13.4 Scope of QA activities
Internal consulting
QA auditors are often consulted for advice in GCP
because of their broad and profound expertise in
the regulations. As they acquire knowledge in
many areas and oversee a variety of different clin-
ical trials, QA auditors are often requested for
information and clarification. This way of interac-
tion with employees and auditees is an opportunity
for preventing errors before they occur and for
fostering communication between operational
staff and QA. Auditors remain aware of day-to-
day challenges in clinical research and learn early
on about potential misinterpretations.
Auditing
QA auditors’ core responsibility is to conduct
audits in the various areas in clinical research.
This requires the set up of an audit program
which should be based on the clinical development
plan for the substance(s), previous experience
gained in audits and the importance of the trials
in the light of a marketing submission. Ideally, the
audit program should cover all clinical trials.
ICH GCP (1995) defines an audit as ‘A systema-
tic and independent examination of trial-related
activities and documents to determine whether the
evaluated trial-related activities were conducted,
and the data were recorded, analyzed and accu-
rately reported according to the protocol, spon-
sor’s SOPs, GCP and the applicable regulatory
requirement(s)’.
The benefit of audits can be maximized if they
are performed during the active phase of a clinical
trial (e.g. when trial subjects are recruited and
treated), so that deficiencies can still be corrected.
Training
QA auditors are often actively involved in
providing training on GCP and regulatory topics
related to clinical research. They gain first-hand
experience regarding interpretations, shortcoming
and problem areas when conducting audits.
This knowledge is a valuable resource to tap in
trainings.
QA auditors should assess, for example during
audits, if adequate programs for induction training
and continual education are established and fol-
lowed. It has been observed that in some compa-
nies the QA department has been made responsible
for maintaining the training files for all employees
and for ensuring that training plans are available
and training courses are attended.SOP management
QA auditors are often tasked with responsibilities
related to SOP management, such as maintaining
originally signed versions, managing the dissemi-
nation (electronically and as hard copies), organiz-
ing SOP reviews (scheduled and ad hoc) and,
sometimes, even writing SOPs for departments
other than QA.
SOP review by QA auditors is certainly recom-
mended before issue to ensure the SOPs are consis-
tent with applicable international, country-specific
and regional regulations, ICH guidelines (not lim-
ited to ICH GCP) and company policies and proce-
dures.
SOPsareconsideredcontrolleddocumentsand as
suchrequireasystemwhichcontrolsthedistribution
of SOPs to ensure that only current versions are
accessible for use. Outdated documents should be
retrieved and identified as historical. It is QA’s
responsibility to verify that this system is being
followed and is effective. Deficiencies in the SOP
system are usually attributed to a lack of control and
weaknesses of a company’s QM system.Inspection readiness
The frequency of GCP inspections is increasing
with many countries having established GCP
inspectorates over the past years. Inspections can
occur at sponsors, at investigator sites, labora-
tories, CROs and other external providers. GCP
inspectors may assess compliance with regula-
tions, protocol requirements and SOPs at various164 CH13 QUALITY ASSURANCE, QUALITY CONTROL AND AUDIT