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Do any sponsors that contract method validations to a CRO conduct their
own Quality Assurance audit of the validation for bioanalytical method
that will support clinical studies. Since the CRO is responsible for QA
auditing per their SOPs, is an additional QA audit necessary?
Thanks - Dave
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Dear Dave-
Regarding sponsor audits of method validation:
1. Method validation is not strictly a GLP nor GCP activity, and
therefore QA audit is technically not required by the FDA.
Nevertheless, most CRO's include some level of audit of such work by
their QA. When you place such work at a CRO, you should ask what, if
anything, is included as their QA auditing process for the work. Then
you can engage your own QA and decide whether or not to include a
sponsor QA. In general, I am in favor of some sort of QA review for
validations of bioanalytical methods to be used for GLP or clinical
studies.
2. It would be good to have an SOP for your (sponsor) organization that
indicated when to trigger a sponsor audit.
3. You should conduct an initial audit of any CRO for which you plan to
have perform method validations and GLP/GCP work, and perform re-audits
on a regular schedule (e.g., every 2 years). This process should be
noted in a Sponsor SOP. It's best to have both a sponsor QA auditor and
a sponsor subject matter expert (technical expert) at the audit. The
level of the CRO QA auditing should be discussed during the audit, so
that you can plan accordingly.
4. If you decide to include a Sponsor QA audit of any work, you need to
let the CRO know up-front, so that the added time can be included in
timeline planning, and so that the CRO knows that there may be things
they need to do even after their own QA is finished.
5. In the organizations that I have been associated with, generally our
QA has assigned QA review for such work (both validations and study
sample analyses) to the CRO QA. It is extra work for the sponsor QA,
and it is duplicative work, especially after the initial audit shows
that the Sponsor QA is satisfied with the CRO QA. When unexpected
events occurred, I always consult with my own Sponsor QA to make sure we
both agree on the course of action. However, it is very rare that my
own QA actually wants to review the work/deviation/action in a formal
way (e.g., putting something on the master schedule, noting in the
report that the review took place, etc.).
-Tom
Thomas L. Tarnowski, Ph.D.
Corporate Liaison & Special Tasks Director
Organizing Committee
CACO Pharmaceutical and BioScience Society
ttarnowski1.-at-.aol.com
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David,
Sponsors will audit a CRO to ensure that the CRO has procedures and
controls in place to comply with the appropriate regulations (e.g. GLP,
GCP, ICH, etc.). Often a quality assurance group will perform the audit;
however the audit of the CRO is not based on checking compliance of the
CRO to their SOPs. Instead, the audit demonstrates that the sponsor has
appropriate oversight, and it gives the sponsor assurances that the CRO
will perform work in a way that is acceptable for regulators.
Generally a sponsor will audit a CRO once before work commences, and
then update the audit every 2-3 years.
I hope that is helpful.
Best of luck,
Nathan Teuscher
--
Nathan S. Teuscher, PhD
Founder, PK/PD Associates
www.learnpkpd.com
nathan.-at-.learnpkpd.com
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The following message was posted to: PharmPK
Dear Dave,
I work in an Spanish CRO called Dynakin which offers bioanalysis
services in compliance with GLP. We perform QA inspections in all
studies following the QA programme, and we also have the inspection from
the Spanish Agency each 2 years.
Regarding the Sponsors, it is a common practise to receive a
pre-contract audit before the begining of any study and repeat it
periodically (each 2 years for example). However, we also have study
inspections from the Sponsor (less common, and not for all studies).
Regards,
Valvanera
Dr. Valvanera Vozmediano
Dynakin, S.L.
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