GIQAR position paper on ‘Archiving and Good Laboratory Practice’†
Corresponding Author
M. M. Brunetti
RTC, Research Toxicology Centre SpA, Pomezia (RM), Italy
Head of QAU, RTC, Research Toxicology Centre SpA, Via Tito Speri 12, 00040 Pomezia (RM), ItalySearch for more papers by this authorM. Astolfi
RTC, Research Toxicology Centre SpA, Pomezia (RM), Italy
Search for more papers by this authorE. Corbascio
CTI Cell Therapeutics Europe S.r.l., Bresso (MI), Italy
Search for more papers by this authorM. Filippone
ACRAF SpA Angelini Group's Company, S. Palomba, Pomezia (RM), Italy
Search for more papers by this authorE. Invernizzi
Istituto di Ricerche Biomediche ‘Antoine Marxer’ RBM S.p.A., Colleretto Giacosa (TO), Italy
Search for more papers by this authorR. Lasala
Istituto di Ricerche Biomediche ‘Antoine Marxer’ RBM S.p.A., Colleretto Giacosa (TO), Italy
Search for more papers by this authorE. Lombardini
Istituto di Ricerche Biomediche ‘Antoine Marxer’ RBM S.p.A., Colleretto Giacosa (TO), Italy
Search for more papers by this authorG. Malanca
CTI Cell Therapeutics Europe S.r.l., Bresso (MI), Italy
Search for more papers by this authorF. Motta
CTI Cell Therapeutics Europe S.r.l., Bresso (MI), Italy
Search for more papers by this authorV. Sforza
Quality Management Associates s.a.s., Anzio (RM), Italy
Search for more papers by this authorCorresponding Author
M. M. Brunetti
RTC, Research Toxicology Centre SpA, Pomezia (RM), Italy
Head of QAU, RTC, Research Toxicology Centre SpA, Via Tito Speri 12, 00040 Pomezia (RM), ItalySearch for more papers by this authorM. Astolfi
RTC, Research Toxicology Centre SpA, Pomezia (RM), Italy
Search for more papers by this authorE. Corbascio
CTI Cell Therapeutics Europe S.r.l., Bresso (MI), Italy
Search for more papers by this authorM. Filippone
ACRAF SpA Angelini Group's Company, S. Palomba, Pomezia (RM), Italy
Search for more papers by this authorE. Invernizzi
Istituto di Ricerche Biomediche ‘Antoine Marxer’ RBM S.p.A., Colleretto Giacosa (TO), Italy
Search for more papers by this authorR. Lasala
Istituto di Ricerche Biomediche ‘Antoine Marxer’ RBM S.p.A., Colleretto Giacosa (TO), Italy
Search for more papers by this authorE. Lombardini
Istituto di Ricerche Biomediche ‘Antoine Marxer’ RBM S.p.A., Colleretto Giacosa (TO), Italy
Search for more papers by this authorG. Malanca
CTI Cell Therapeutics Europe S.r.l., Bresso (MI), Italy
Search for more papers by this authorF. Motta
CTI Cell Therapeutics Europe S.r.l., Bresso (MI), Italy
Search for more papers by this authorV. Sforza
Quality Management Associates s.a.s., Anzio (RM), Italy
Search for more papers by this authorThe opinion expressed are those of the authors and do not necessarily reflect the position of the respective monitoring authorities or companies.
Abstract
Archiving of documents and specimens generated during a non-clinical laboratory study is a basic Good Laboratory Practice (GLP) requirement. The records and materials that should be archived as well as the characteristics and the organisation of archive facilities are addressed in the OECD Series on Principles of Good Laboratory Practice No. 1 (OECD Principles of Good Laboratory Practice (as revised in 1997) [1]. However, in recent years, questions concerning archiving have been raised and the need for a more detailed guidance on this matter has become evident
The aim of the Society for Applied Pharmacological Sciences/Italian Group of Quality Assurance in Research (SSFA/GIQAR) working group on ‘Archiving according to GLP’ was to issue a position paper, present it for discussion in an ad hoc round table with representatives of the Italian GLP monitoring authority to promote common standards and to provide additional recommendations on storage and retention of records. Copyright © 2005 John Wiley & Sons, Ltd.
REFERENCES
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