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Apply Good Manufacturing Practices, GMP Audits to Ensure Compliance

Outsource your GMP and GDP audits to PCS. We audit pharmaceutical suppliers against the GxP's, worldwide. Get insight into the qualification of your suppliers through PCS' audit services.

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Abbott
Roche
Pfizer

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Why choose PCS for your next GxP audit?

  • We audit pharma suppliers worldwide
  • We prepare, perform and report the audit
  • We can audit against the GMP, GDP, GLP and GCP guidelines
  • Experience in EU, WHO GMP and U.S. FDA regulations

Supplier qualification audits

We conduct detailed GMP audits of your suppliers. Our good manufacturing practice audits are performed worldwide.

We find current and future GMP compliance problems and help you determine potential risks in your pharmaceutical supply chain.

Clients ask us to qualify suppliers and contractors in the pharmaceutical and biotech industries against the GMPs. Our audit services are global and encompass every major regulatory framework, including the EU GMP, EU GDP, EU GLP and EU GCP guidelines. The U.S. FDA GMP code of federal regulations and WHO GMP requirements.

GMP Audit Services

PCS can perform GMP audits of individual suppliers or assume full responsibility for your entire supplier qualification program.

The suppliers we can audit against the GMP's

  • Pharmaceutical CMO's (contract manufacturing organizations),

  • API and excipient manufacturers,

  • Distribution and warehousing organizations,

  • Intermediates,

  • Service providers,

  • Contract laboratories.

Audit process

PCS prepares the GMP audit, carries it out and reports it directly to you. The focus of the GMP audit is determined by the client and can include (for example); due diligence, for-cause, after a complaint, routine, self-inspection, etc. If desired, PCS can recommend and assess CAPAs after any GMP audit.

Experience

PCS has a large team of qualified GMP auditors. With extensive experience in running international audit programs. We have organized and executed corporate audit programs for a number of multinationals like Sandoz, Novartis and Norgine International.

Jaap Koster, CEO of PCS, avatar

GMP auditing in the pharmaceutical industry ensures compliance and product safety. Effective auditors must blend theory with a keen understanding of human behavior to assess adherence and inspire commitment to GMP quality standards.

Eng. J.J.M. Koster
CEO of PCS

Audit program management

Looking to outsource the management of your third-party GMP audits? PCS has managed the GMP audit program of a number of pharmaceutical organizations such as Novartis, Sandoz, the Dutch Ministry of Health and Norgine. We can assume the entire supplier qualification program, or part thereof.

Looking for an independent GMP gap analysis?

Besides GMP audits of suppliers, PCS can perform a gap analysis of your organization against every major regulatory GMP framework. The scope of the gap analysis determines the scope. You have the option to choose between a "regular" auditor or an ex-regulatory inspector from the EU GMP or the U.S. FDA.

Gap assessments usually last between 1 to 3 days and are concluded with a comprehensive report. Depending on your requirements, PCS may also assist with CAPA definition and recommendations.

All gap assessments are performed by seasoned industry & regulatory experts.

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Frequently asked questions

How many years of experience do your auditors have?

This depends per audit, but in general PCS only works with auditors with at least 10 years of experience. Our auditors are qualified auditors.

How many GMP/GDP audits has PCS performed?

PCS has performed more than 550 GMP/GDP audits since 2010, mainly of suppliers of Active Pharmaceutical Ingredients and logistics providers (3PL's).

How long does a GMP or GDP audit typically take?

This mainly depends on the size of the manufacturing facility and the cause of the audit. Large manufacturers may take up to three days. While small facilities receiving a regular qualification audit may only need one day. On average, our audits require 1 day within the EU, outside the EU the average duration is 2.5 days.

In which countries does PCS perform audits?

PCS can perform GMP/GDP audits worldwide, with notable exceptions being Russia, North Korea, Syria and Afghanistan. All other countries can be serviced by PCS team members or associates. In the EU, besides GMP and GDP audits, PCS can perform GCP and GLP audits as well.

How does the audit process work when I want to outsource an audit to PCS?

We would first request a few details from you including; 1. the reason for the audit, 2. the auditee's location, 3. the product the auditee produces for you, 4. the scope and the timeline. With this information, PCS will produce an offer for review. This offer will contain all the costs, the timeline, the deliverables and the auditor. If desirable, a call can be planned with the auditor in advance. Once the offer is signed, the audit is prepared by requesting documents from the auditee such as the SMF, QM, etc. The auditor will travel to the site, perform the audit and conclude with a summary. Within 21 days, the full audit report will be sent to you for review.

Get started with our GMP audit service!

We are a pharmaceutical consultancy dedicated to quality and patient safety. Are you looking for a GMP audit or a GDP audit? We have the expertise and experience to help you perform these audits. Feel free to contact us if you have any questions about our audit services or GMP/GDP in general.

  • We audit pharma suppliers worldwide
  • We prepare, perform and report the audit
  • We can audit against the GMP, GDP, GLP and GCP guidelines
  • Experience in EU, WHO GMP and U.S. FDA regulations
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