Conducting GMP Auditing Services Worldwide

Depending on customer request, our quality auditing service runs from initiating the audit with the supplier through to delivering the complete audit report, covering pre-audit preparation, arrangements, conducting, reporting, CAPA and closure.

Pre-Audit Preparation Audit Conducting CAPA & Follow-Up Audit Closure
Auditor RelationshipFully Independent
Report FormatClient & Regulator Ready
Programme OptionsSingle / Recurring
Consultant Experience12–35 yrs

Quality GMP Auditing Services A Complete Service, Start to Finish

Depending upon the customer's request, our quality auditing service can start from initiating the audit with the supplier up to providing the complete audit report to the client. Every stage below can be delivered as a standalone step or as part of one continuous engagement, so clients only pay for the part of the lifecycle they need.

What's Included EveryStage of the Audit Lifecycle, Available on Request

Clients can engage us for a single stage or the full lifecycle below, depending on what the audit requires.

QAS / 01
Pre-Audit Preparation

Scope confirmation, document requests and background review before any auditor is deployed to site.

QAS / 02
Audit Arrangements

Scheduled re-audits on a cadence that matches your risk model.

QAS / 03
Audit Conducting

On-site or remote assessment carried out against the agreed regulatory standard.

QAS / 04
Audit Summary & Final Report

A summary report issued promptly after close-out, followed by a detailed final report documenting every finding.

QAS / 05
CAPA Including Follow-Up

Corrective and preventive actions tracked from the report through to verified resolution.

QAS / 06
Audit Closure & Re-Audit

Formal closure of the audit, with a follow-up audit scheduled every three years or sooner where risk requires.

How The Audit Runs From Initiating Contact With the Supplier to the Final Report

Every engagement follows the same sequence, whether the client requests one stage or the complete service.

01

Pre-Audit Preparation

Confirming audit scope, standard and documentation requirements before initiating contact with the supplier.

02

Audit Arrangements Including Travel and Bookings

Coordinating travel planning and bookings directly with the supplier site ahead of the audit date.

03

Audit Conducting

Carrying out the on-site or remote assessment against the confirmed regulatory standard.

04

Audit Summary Report

Issuing a summary report promptly after close-out, giving the client an early view of findings.

05

Audit Final Report

Delivering the complete, detailed final report the client can act on and share with regulators or QPs.

06

CAPA, Closure & Follow-Up Audit Every 3 Years

Tracking CAPA to resolution, formally closing the audit, and scheduling the follow-up audit on a three-year cycle.

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One accountable partner across audits, filings and quality systems — staffed from the same specialist panel.

Need Only Part of the Audit Lifecycle Handled?

Tell us where you want the engagement to start, whether that is pre-audit preparation or the full lifecycle through to CAPA closure, and we will scope it accordingly.

Frequently Asked Questions

Does Pharma Compliance RX handle the entire audit process?

Yes. Depending upon customer request, Pharma Compliance RX can start from initiating the audit with the supplier and carry the engagement through to delivering the complete audit report.

Pre-audit preparation covers scope confirmation, document requests and background review before an auditor is deployed to the supplier site.

Yes. Audit arrangements, including travel and bookings, are coordinated directly with the supplier ahead of the audit date.

The audit summary report is issued promptly after close-out, and the audit final report follows as the complete, detailed document covering every finding.

A follow-up audit is scheduled every three years as part of the standard audit closure and requalification cycle.