MHRA GMP Compliance for the Manufacture of API’s for Clinical Study

High Force Research Ltd is pleased to announce that the Medicine and Health Regulatory Agency (MHRA) inspection held in December 2019 has resulted in the company retaining their GMP Compliance status for the manufacture of API’s for clinical study.

This inspection assessed our compliance with GMP principles, reviewing various client study files and evaluating our Quality Management System.

HFR’s Head of Quality, Zoe Hudson, said

“ We are very pleased with these results which confirm our commitment to provide clients with the highest standards of quality.”

The MHRA is the regulatory body within the UK which scrutinises all licensed medicines in the UK to ensure that medicines meet acceptable standards on safety, quality and efficacy, and therefore protect the health of the public. It audits all companies working within this area to assess the compliance of the facilities with GMP and to assure the integrity of the data being submitted.

Having a successful audit confirms that a facility is working in compliance with GMP and gives clients added confidence in the work performed on their behalf.

To further streamline the quality service already offered to the life science community, HFR has recently installed the digital quality management system QPulse from Ideagen which will further enhance our operational processes giving greater control and visibility of organisational and business critical documentation.

Zoe added:

“Although we are immensely happy with the MHRA findings we are always looking for ways to improve.”

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