Good Laboratory Practice
Quality Assurance at SafePharm
SafePharm
Laboratories is a compliant facility within the UK
government monitoring programme. All work is done according
to GLP standards, whether GLP
compliance is a requirement or not.
GLP Compliance monitoring for the UK government,
for all types of chemicals
(including pharmaceuticals, agrochemicals and general chemicals),
and all test types, is carried out by the Medicines Control
Agency within the Department of Health (formerly the Department
of Health and Social Security). These inspections fully implement
the requirements of the relevant European Commission Directives.
Inspections take place approximately every
two years, the the last inspection at SafePharm being in Autumn 2007. It is our policy to include a current GLP Monitoring
Authority Statement in each study report for which we claim
GLP compliance.
The Quality
Assurance Unit is composed of a team of 18 staff and
the Head of Quality Assurance, who reports to the Managing
Director. The Head of Quality Assurance has been involved
with GLP Quality Assurance prior to the publication of the
first GLP's by the United States FDA in 1978, and included
11 years with a multinational company before joining SafePharm
in 1989. Other staff are selected for a mixture of scientific
background and the capacity for sustained concentration in
matter of detail.
The work of the Unit is to provide assurance
to Management and Study Directors that the requirements of
the UK GLP Regulations are met. However, account is also taken
of other national GLP standards, and where relevant, Study
Directors are advised of additional requirements. Most of
the staff of the QAU are
members of the British Association
of Research Quality Assurance (BARQA).
Please view our present certificate
here.
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