Quality Assurance
We perform GMP or GDP gap assessments of pharmaceutical manufacturers & wholesalers.
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.
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GxP gap assessment
These are some of the recent GxP gap assessment projects we completed for our customers.
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.
