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Quality Assurance and Quality Control
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QA and QC are headed by Quality Assurance Manager Karina Elkjær.
PKC’s quality system is in compliance with ICH’s Guidelines Q7, which enables PKC to manufacture products according to cGMP regulations.
The Danish Health Agency inspects the facility every three years and issues a GMP-certificate upon approval.
In addition, PKC is inspected on a regular basis by the United States Food & Drug Administration (US FDA).
Customers are always welcome to audit our facility.
The QC-laboratory is equipped with state-of-the-art instruments and staffed by highly skilled and experienced personnel to analyze and constantly develop new analyses for the broad range of techniques and products PKC offers. |


