigilance systems to non-clinical laboratory practice, and each is handled by auditors qualified specifically for that audit type. These GxP audits are conducted by highly qualified auditors and subject matter experts, applying the relevant national and international standards as needed by each customer. Audit reports produced through this GxP audit programme are detailed, fully acceptable, and valid amongst regulators, Qualified Persons (QPs) and other product holders across the globe.
What We Help GxP Audit Coverage Across Your Supplier Base
From clinical sites to pharmacovigilance systems to medical device manufacturers, our GxP audit scope extends wherever your supply chain needs it.
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GCP Audit
Good Clinical Practice audits of clinical trial sites, sponsors, CROs and investigator sites, verifying data integrity, subject safety and protocol compliance against applicable GCP standards.
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GPvP Audit
Good Pharmacovigilance Practice audits of drug safety systems, adverse event reporting, signal management and PSMF documentation, benchmarked against the relevant regulatory GPvP framework.
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GLP Audit
Good Laboratory Practice audits of non-clinical testing facilities, covering study conduct, data traceability, equipment qualification and quality assurance oversight.
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Medical Device Audit (ISO 13485)
Medical device supplier audits conducted as per ISO 13485, assessing the quality management system, design controls and manufacturing practices of device manufacturers worldwide.
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Auditor Selection From Our Qualified Pool
Every client selects the best-fit auditor from our qualified auditor pool for their specific GxP audit type, industry and region, rather than being assigned one by default.
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Report Review Before Finalization
Every client reviews the audit report and submits comments before it is finalized, so the final report matches internal quality and documentation needs.
How a GxP Audit Runs From Scoping to Final Report
Every GCP, GPvP, GLP or medical device audit follows the same disciplined path, adapted to the standard that applies to your supplier.
01
Audit Type & Standard Confirmation
Confirming whether the supplier needs a GCP, GPvP, GLP or ISO 13485 medical device audit, and which national or international standard applies.
02
Auditor Matching From the Qualified Pool
Matching the audit to a subject matter expert auditor qualified for that specific GxP audit type, then giving the client the final say on auditor selection.
03
On-Site or Remote Audit Conduct
Conducting the audit against the confirmed standard, covering documentation, systems, personnel and facilities relevant to the audit type.
04
Detailed Audit Report Drafting
Drafting a detailed audit report structured to be fully acceptable and valid to regulators, QPs and other product holders reviewing the supplier.
05
Client Review & Comment
Sharing the draft report with the client for review, so any comments can be raised before the report is finalized.
06
Report Finalization & Distribution
Finalizing the GxP audit report to incorporate client feedback, ready for submission to regulators, QPs or downstream product holders.
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