TRAINEE - World Health Organization

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TRAINEES Chapter 6 • GLP Training Manual
QAU often has the responsibility of reviewing SOPs. In those laboratories where the
QAU signs the SOPs, it is to indicate that the SOP is GLP compliant, complete, clear
and not in conflict with other SOPs that exist on the research site – this is not a mandatory
duty.
Planning (Master Schedule, Inspection Plan)
Once the protocol is signed and distributed, the study is entered onto the master
schedule sheet (MSS), a list of all studies at the facility. The maintenance of the MSS
may or may not be a QAU function. However QAU must be aware of all planned
studies and must have a copy of, or direct access to, the MSS.
The QAU plans the inspections and audits considered necessary to support the
study, if necessary, with input from the study director. There are arguments for and
against performing unannounced QA inspections but usually inspections and audits
are planned with the study director or his representative.
The QAU maintains its own inspection and audit plans study by study. These study
specific inspection targets are entered onto a planning system in the QAU department
along with facility/system and process inspections. This is to allow for overall planning
and the most efficient organization of QAU resources.
Audits and Inspections
An audit or an inspection is a methodical evaluation that should be performed in
cooperation with the people concerned. The internal audit is not an inquisition or a
punitive exercise.
In addition to the QAU review of planning activities, the QAU performs three types
of audits/inspections:
– Study-based inspections/audits.
– Facility/systems-based inspections/audits.
– Process-based inspections/audits.
QA may also inspect contractors and suppliers.
Study-based Inspections/Audits
Inspections are performed as planned with additional or follow-up inspections if
necessary. There are numerous useful guides on inspection and audit techniques.