Quality Assurance

Gap Assessment

We perform GMP or GDP gap assessments of pharmaceutical manufacturers & wholesalers.

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What is a gap assessment?

A gap assessment is a check of your Quality Management System (QMS) against the GxP’s. One or more expert consultants perform this gap assessment at your site and write a comprehensive report afterwards. A gap assessment usually lasts between one to nine days, depending on your product type(s) and the scope of the GxP gap assessment.

How does a gap assessment work?

The scope is discussed,
An offer is made for the gap assessment,
Offer accepted? PCS sends a gap assessment agenda,
Quality system documents are requested for review,
The gap assessment is conducted on-site or remote,
A report containing observations and recommendations is written,
The report is submitted to the client for review,
(optional) PCS checks the client's CAPA's and their implementation.

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

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Regulatory frameworks

PCS can perform a gap assessment against any major international regulatory GxP framework. We are specialized in the following GxP regulatory frameworks:

  • European Union GMP,
  • U.S. FDA GMP,
  • World Health Organization GMP,
  • PIC/S GMP,
  • ICH GMP.


We can assess the following industries against GxP gaps.

  • Pharmaceutical,
    • Finished Product,
    • Intermediates,
    • API,
    • Excipients.
  • Biotechnology,
  • Chemical,
  • Food,
  • Medical
    • Hospitals,
    • Pharmacies.

Have a question about our gap assessment services?

We’re here to help! We usually respond within 1 hour or business day.

Extensive EU GMP, WHO GMP & U.S. FDA GMP experience,
We help clients worldwide,
We respond to gap inspection requests within the hour
We provide actionable improvements in our gap assessment reports,

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We have the expertise and experience to perform highly beneficial gap assessments worldwide!

Jaap Koster
Jaap Koster

Senior GMP & GDP Consultant

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Available M-F: 09:00 AM to 5:00 PM

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