For Pharma & Biotech

Auditing services

We perform audits of suppliers and contractors in the pharmaceutical industry. Our auditing services are worldwide and cover every major regulatory framework.

Auditing services include; coordination with the auditee, audit preparation, audit execution (on-site or remote) and reporting.

Why you should choose PCS for your supplier audits

  1. We audit worldwide
  2. We respond to audit requests within the hour
  3. Highly experienced, we've performed 600+ audits since 2010
  4. We take care of the entire audit process
Auditor inspecting a pharmaceutical api producer reactor vessel

Who do we need to audit for you?

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

  1. We audit worldwide
  2. We respond to audit requests within the hour
  3. Over 600 audits performed since 2010
  4. We take care of the entire audit process

Contact us

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

We usually respond within 1 hour or working day!

Julian Koster

Business Development

Which regulations can PCS audit?


Good Manufacturing Practice (GMP)

Auditing pharmaceutical manufacturers, importers or contract laboratories against the GMP's.

EU, WHO or U.S. FDA.


Good Distribution Practice (GDP)

Auditing warehouses and distributors of medicinal products against the GDP's.

EU


Good Laboratory Practice (GLP)

Auditing pharmaceutical laboratories and contract laboraties against the GLP's.

EU or U.S. FDA.


Good Clinical Practice (GCP)

Auditing clinical trial providers against the GCP's.

EU, WHO or FDA.

Our audit experience

PCS has a large team of qualified GxP 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.

Our experience makes us the ideal partner to outsource your audit program to. PCS' international scope allows us to be flexible, fast and deliver high quality audit reports. During COVID-19 we can perform audits on any continent or country, requiring only local travel.

We audit any type of pharmaceutical supplier, including (but not limited to); excipients, active pharmaceutical ingredients, laboratories, distributors, warehouses, laboratories and software providers. Our expertise lies primarily with the EU/WHO or U.S. FDA GxP's. Other international standards like IPEC, EXCiPACT, ISO 13485 and PIC/S can also be audited against.

Download our whitepaper

Download our FREE whitepaper to learn more about our auditing services!

Audit solutions

Our audit solutions are flexible. You can outsource any number of audits or your entire supplier qualification program to PCS.

Whether it's a private or shared audit, our experienced auditors will ensure flawless execution and reporting. We can also train your auditors on auditing best practices or qualify your auditors.

Auditor training

PCS has been organizing audit training since 1993. We can train individual auditors or corporate auditing teams.

If required, PCS can qualify you auditors. We have organized qualification training sessions for the global audit teams of Novartis and SunPharma.

Workers at work on the production line for manufacturing of ampule medications

Mock audits

We perform mock audits of companies to prepare for regulatory inspections or client audits.

The mock audits can be performed against the EU GMP, WHO GMP or U.S. FDA GMP. During the mock audit, and the preparation, the auditor(s) will not only make observations but make recommendations for improvement as well.

Because we make recommendations during the audit, your staff is able to define better and more accurate CAPA's.

We are happy to help!

Feel free to contact us if you have any questions about our audit services, audit training or the GxPs in general. We usually respond within 1 hour or business day.

  1. We audit worldwide
  2. We respond to audit requests within the hour
  3. Over 600 audits performed since 2010
  4. We take care of the entire audit process

Contact us

We usually respond within 1 hour or working day!

Julian Koster

Business Development

  • Woerden, 3447GM, the Netherlands