|
Quality Assurance
The Sequani Quality Assurance Unit is a dedicated group responsible
for the monitoring of studies. The Unit is independent of those
personnel conducting the studies and is responsible for assuring
Management that the facilities, equipment, personnel, methods,
practices, records and reporting are in compliance with the relevant
good practice, GLP or GCP.
Sequani is a member of the United Kingdom
Good Laboratory Practice Compliance Programme and performs
toxicology/pathology studies in compliance with current UK and OECD
GLP regulations and requirements. In addition, Sequani Clinical
performs trials in human subjects in compliance with ICH requirements
for Good Clinical Practice.
Sequani welcomes inspection by its customers
and is always pleased to make the necessary arrangements for such a
visit.
QA
Resources
The Quality Assurance Unit has a full time staff of dedicated
personnel. Each auditor brings with them a wealth of expertise and
experience in science, technology and industry. This, together with
the training and development programmes provided in-house and thorough
professional bodies such as BARQA, enables our auditors to have a
proper understanding of the studies conducted and a full knowledge of
the relevant regulations and the role of quality assurance.
The auditors are supported in their roles by the QA administrator
who is responsible for co-ordinating the Sequani Standard Operating
Procedure system.
QA Audits
The Quality Assurance Unit reviews all study
protocols before issue; schedules and performs critical phase and
process inspections on studies; performs facility, supplier and sub
contractor inspections; and finally reviews each and every study
report for completeness and accuracy and for compliance with GLP and
or GCP.
|
