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Supplier qualification audits

Outsource your supplier qualification audits to PCS. We audit suppliers against the GxP’s worldwide, with highly experienced GxP auditors.

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Over 550 audits performed worldwide!

Why you should outsource your audits to PCS!

We audit pharma suppliers worldwide,
Over 550 supplier audits performed,
We usually respond within the hour,
We can audit against the GMP, GDP, GLP and GCP guidelines.

GxP Supplier Audits

We perform detailed GxP audits of your third party suppliers. We find current and future problems, helping you identify potential risks in your supply chain.

Clients ask us to qualify suppliers and contractors in the pharmaceutical industry and biotech industry. Our auditing services are worldwide and cover every major regulatory framework.

Julian Koster, Business Development

Curious to see how we can help you with your supplier audits? Plan a meeting today!

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Suppliers we can audit

CMO's (contract manufacturing organizations)
API and excipient suppliers
Distribution and warehousing organizations
Service providers
Contract laboratories

Recent supplier audits completed

Supplier audits in the European Union for Forte Biosciences (USA)

Supplier audits in the European Union for Forte Biosciences (USA)

PCS performed supplier audits for Forte. Including; biotech, medical device and pharmaceutical suppliers in the European Union.

Audits of antivenom suppliers for the Dutch Ministry of Health

PCS performed a number of audits against the EU GMP at suppliers of antivenom and vaccines for the Dutch Ministry of Health.

Audits of antivenom suppliers for the Dutch Ministry of Health

Why choose PCS' consultancy services?

Extensive experience in regulatory inspections and audits,
Our consultants are ex-regulatory inspectors and industry experts, having conducted more than 300 audits each,
Thanks to our international clients we can prepare clients for every regulatory inspection; EU GMP, U.S. FDA, WHO GMP or a combination of these regulatory frameworks,
We know what your clients or the government expects and inspects!
Julian Koster, Business Development

Let me help you explore all the benefits of our services!

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Audit services

PCS prepares, performs and reports the audit directly to the client. The focus of the audit is determined by the client and can include (for example); due-diligence, for-cause, following a complaint, routine, self-inspection, etc. If desirable, PCS can recommend and review CAPA’s following an audit.

Audit services;

Audit preparation
Audit execution
Audit reporting
CAPA definition
CAPA implementation
CAPA implementation check

Auditor training

If you are interested in training your employees in the GMP's or GDP's, have a look at our seminars, in-house training and eLearning.

Who do we need to audit for you?

Outsource your audit to PCS, we usually respond within the hour!

We audit worldwide
Over 800 audits performed since 2010
We respond to audit requests within the hour
We take care of the entire audit process

Contact us

We have the expertise and experience to perform your GxP audits worldwide!

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