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Iris Pharma and GLP

Accreditation and inspections

GLP guideline

GLP guideline

OECD "Principles of good laboratory practice regulations" C(97)186, (Official Journal European Communities 1999; 42: L77, 8-21)

http://www.oecd.org/document/63/0,2340,en_2649_34381_2346175_1_1_1_37465,00.html

 

OECD “Series on principles of good laboratory practice and compliance monitoring - Number 1”

OECD Principles on Good Laboratory Practice (ENV/MC/CHEM(98)17)


OECD "Series on principles of good laboratory practice and compliance monitoring - Number 13"

The Application of the OECD Principles of GLP to the Organisation and Management of Multi-Site Studies (ENV/JM/MONO(2002)9)

 

FDA "Good Laboratory Practices (GLP) under 21 CFR 58 applies to nonclinical laboratory studies" :

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=58

 

FDA "Bioanalytical Method Validation" (of May 2001) :

http://www.fda.gov/cder/guidance/4252fnl.pdf

 

FDA "Electronic Records; Electronic Signatures - Scope and Application" (Guidance for Industry - 21 CRF Part 11) :

http://www.fda.gov/cder/guidance/5667fnl.pdf

 

EEC "Harmonisation of laws, regulations and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their applications for tests on chemical substances" (DIRECTIVE 2004/10/EC of the European Parliament and of the Council)
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2004:050:0044:0059:EN:PDF

 

French decision "GLP on chemicals" (Journal Officiel de la République Française n°282, page 18324, texte n° 14) http://www.legifrance.gouv.fr/WAspad/UnTexteDeJorf?numjo=INDI0630099D

 

French decision "GLP on drugs and cosmetics" (Journal Officiel de la République Française 2000; 132: 4465) http://afssaps.sante.fr/htm/3/indbpl.htm

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