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Dear Group,
This is regarding signing of GLP Documents particularly in the area
of bioanalysis.
Keeping my view point aside, would like to ask the group about the
procedure of signing in all clinical and non-clinical study protocols
and study reports, the same is also applicable to method validation
protocol, method SOP and method validation report.
For all kind of submission studies, can the person second in line to
whom the Principal Investigator (PI)/HOD has given written
authorization (and which is already well documented in the form of a
written control document of Duty Delegation) put his/her signature on
signatory page of the protocol(s)/report(s)/method SOPs on behalf of
PI/HOD in case the PI/HOD is on leave/away from the office? Is it
accepted by US FDA? Does FDA or any other regulatory body objects if
the document is being signed by his/her designee. Is it mandatory
that the PI only has to sign on the page where his/her name is
appearing in the document(s). Is this addressed in any of the FDA or
other regulatory documents?
Any information/comment on this is highly appreciated.
Thanking you in advance
Regards
Neel Kamal Mohan
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The following message was posted to: PharmPK
Dear Mr. Mohan,
In my view, if the second liner is also from the same field and has
enough documented training for that particular activities then there
is no visible problem to sign the protocols in absence of PI/HOD as he/
she is the only authorized person to do the same.
Hope this will suffice your requirements
Other group members can also enlighten the topic, as this is one of
the most debatable topic.
Thanx & Regards
Chintan Patel
Pharmacology & Toxicology
Cadila Pharmaceuticals Limited
1389, Trasad Road
Dholka - 387 810
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Dear Mr. Chintan,
We are talking about signing technical documents and it is therefore
essential that the person has to have sound and adequate knowledge to
understand the intricacies of the projects apart from having
documented authorization/training to perform that task. Only
technically competent person can do justice for this job and PI/HOD
has to designate this person not only from the same field but also has
to be from the same department.
Regards
Neel Kamal Mohan
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That is inappropiate reccomendation in event of absence of a first
liner there should be a deputy to a first linner who is also a first
linner to sign the document.
s.o.o
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Regarding designating alternative signors:
The way this has worked for me in the past is first to have the
authority for signature defined in an SOP, and to define it in terms
of a Positions (not peoples names). For example, signing a type of
document can be the Director or the Deputy director, or their higher
management. The SOP also allowed delegation of signing authority by
the Director was to be absence (by signed advance memo of the
Director). In cases where the SOP said that the deputy could sign for
the Director (e.g., John Doe) in his absence, the signor would sign
his/her name with the added printed notation "for John Doe." We always
got buy-in from QA so that they understood and agreed with the process
before it was implemented.
This is not an easy question, but we never got any citations for this
practice. Of course no guarantees for future audits!
Tom
Thomas L. Tarnowski, Ph.D.
Bioanalytical Development
Elan Pharmaceuticals, Inc.
800 Gateway Boulevard
South San Francisco, CA 94080
thomas.tarnowski.-at-.elan.com
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The following message was posted to: PharmPK
You are right but the deputy also from the same area and has same
expertise so with proper documentation the deputy will be a first
liner automatically. So he can sign the documentation, you can not
held the projects only due to absence of any one person. You can also
mention it in protocol that in absence of the PI, second liner will
act as a PI
CD
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Dear Mr. Neel Kamal,
Yes, that's the requirement, flow of activities it should define very
clear and always keep the next line competent managers in the GLP
organogram from every discipline concern project related studies. In
2003 regarding the same, debate has been taken place during OECD
countries meet.
Regards,
Korlapati V Rao
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Dear Mr. Venkatesh,
Thanks for sharing your views. I understood what you intend to say
regarding the flow of activities and organogram but I could not
clearly understand your viewpoint on this. As I mentioned,
authorization is well documented in the duty delegatation control
document and in the departmental organogram. Would it be possible for
you to elaborate your statement more clearly and an answer with
reasons either agreeing or disagreeing to what I asked would probably
help this forum to be more open for a conclusive discussion. Do you
have the outcome of that OECD workshop/debate held in 2003? Could they
reach to any common consensus as to what should be done and followed?
Thanks & Regards
Neel K Mohan
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dear,
For report he can sign as designee, for Method SOP he can sign as a
designee,
but for the protocol should be sign only by PI/CI/study director in
case or preclinical due to it should be written responsiblity of them
and essential requirement of GCP/GLP. due to written charge handover
is only be done for inhouse procedural documents. i.e. designee never
can sign the form 1572 on behalf of PI. as per my experience the
signature in protocol by designee instead of the PI/CI/Director never
be accepted by any regulatory.
apart from protocol signing any documents can be sign by any designee
who is delegate by PI and trained by PI.
regards,
paresh mistry
DGM-Quality Unit
ARL-AHD,
india
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