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Sponsor Responsibilities
Quality assurance and quality control ...
ICH GCP Section 5.1.1.
The sponsor is responsible for implementing and
maintaining quality assurance and quality control
systems with written SOPs to ensure that trials are
conducted and data are generated, documented
(recorded), and reported in compliance with the protocol,
GCP, and the applicable regulatory requirement(s).
ICH GCP Section 5.1.3.
Quality control should be applied to each stage of
data handling to ensure that all data are reliable and
have been processed correctly.
WHAT IS QUALITY ASSURANCE?
SOP’s
Proactive Quality Assurance:
* Performing SOP training
Retroactive Quality Assurance:
* Ensure quality by performing
audits
Quality Control (QC)
The Operational techniques and activities undertaken
within the quality system to verify that the requirements
for quality of the trial related activities have been
fulfilled (ICH 1.47)
Systematic - continous
Sampling process
What is an audit ?
A systematic and independent examination of
trial related activities and documents to
determine whether the evaluated trial related
activities were conducted, and the data were
recorded, analysed and accurately reported
according to the protocol, sponsor’s SOPs,
GCP and the applicable regulatory
requirement(s).
(ICH Section 1.6)
How is audit Different from
Monitoring
Investigator Site
Local Operating Company (LOC)
System
CRO and service providers
Facilities conducting Early phase studies
Investigator site audit
Feedback will be Site will have the possibility
provided throughout to correct minor deficiencies
the audit during the course of the
+ Advise / Training audit
Usually
1 day
review
in-
house
files at
LOC
3 categories :
Critical : Compromised study
Major : Seriously deviates from standard / prompt
corrective action
Others : Deviates from standard / action
Critical Observation
Validity / integrity of data / product and/or
study conduct / system are compromised.
Critical observations may require that
further operations stop until corrective
action is complete.
The observation has the potential to render
the data for a regulated study, submission,
or facility invalid as it is a deviation from
the regulations and does pose a significant
business risk
Observations
Major
Seriously deviates from accepted standard
Requires prompt corrective action
Operations can proceed
May result in regulatory citation
Other
Deviates from accepted standards
Corrective action required
– Within time agreed by owner/auditor
– To improve quality of documents, processes
– To prevent potential decrease in quality or
compliance
How to respond to an audit?
Check if the correct Owner identified?
If co-ownership with Central functions
– Study Central Contact or Process Owner or
Department Head
Determine who coordinates responses (usually
Monitor)
How to respond to an audit?
Agree / Disagree to observation
- 15 +20 (counting
from Draft)
Confidentiality
MUST NOT
– Be placed in study files
– Be kept electronically (email,
personal PC, shared drive) - Except
C&T
– Be forwarded to additional
personnel unless there is a specific
need
Audit Certificates
Confirmation by auditor that audit has
taken place.
Issued for individual study or system
audits.
The certificate should make no statement
of degree of compliance noted during the
audit. When filed in the study file it
mentions QA activity but not the audit
report.
One single certificate per study
– Request at least 2 weeks in advance
For cause Investigation
Significant cause for concern with the conduct of the
trial such that subject safety and/or validity and integrity
of data may be compromised
Serious Misconduct
– Poor study conduct whether intentional or
otherwise, where there is persistent non-
compliance with GCP
Some „For Cause‟ Indicators
Pre-approval
- New Product marketing application, part of
assesment
– study / project-specific: verify if trial was
conducted, data generated, documented and
reported in compliance w/ protocol, GCP and
sponsor SOPs
Routine GCP
– System inspection: evaluate QA/QC
systems established by sponsor to assure
that trials are conducted and data
generated, recorded and reported in
compliance with protocol, GCP and
applicable reg. requirements
Triggered / directed / for-cause
– complaint
– poor compliance w/ regulatory
requirements
Any Questions ?