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Dear All,
I would like to know what kinds of GLP certifications required for a laboratory to be
eligible to perform PK bioanalytical analysis for Phase I/II clinical trials. Basically, I
think that PK blood samples will be collected, processed, and stored in the GLP-certified
Biospecimen Core, and then only frozen plasmas aliquots for PK study will be shipped to
the lab for sample analysis using HPLC and possibly PK data analysis as well.
I appreciate your response.
Sue
Sukyung Woo, Ph.D.
Assistant Professor
Dept. Pharmaceutical Sciences, College of Pharmacy
University of Oklahoma Health Sciences Center
1110 N. Stonewall Ave. CPB 331
Oklahoma City, OK 73117
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Dear Sue,
Regarding GLP certifications, no certifications are required in the US. A lab claims
compliance with GLPs, and then audits by the sponsor QA and by the FDA reveal any
deviations (serious or other). The audits determine acceptability of the results from a
given study. In cases of a pattern of serious noncompliance, the FDA may refuse to accept
data from a lab in general. So in the US, Labs may not know that something is not
acceptable until after an FDA audit. They must rely on their own internal knowledge and
audits, as well as those of sponsors, to meet GLP requirements.
As far as I know, the situation in Europe is somewhat different. National regulatory
agencies for EMA member countries have regularly scheduled audits of laboratories, and the
results of the audits either confirm GLP compliance (along with issuance of
certification), or GLP noncompliance and no issuance of certification. Data from a lab
that has been certified has a relatively low risk of data being found to be unacceptable
by regulatory authorities, because their practices in general have been found to meet
requirements..
Thomas L. Tarnowski, Ph.D.
ttarnowski1.-a-.aol.com
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The following message was posted to: PharmPK
Sue, Tom Tarnowski's nice response addresses lab certification. You'll want to be familiar
with IT validation and regulatory submission requirements surrounding PK data analysis and
reporting. They're not hard, but they're not trivial either, especially in terms of the
amount of resource to design, implement, document and maintain.
The importance of careful attention to the details of lab conduct is reinforced by the
unfortunate recent events at Cetero's lab, for which there are ample on-line citations.
It's also good practice for any lab to routinely access and review what's going on as
evidenced by Establishment Inspection Reports (EIRs) and FD-483's that can be retrieved
under the Freedom of Information Act (FOI). These give insight into current regulatory
expectations and practice, including shades of meaning or interpretation within guidance
statements that may affect their implementation.
with regards,
-dean
Dean W. Knuth
President & CEO
Jasper Clinical Research & Development, Inc.
526 Jasper Street
Kalamazoo MI 49007
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The following message was posted to: PharmPK
Depends on what and where. GLP is a regulated activity in the US but does not
require licensure. Clinical support is GCP and safety profiling is CLIA (or
Regulated by a similar body). EMA offers GLP certificates as does Iso. The
former is toothed, the latter much less do. Basic prudence is to determine an
review reputation of the labs and the individuals working there. As Tom
suggests, 483s are a public way to review labs performance but may often be
late.
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