Or who audits the Auditors?
The UK GLP monitoring authority in 2015 issued guidance on their expectations that the quality assurance programme is included in GLP facilities audit schedule. A few organisations outside of the UK have applied this guidance but not many. But why should you include the QA programme in your facilities audit schedule?
Why audit QA?
- The UK GLP monitoring authority were raising deficiencies due to inappropriate quality assurance programs.
The most recent deficiency data available (from 01 Apr 2017 to 31 March 2018) reports 14 major deficiencies were attributed to quality assurance with the two highest incidences related to management of the QA programme and study based/critical phase audit programme. Of the 469 other deficiencies over 50 were assigned to quality assurance.
- The quality assurance programme is part of the GLP facility quality system and like other processes should be subject to independent oversight.
Who is responsible?
The responsibilities of Test Facility Management include ensuring that there is a quality assurance programme with designated personnel and ensure the quality assurance responsibility is being performed in accordance with the principles of GLP [Schedule 1, Part I, 1.-(1)(f) and 1.-(2)(f)]. Failure to establish an appropriate quality assurance programme is one of the underlying causes of deficiencies.
Therefore, test facility management should establish a mechanism to confirm that their quality assurance programme complies with the requirements of GLP, and that the QA function is complying with established documented procedures.
Who audits QA?
As with any audit, the review of the QA programme and function should be undertaken by an individual(s) who is independent of any of the functions or activities that are being reviewed. Test facility management are responsible to determine how this may be best achieved.
Options include
- test facility management,
- member of facility staff
- independent consultant..
Whoever, conducts the audit of QA must be directly responsible to management and be suitably trained and experienced
What should be included?
The QA programme should be assessed for compliance . The Knowlogy has produced a checklist.
Don’t forget the audit programme should be assessed that each GLP study is subject to an appropriate level of QA oversight and include the definition and justification of critical phases.
Are you onboard?
For further advice on auditing your Quality Assurance Programme speak to a member of The Knowlogy team. We’d be happy to help!