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Dear colleagues
Some days ago I posted the following question:
>I often hear about Good Laboratory Practice (GLP), but the only thing I
>could find are some laws defining GLP from a juridical point of view.
>My question is: is there a handbook giving advice and hints about GLP
>in experimental mechanics and biomechanics? In other words, more than
>for laws, I am looking for recommendations and suggestions for researchers
>and technicians.
=46irst of all I would like to thank all the persons who responded. As
promised, here is an summary of responses that I edited:
Robert Casar (Robert_Casar@50research.ccmail.compuserve.com) indicated that
the "Good Laboratory Practice for Conduct of Nonclinical Laboratory
Studies" is found under Title 21 part 58 of the Code of Federal Registry
(CFR) of the United States government. It's about 20 pages of legalese. The
GLP regs are not a "how to" code, it is a codification of the common sense
practices that researchers adhere to on a day to day basis. One difference
(for most labs) is that it incorporates VERY strict recordkeeping
(essencially a chain of evidence) and quality assurrance oversight. The
main point is that it requires a "Cradle to Grave" paper trail of any
data/study/report that will be used in the support of a device submission
to the United States Food and Drug Administration (FDA). It is designed
ONLY to apply to "Safety" studies. These are interpreted to mean
toxicology, biocompatability, etc. In practice, The GLP regulations are the
only measuring stick that the FDA has, so it often uses the GLPs as the
standard against which data from other types of studies (efficacy,
structural, etc.) studies are compared.
You can order the CFR book with the code in it from the United States Govern=
ment
(21 CFR parts 1-99). It's about US$30. Try calling the FDA ( +1.202.485.0222=
)
and telling them what you want. You may have to call the US Gov't Printing
Office to order it.
Rom Ehmsen (ehmsen@ix.netcom.com) suggested to develop a checklist using
the guidelines published in the U.S. Code of Federal Regulations, Title 21.
Those "regulations" actually implement the "laws" known as the 1976 Medical
Device Amendments to the Food, Drug and Cosmetic Act and the Safe Medical
Devices Act of 1990.
=46or those living in the States, Karl H. Kraus (kkraus@infonet.tufts.edu)
reported that a training course on GLP is offered by Goldman Associates
International, P.O. Box 1853, Rockville MD, 20849.
Geert Lowet (Geert.Lowet@mech.kuleuven.ac.be)indicated a document called
"Bonnes pratiques de laboratoir", which is just the translation in French
of Good Laboratory Practice, edited by the French Ministry of Social
Affairs and National Solidarity (Minist=E8re des affaires sociales et de la
solidarit=E9 nationale), directorate for pharmacolgy and drugs. It is not a
presentation of the laws involved, but a compilation of guidelines which
were formulated by that ministry in 1983 and 1984. Although it aims at labs
involved in the development and evaluation of medication, a lot of its
content can generally be applied. It has a reference number: ISSN 0758-1998
Tochi Omenukor (5nto@qlink.queensu.ca) - and many others - remarked that
laboratory guidelines tend to be based mainly on word of mouth or oral
traditions, repeated from one generation of instructor and technicians to
several generations of students and laboratory investigators. This
situation applied to both hospital and university laboratories; what there
was that was written was generally antiquated or vaguely relevant. It seems
that not much have been published on this topic, apart from the FDA and
similar "juridical" publications listed above. However, there are a couple
of relevant references:
Larry Abraham (l.abraham@mail.utexas.edu) suggested:
Standardizing Biomechanical Testing in Sport, Edited by Dainty & Norman,
Published by Human Kinetics
Robert Casar (Robert_Casar@50research.ccmail.compuserve.com) suggested:
Good Laboratory Practice Regulations, by Sandy Weinberg, 2nd edition
("revised and expanded"), Markel Dekker, New York, NY, 1995
ISBN 0-8247-9377-3
It has some chapters on implimenting GLPs, other contries GLP-like regs, and
some chapters on people from industry on how they implimented the regs.
James Dowling suggested:
"An Introduction to Scientific Research" by E. Bright Wilson, Jr. Dover
Publications, Inc. New York (ISBN 0-486-66545-3). The third edition was
printed in 1990. It is not a biomechanics book but it differs from other
books of research methods because it goes beyond the philosophy of the
scientific method and includes many practical examples of procedures and
techniques.
Thomas G. Loebig (tom@biomechanics.asri.edu) suggested to find some info on
biohazard protection in the following article:
"Control of Transmission of HIV and Other Bloodborne Pathogens in
Biomechanical Cadaveric Testing," by John M. Cavanaugh and Albert I. King,
Journal of Orthopaedic Research, 1990: Volume 8; pages 159-166.
Also, Thomas wrote a lab safety policy for his lab that was required by his
institutional safety department. He said "there is some good general info
plus some that is specific to our institution, but you're welcome to it.
let me know and i'll email or ftp a copy. it's only 32k."
Best wishes to everybody.
Luca Cristofolini
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
Luca Cristofolini
Laboratorio di Tecnologia dei Materiali tel. 39-(0)51-6366864
Centro di Ricerca Codivilla-Putti fax. 39-(0)51-6366863
Istituti Ortopedici Rizzoli E-mail:lk1boq76@icineca.cineca.it
- - - - - - - - - - - - - - - - - - - - - - - - -
Experience is the name we give to our errors.
- - - - - - - - - - - - - - - - - - - - - - - - - - - -- - - - - - - - - -
The opinions here expressed do not necessarily reflect those of my employer
Some days ago I posted the following question:
>I often hear about Good Laboratory Practice (GLP), but the only thing I
>could find are some laws defining GLP from a juridical point of view.
>My question is: is there a handbook giving advice and hints about GLP
>in experimental mechanics and biomechanics? In other words, more than
>for laws, I am looking for recommendations and suggestions for researchers
>and technicians.
=46irst of all I would like to thank all the persons who responded. As
promised, here is an summary of responses that I edited:
Robert Casar (Robert_Casar@50research.ccmail.compuserve.com) indicated that
the "Good Laboratory Practice for Conduct of Nonclinical Laboratory
Studies" is found under Title 21 part 58 of the Code of Federal Registry
(CFR) of the United States government. It's about 20 pages of legalese. The
GLP regs are not a "how to" code, it is a codification of the common sense
practices that researchers adhere to on a day to day basis. One difference
(for most labs) is that it incorporates VERY strict recordkeeping
(essencially a chain of evidence) and quality assurrance oversight. The
main point is that it requires a "Cradle to Grave" paper trail of any
data/study/report that will be used in the support of a device submission
to the United States Food and Drug Administration (FDA). It is designed
ONLY to apply to "Safety" studies. These are interpreted to mean
toxicology, biocompatability, etc. In practice, The GLP regulations are the
only measuring stick that the FDA has, so it often uses the GLPs as the
standard against which data from other types of studies (efficacy,
structural, etc.) studies are compared.
You can order the CFR book with the code in it from the United States Govern=
ment
(21 CFR parts 1-99). It's about US$30. Try calling the FDA ( +1.202.485.0222=
)
and telling them what you want. You may have to call the US Gov't Printing
Office to order it.
Rom Ehmsen (ehmsen@ix.netcom.com) suggested to develop a checklist using
the guidelines published in the U.S. Code of Federal Regulations, Title 21.
Those "regulations" actually implement the "laws" known as the 1976 Medical
Device Amendments to the Food, Drug and Cosmetic Act and the Safe Medical
Devices Act of 1990.
=46or those living in the States, Karl H. Kraus (kkraus@infonet.tufts.edu)
reported that a training course on GLP is offered by Goldman Associates
International, P.O. Box 1853, Rockville MD, 20849.
Geert Lowet (Geert.Lowet@mech.kuleuven.ac.be)indicated a document called
"Bonnes pratiques de laboratoir", which is just the translation in French
of Good Laboratory Practice, edited by the French Ministry of Social
Affairs and National Solidarity (Minist=E8re des affaires sociales et de la
solidarit=E9 nationale), directorate for pharmacolgy and drugs. It is not a
presentation of the laws involved, but a compilation of guidelines which
were formulated by that ministry in 1983 and 1984. Although it aims at labs
involved in the development and evaluation of medication, a lot of its
content can generally be applied. It has a reference number: ISSN 0758-1998
Tochi Omenukor (5nto@qlink.queensu.ca) - and many others - remarked that
laboratory guidelines tend to be based mainly on word of mouth or oral
traditions, repeated from one generation of instructor and technicians to
several generations of students and laboratory investigators. This
situation applied to both hospital and university laboratories; what there
was that was written was generally antiquated or vaguely relevant. It seems
that not much have been published on this topic, apart from the FDA and
similar "juridical" publications listed above. However, there are a couple
of relevant references:
Larry Abraham (l.abraham@mail.utexas.edu) suggested:
Standardizing Biomechanical Testing in Sport, Edited by Dainty & Norman,
Published by Human Kinetics
Robert Casar (Robert_Casar@50research.ccmail.compuserve.com) suggested:
Good Laboratory Practice Regulations, by Sandy Weinberg, 2nd edition
("revised and expanded"), Markel Dekker, New York, NY, 1995
ISBN 0-8247-9377-3
It has some chapters on implimenting GLPs, other contries GLP-like regs, and
some chapters on people from industry on how they implimented the regs.
James Dowling suggested:
"An Introduction to Scientific Research" by E. Bright Wilson, Jr. Dover
Publications, Inc. New York (ISBN 0-486-66545-3). The third edition was
printed in 1990. It is not a biomechanics book but it differs from other
books of research methods because it goes beyond the philosophy of the
scientific method and includes many practical examples of procedures and
techniques.
Thomas G. Loebig (tom@biomechanics.asri.edu) suggested to find some info on
biohazard protection in the following article:
"Control of Transmission of HIV and Other Bloodborne Pathogens in
Biomechanical Cadaveric Testing," by John M. Cavanaugh and Albert I. King,
Journal of Orthopaedic Research, 1990: Volume 8; pages 159-166.
Also, Thomas wrote a lab safety policy for his lab that was required by his
institutional safety department. He said "there is some good general info
plus some that is specific to our institution, but you're welcome to it.
let me know and i'll email or ftp a copy. it's only 32k."
Best wishes to everybody.
Luca Cristofolini
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
Luca Cristofolini
Laboratorio di Tecnologia dei Materiali tel. 39-(0)51-6366864
Centro di Ricerca Codivilla-Putti fax. 39-(0)51-6366863
Istituti Ortopedici Rizzoli E-mail:lk1boq76@icineca.cineca.it
- - - - - - - - - - - - - - - - - - - - - - - - -
Experience is the name we give to our errors.
- - - - - - - - - - - - - - - - - - - - - - - - - - - -- - - - - - - - - -
The opinions here expressed do not necessarily reflect those of my employer