GxP Auditing Services
We perform detailed GxP audits of your third party suppliers. We identify the current qualification status, helping you to identify potential risks in your supply chain.
Over 550 audits performed, worldwide!
We perform detailed GxP audits of your third party suppliers. We identify the current compliance status of your suppliers, 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.
Curious to see how we can help you with auditing your suppliers? Plan a call today!
Qualification
Auditing individual suppliers.
Our auditing services include; coordination with the auditee, audit preparation, audit execution (on-site or remote) and reporting.
Program
Supplier qualification program management.
Save time and resources by outsourcing your audit program management to PCS. We perform the risk ranking, prioritize the audits, prep-work, execution and complete follow-up.
Let me help you explore all the benefits of our services!
Audit experience
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. We can perform audits on any continent or country.
We audit any type of pharmaceutical supplier, including (but not limited to); drug products (medicinal products), excipients, active pharmaceutical ingredients (active/drug substances), laboratories, distributors, warehouses, laboratories and software/service providers. Our expertise lies primarily with the EU/WHO/US (C)GxP’s. Other international standards like ICH, PIC/S and ISO 13485 can also be audited against.
Which regulations can PCS audit?
PCS can audit against the United States FDA (C)GMP, World Health Organization GMP, EU GMP, PIC/S and ICH regulatory requirements.
Good Manufacturing Practice (GMP)
Good Laboratory Practice (GLP)
Good Distribution Practice (GDP)
Good Clinical Practice (GCP)
Mock audits
The mock audits can be performed against the EU GMP, WHO GMP or U.S. FDA CGMP.
During the mock audit, and the preparation, the auditor(s) will not only make observations but make recommendations for improvement as well.
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.
