The Netherlands

The Netherlands
Inspected Domestic Test Facilities
Status 1 July 2014
Report issued 28 July 2014
Health Care Inspectorate
TEST FACILITY
DATE OF INSPECTION
STATUS
NATURE OF INSPECTION
AREA OF EXPERTISE
REMARKS
Agrevo Nederland BV
Oosterweg 127
NL-9750 AC Haren
06.1997
09.1997
PEN
IC
RFP
FULL
RE-I
6: field phase
6: field phase
new name since 01.2000
Aventis CropScience
Benelux BV, Oosterhout
AgriChem BV
Koopvaardijweg 9, PO Box 295,
NL-4900 AG Oosterhout
12.2009
03.2012
IC
IC
FULL
FULL
1
1
former name until 11.2007
Brabant Chemie BV
Agro Research International BV
Koeleweg 5
NL-8096 RL Oldebroek
11.2002
02.2006
02.2009
01.2012
01.2014
IC
IC
IC
IC
IC
FULL
FULL
FULL
FULL
FULL
6: field phase
6: field phase
6: field phase
6: field phase
6: field phase
Former address until
01.2013: Kladde 24,
NL-4664 TC Lepelstraat
Akzo Nobel Central Research (ACR),
Ecotoxicology Laboratory
Velperweg 76, PO Box 9300
NL-6800 SB Arnhem
12.1988
10.1989
06.1991
06.1993
07.1995
02.1998
PEN
IC
IC
IC
IC
IC
RFP
FULL
FULL
FULL
FULL
FULL
FULL
4,5
4,5
4,5
4,5
4, 5
1, 4, 5
new name since 02.2002
Akzo Nobel Chemicals
BV, Environm. Chem. &
Regulatory Affairs Dept.
Akzo Nobel Chemicals BV, Environmental
Chemistry & Regulatory Affairs Dept.
Velperweg 76, PO Box 9300
NL-6800 SB Arnhem
02.2002
01.2005
09.2005
IC
PEN
IC
RFP
FULL
FULL
RE-I
1,4,5
1,4,5
1,4,5
former name until 02.2002
Akzo Nobel Centr Res
Ecotox Lab;
new name since 04.2006
Akzo Nobel Technology &
Engineering BV
1
TEST FACILITY
DATE OF INSPECTION
STATUS
NATURE OF INSPECTION
AREA OF EXPERTISE
REMARKS
Akzo Nobel Technology & Engineering BV
Environmental Chemistry Department
Velperweg 76.NL-6824 BM Arnhem
01.2008
02.2010
IC
IC
RFP
FULL
FULL
1,4,5
1,4,5
former name until 04.2006
Akzo Nobel Chemicals;
new name since 08.2012
Akzo Nobel NV, Health,
Safety & Env., Env.
Chemistry
Akzo Nobel NV, Health, Safety and Environment
Department, Environmental Chermistry
Velperweg 76.NL-6824 BM Arnhem
08.2012
IC
FULL
1,4,5
former name until 08.2012
Akzo Nobel Technology &
Engineering BV
Alterra BV, Center for Water & Climate,
Droevendaalsesteeg 3, PO Box 47,
NL-6700 AA Wageningen
12.2002
12.2003
09.2005
02.2008
12.2008
02.2011
11.2011
11.2013
PEN
IC
IC
PEN
IC
PEN
IC
IC
FULL
RE-I
FULL
FULL
RE-I
FULL
RE-I
FULL
4,5
4,5
4,5,7
4,5,7
4,5,7
4,5,7
4,5,7
4,5,7
Ambrosiushoeve Research Centre
Ambrosiusweg 1
NL-5081 NV Hilvarenbeek
02.2000
12.2000
PEN
NIC
RFP
FULL
RE-I
4: bees, bumblebees
4: bees, bumblebees
new name since 01.2001
Applied Plant Research,
Research Unit Apiculture
Analytico Medinet BV
Bergschot 71, PO Box 5510
NL-4800 CD Breda
08.2000
02.2004
03.2006
IC
IC
PEN
RFP
FULL
FULL
FULL
8
8
8
former name until 03.1999
BCO Centre for Research;
new name since 11.2006
Eurofins Medinet BV
Analytisch Biochemisch Lab. BV (ABL)
W.A. Scholtenweg 7, PO Box 232
NL-9400 AE Assen
02.1992
04.1992
11.1995
09.1998
07.2001
12.2001
09.2004
11.2006
09.2009
03.2012
04.2014
PEN
IC
IC
IC
PEN
IC
IC
IC
IC
IC
IC
FULL
RE-I
FULL
FULL
FULL
RE-I
FULL
FULL
FULL
FULL
FULL
8
8
8
8
8
8
8
8
8
8
8
2
TEST FACILITY
DATE OF INSPECTION
STATUS
NATURE OF INSPECTION
Applied Plant Research BV, Bee Research Unit,
Droevendaalsesteeg 1
NL-6700 AB Wageningen
08.2002
11.2005
IC
IC
RFP
FULL
FULL
Aquasense Lab BV
Kruislaan 411A
NL-1090 HC Amsterdam
06.1998
11.1998
PEN
IC
RFP
FULL
RE-I
4,5
4,5
left programme 12.2000
Astellas Pharma Europe BV
Sylviusweg 62
NL-2333 BE Leiden
08.2006
09.2008
12.2010
02.2013
IC
IC
IC
IC
FULL
FULL
FULL
FULL
8
8
8
8
former name until 08.2005
Yamanouchi Europe BV;
former address until 11.12:
Elisabethhof 1, Leiderdorp
Aventis Cropscience Benelux BV
Logistiekweg 18
NL-4900 AC Oosterhout
12.2001
IC
RFP
FULL
6: field phase
former name until 01.2000
AgrEvo Nederland, Haren;
left programme 06.2003
Bactimm BV
Middenkampweg 19
NL-6545 CH Nijmegen
09.2002
08.2003
02.2006
06.2009
11.2011
PEN
IC
IC
IC
IC
RFP
FULL
RE-I
FULL
FULL
FULL
9: validation of microbial
and endotoxine tests
9: validation of microbial
and endotoxine tests
9: validation of microbial
and endotoxine tests
left programme 01.2014
Bayer CropScience SA-NV
Energieweg 1
3641 RT Mijdrecht
02.2014
IC
FULL
6: field phase
BCO Centre for Research,
Bergschot 71
NL-4800 CD Breda
06.1988
11.1988
02.1991
05.1991
06.1993
10.1993
10.1996
PEN
IC
PEN
IC
PEN
IC
IC
RFP
FULL
RE-I
FULL
RE-I
FULL
RE-I
FULL
8
8
1,8
1,8
1,8
1,8
1,8
new name since 03.1999
Analytico Medinet BV
Biomedical Primate Research Centre (BPRC)
Lange Kleiweg 139
NL-2280 GH Rijswijk
04.1998
02.1999
PEN
IC
RFP
2
2
left programme 07.2002
FULL
RE-I
AREA OF EXPERTISE
REMARKS
4: bees, bumblebees former name until 01.2001
4: bees, bumblebees Ambrosiushoeve Res. Cntr;
former address until 10.04
5081 NV Hilvarenbeek;
left programme 01.2011
3
TEST FACILITY
DATE OF INSPECTION
STATUS
NATURE OF INSPECTION
AREA OF EXPERTISE
REMARKS
Bioscan BV,
Prof. Bronkhorstlaan 10-H
NL-3723 MB Bilthoven
04.1996
09.1996
03.2000
04.2003
09.2003
04.2004
PEN
IC
IC
NIC
PEN
IC
RFP
FULL
RE-I
FULL
FULL
FULL
RE-I
9: biocompatibility
medical devices
9: biocompatibility
medical devices
9: biocompatibility
medical devices
left programme 11.2004
Brabant Chemie BV
Koopvaardijweg 9, PO Box 295,
NL-4900 AG Oosterhout
11.1997
06.1998
10.2000
06.2003
05.2005
10.2007
PEN
IC
IC
IC
IC
IC
RFP
FULL
RE-I
FULL
FULL
FULL
FULL
1
1
1
1
1
1
new name since 11.2007:
AgriChem BV
Central Laboratory Animal Institute
Bolognalaan 50, PO Box 80190
NL-3508 TD Utrecht
12.2000
03.2002
04.2005
NIC
IC
PEN
RFP
FULL
FULL
FULL
2
2
2
left programme 07.2006
Central Veterinary Institute, Animal Sciences
Group, Edelhertweg 15, NL-8219 PH Lelystad
05.2008
IC
RFP
FULL
6, 9: Safety studies
former name until 01.2008
ID-Lelystad BV;
left programme 10.2011
Cerexagri BV
Tankhoofd 10, PO Box 6030,
NL-3196 XH Vondelingenplaat/Rotterdam
06.2003
10.2005
09.2007
11.2009
04.2012
06.2014
IC
IC
IC
IC
IC
IC
FULL
FULL
FULL
FULL
FULL
FULL
1
1
1
1
1
1
former name until 02.2001
Elf Atochem Agri BV
Crovin BV
Mechelaarstraat 3
NL-4903 RE Oosterhout
02.2002
NIC
RFP
FULL
6, 9: toxicokinetics
former name until 01.2000
R&W Bio Research;
left programme 11.2002
Crucell Holland BV
Archimedesweg 4-6
NL-2333CN Leiden
06.2008
09.2010
04.2013
IC
IC
IC
FULL
FULL
FULL
8
8
8
Cyanamid Agro Nederland
Druivenstraat 1, PO Box 3607 NL-4800 DP Breda
12.1997
IC
RFP
FULL
6: field phase
left program 03.2001
4
TEST FACILITY
DATE OF INSPECTION
STATUS
NATURE OF INSPECTION
AREA OF EXPERTISE
Dannalabs BV
Wethouder Beversstraat 185
NL-7543 BK Enschede
05.2011
07.2011
10.2013
PEN
IC
PEN
FULL
RE-I
FULL
1: X-ray characterisation
1: X-ray characterisation
1: X-ray characterisation
De Bredelaar BV
Research Company for Plant Protection
Breedlersestraat 7
NL-6662 NP Elst
02.1995
11.1997
12.2001
10.2004
11.2006
12.2009
04.2012
IC
IC
IC
IC
IC
IC
IC
FULL
FULL
FULL
FULL
FULL
FULL
FULL
6: field phase
6: field phase
6: field phase
6: field phase
6: field phase
6: field phase
6: field phase
Dopharma Research BV
Zalmweg 24, PO Box 205
NL-4940 AE Raamsdonkveer
03.1996
10.1996
12.1999
03.2002
02.2005
09.2007
01.2010
05.2012
PEN
IC
IC
IC
IC
IC
IC
IC
FULL
RE-I
FULL
FULL
FULL
FULL
FULL
FULL
2,6,8,9: pharmacokinetics
2,6,8,9: pharmacokinetics
2,6,8,9: pharmacokinetics
2,6,8,9: pharmacokinetics
2,6,8,9: pharmacokinetics
2,6,8,9: pharmacokinetics
2,6,8,9: pharmacokinetics
2,6,8,9: pharmacokinetics
Dow Benelux BV Product Safety Labs
H.H. Dowweg 5, PO Box 48
NL-4530 AA Terneuzen
12.1993
03.1997
IC
IC
RFP
FULL
FULL
1,8
8
left programme 07.1997
DSM Food Specialties R&D, Analysis Dept.
A. Fleminglaan 1
NL-2600 MA Delft
11.2003
IC
RFP
FULL
8
former name until 11.2003
DSM Research, Dept
Analysis for Life Sciences;
left programme 07.2005
DSM Research, Dept Analysis for Life Sciences
A. Fleminglaan 1
NL-2600 MA Delft
04.2000
11.2000
PEN
IC
RFP
FULL
RE-I
8
8
new name since 11.2003
DSM Food Specialties
R&D, Analysis Dept
IC
IC
RFP
FULL
FULL
2,3
2,3
new name since 04.1994
Solvay Duphar BV
IC
IC
RFP
FULL
FULL
1
1
new name since 02.2001
Cerexagri BV
Duphar, Toxicology Department
C.J. van Houtenlaan 36, PO Box 900
NL-1380 DA Weesp
Elf Atochem Agri BV
Tankhoofd 10, PO Box 6030,
NL-3196 XH Vondelingenplaat/Rt
10.1988
06.1991
09.1997
05.2000
REMARKS
5
TEST FACILITY
DATE OF INSPECTION
STATUS
NATURE OF INSPECTION
AREA OF EXPERTISE
REMARKS
Erasmus Medical Center, Dept of Medical
Oncology, Groene Hilledijk 301
NL-3075 EA Rotterdam
04.2006
10.2008
11.2010
IC
IC
IC
RFP
FULL
FULL
FULL
8
8
8
left programme 03.2012
Eurofins Medinet BV
Bergschot 71
NL-4817 PA Breda
11.2006
02.2008
05.2010
09.2012
IC
IC
IC
IC
RE-I
FULL
FULL
FULL
8
8
8
8
former name until 11.2006
Analytico Medinet BV
Farma Research BV
Adelbertusplein 1, PO Box 9101 (164)
NL-5370 AA Nijmegen
12.1992
03.1993
12.1994
10.1997
06.1998
09.2001
09.2004
05.2005
PEN
IC
IC
PEN
IC
IC
PEN
IC
RFP
FULL
RE-I
FULL
FULL
RE-I
FULL
FULL
RE-I
6,8,9: pharmacokinetics
6,8,9: pharmacokinetics
6,8,9: pharmacokinetics
6,8,9: pharmacokinetics
6,8,9: pharmacokinetics
6,8,9: pharmacokinetics
6,8,9: pharmacokinetics
6,8,9: pharmacokinetics
new name since 09.2005
Farma Research Animal
Health
Farma Research Animal Health
Toernooiveld 300-H
NL-6525 EC Nijmegen
06.2007
02.2008
06.2010
12.2012
PEN
IC
IC
IC
FULL
RE-I
FULL
FULL
6,9: pharmacokinetics,
tolerance, bioequivalence
6,9: pharmacokinetics,
tolerance, bioequivalence
former name until 09.2005
Farma Research BV
Fort Dodge Animal Health Holland
CJ van Houtenlaan 36, PO Box 36
NL-1380 DA Weesp
08.1997
11.2001
06.2002
IC
PEN
IC
RFP
FULL
FULL
RE-I
2, 9: pharmacokinetics
safety studies on vaccines
2, 9: pharmacokinetics
safety studies on vaccines
left programme 06.2003
Gist Brocades, Toxicology Lab
Wateringseweg 1
NL-2600 MA Delft
05.1988
02.1990
PEN
PEN
RFP
FULL
FULL
2
2
left programme 06.1991
Global Pathology Support
Benoordenhoutseweg 23
NL-2596 BA Den Haag
09.2005
04.2008
08.2010
08.2012
IC
IC
IC
IC
FULL
FULL
FULL
FULL
2: Pathology
2: Pathology
2: Pathology
2: Pathology
Haemoprobe BV
L.J. Zielstraweg 1, NL-9713 GX Groningen
09.2003
NIC
RFP
FULL
9: biocompatibility
medical devices
left programme 01.2004
6
TEST FACILITY
DATE OF INSPECTION
STATUS
NATURE OF INSPECTION
AREA OF EXPERTISE
REMARKS
Hazleton Biotechnologies
Landjuweel 11, PO Box 454
NL-3900 AL Veenendaal
03.1987
IC
RFP
FULL
3
left programme 01.1989
ID-DLO, Experimental Animal Services Dept
Edelhertweg 15
NL-8200 AB Lelystad
12.1998
PEN
RFP
FULL
6, 9: pharmacokinetics
new name since 01.2000
ID-Lelystad BV
ID-Lelystad BV
Edelhertweg 15
NL-8200 AB Lelystad
04.2000
10.2002
12.2004
09.2006
IC
NIC
NIC
IC
RFP
FULL
FULL
FULL
FULL
6,9: pharmacokinetics
former name until 01.2000
ID-DLO;
new name since 01.2008
Central Veterinary Institute
InSight Pathology
Chopinlaan 6
5343 EM Oss
10.2012
IC
FULL
2: pathology
Intervet International BV
W. de Körverweg 35
NL-5831Boxmeer
02.1995
06.1997
06.2000
10.2003
12.2005
IC
IC
IC
IC
IC
RFP
FULL
FULL
FULL
FULL
FULL
2,6,8,9: safety studies
2,6,8,9: safety studies
2,6,8,9: safety studies
2,6,8,9: safety studies
2,6,8,9: safety studies
new name since 11.2007
Intervet Schering Plough
Animal Health
Intervet International BV, MSD Animal Health
W. de Körverweg 35
NL-5831Boxmeer
09.2012
IC
FULL
2,6,8,9: safety studies
former name until 06.2011
Intervet Schering Plough
Animal Health
Intervet Schering Plough Animal Health
W. de Körverweg 35
NL-5831Boxmeer
04.2008
09.2010
IC
IC
RFP
FULL
FULL
2,6,8,9: safety studies
2,6,8,9: safety studies
former name until 11.2007
Intervet International BV;
new name since 06.2011
Intervet International, MSD
Animal Health
Isotis NV, Prof. Bronkhorstlaan 10-D, PO Box 98
NL-3723 MB Bilthoven
03.2001
IC
RFP
FULL
9: preclinical studies
left programme 07.2003
IVR, Institute Veterinarian Research,
Vollenhofseweg 3, NL-8091 PH Wezep
09.1996
NIC
RFP
FULL
2,6
left programme 01.1997
6,9: safety studies
7
TEST FACILITY
DATE OF INSPECTION
STATUS
NATURE OF INSPECTION
AREA OF EXPERTISE
REMARKS
KCL BioAnalysis BV
Borniastraat 34
NL-8901 BR Leeuwarden
02.2004
IC
RFP
FULL
8
former name until 05.2001
KCL, Stichting Klinisch
Chemisch Laboratorium;
left program 07.2006
KCL, Stichting Klinisch Chemisch Lab
Borniastraat 34
NL-8901 BR Leeuwarden
02.1997
02.2001
IC
IC
RFP
FULL
FULL
8
8
new name since 05.2001
KCL BioAnalysis BV
Kinesis Pharma BV
Lage Mosten 29
NL-4822 NK Breda
11.2003
02.2006
05.2009
08.2011
08.2013
IC
IC
IC
IC
IC
FULL
FULL
FULL
FULL
FULL
9: pharmaco- & toxicokinetic data analyses
9: pharmaco- & toxicokinetic data analyses
Medinet VOF, Central Office / RTC Breda BV
Bergschot 69
NL-4800 CC Breda
09.1994
12.1995
IC
IC
RFP
FULL
RE-I
8
8
new name since 09.1998
Medinet VOF / CRL (clin.
ref. lab.)
Medinet VOF, CRL (Clinical Reference
Laboratory), Bergschot 69
NL-4800 CC Breda
09.1998
NIC
RFP
FULL
8
former name until 09.1998
Medinet VOF / RTC;
left programme 01.1999
Merck Millipore,
MicroSafe BioSafety Solutions Laboratory
Darwinweg 24, NL-2333 CR Leiden
09.2010
IC
RFP
FULL
9: tests for microbial
contamination and
identification
former name until 09.2010
Microsafe Serv. Millipore;
new name since 03.2012
MicroSafe Labs
Microsafe Laboratories
Darwinweg 24
NL-2333 CR Leiden
10.2012
07.2013
PEN
IC
FULL
RE-I
9: tests for microbial
contamination and
identification
former name until 03.2012
Merck Millipore Microsafe
BioSafety Solutions Lab
Microsafe BV
N. Bohrweg 11-13
NL-2333 CA Leiden
05.1994
05.1997
11.2000
06.2001
04.2004
IC
IC
PEN
IC
IC
RFP
FULL
FULL
FULL
RE-I
FULL
9: tests for microbial
contamination and
identification
new name since 07.2005
MicroSafe Services from
Millipore
8
TEST FACILITY
DATE OF INSPECTION
STATUS
NATURE OF INSPECTION
AREA OF EXPERTISE
REMARKS
MicroSafe Services from Millipore
Darwinweg 24
NL-2333 CR Leiden
12.2007
09.2008
PEN
IC
RFP
FULL
RE-I
9: tests for microbial
contamination and
identification
Mitox Consultants
Science Park 408, PO Box 92260,
NL-1090 AG Amsterdam
07.1996
01.1997
03.2000
03.2003
02.2006
04.2009
02.2012
05.2014
PEN
IC
IC
IC
IC
IC
IC
IC
FULL
RE-I
FULL
FULL
FULL
FULL
FULL
FULL
4: arthropods
4: arthropods
4: arthropods
4: arthropods
4: arthropods
4: arthropods
4: arthropods
4: arthropods
MSD, NV Organon, Bioanalytics Department
Molenstraat 110, PO Box 20
NL-5340 BH Oss
06.2010
IC
RFP
FULL
8
former name until 06.2010
Organon NV, Bioanalytics
left programme 12.2011
MSD, NV Organon, Toxicology & Drug
Disposition Department
Nistelrooisebaan 3, NL-5374 RE Schaijk
06.2010
IC
RFP
FULL
2,3,8,9: toxicokinetics
former name 06.2010:
Organon NV, Toxicology
& Drug Disposition Dept.;
left programme 12.2011
Nobilon International BV, Wim de Körverstraat 35
5831 AN Boxmeer
04.2009
IC
RFP
FULL
2
left programme 11.2010
Notox C.V., Hambakenwetering 31,
NL-5231 BD ‘s-Hertogenbosch
04.1987
IC
RFP
FULL
2,3,4
new name since 02.1988
RCC Notox
Notox BV
Hambakenwetering 7
NL-5231 DD ‘s Hertogenbosch
11.1993
10.1996
10.1999
05.2002
02.2005
04.2007
02.2009
03.2011
IC
IC
IC
IC
IC
IC
IC
IC
RFP
FULL
FULL
FULL
FULL
FULL
FULL
FULL
FULL
1,2,3,4,5,8
1,2,3,4,5,8
1,2,3,4,5,8
1,2,3,4,5,6,8,9: kinetics;
metabolism
former name until 11.1993
RCC Notox Research &
Consulting Company BV;
new name since 05.2012
WIL Research Europe BV
former name until 07.2005
Microsafe BV;
new name since 09.2010:
Merck Millipore Microsafe
BioSafety Solutions Lab
1,2,3,4,5,6,8,9: kinetics;
metabolism; safety
pharmacology
9
TEST FACILITY
DATE OF INSPECTION
STATUS
NATURE OF INSPECTION
AREA OF EXPERTISE
REMARKS
Organon International BV
Preclinical Development Laboratories
Molenstraat 110, PO Box 20
NL-5340 BH Oss
11.1987
03.1990
09.1990
11.1992
02.1996
IC
PEN
IC
IC
IC
RFP
FULL
FULL
RE-I
FULL
FULL
2,3,8
2,3,8
2,3,8
2,3,8
2,3,8
new name since 07.1999
Organon NV, Depts Drug
Metabolism & Kinetics,
Toxicology & Drug
Disposition
Organon NV, Bioanalytics Department
Molenstraat 110, PO Box 20
NL-5340 BH Oss
10.2007
IC
RFP
FULL
8
former name until 04.2007
Organon NV, Clinical
Pharmacol. & Kinetics;
new name since 06.2010:
MSD Organon,
Bioanalytics Department
Organon NV
Clinical Pharmacology & Kinetics Department
Molenstraat 110, PO Box 20
NL-5340 BH Oss
06.2005
IC
RFP
FULL
8
former name until 06.2005
Organon, Drug Metabolism
& Kinetics;
new name since 04.2007
Organon NV, Department
of Bioanalytics
Organon NV
Drug Metabolism & Kinetics Department
Molenstraat 110, PO Box 20
NL-5340 BH Oss
07.1999
07.2002
IC
IC
RFP
FULL
FULL
8
8
former name until 07.1999
Organon Intern., Preclin.
Dev. Labs;
new name since 06.2005
Clinical Pharmac.& Kin.
Organon NV,
Toxicology & Drug Disposition Department
Nistelrooisebaan 3
NL-5374 RE Schaijk
07.1999
06.2002
06.2005
10.2007
IC
IC
IC
IC
RFP
FULL
FULL
FULL
FULL
2,3
2,3
2,3,9: toxicokinetics
2,3,8,9: toxicokinetics
former name until 07.1999
Organon Intern., Preclin.
Dev. Labs;
new name since 06.2010:
MSD Organon,,
Toxicology&Drug Dispos.
Pharma BioResearch Group BV
Stationsweg 163, PO Box 200
NL-9470 AE Zuidlaren
09.2000
04.2001
05.2004
04.2005
PEN
IC
PEN
IC
RFP
FULL
RE-I
FULL
RE-I
8
8
8
8
former name until 07.1999
Pharma BioResearch Int.;
new name since 07.2006
PRA Int. , Early Dev. Serv.
10
TEST FACILITY
DATE OF INSPECTION
STATUS
NATURE OF INSPECTION
AREA OF EXPERTISE
REMARKS
Pharma BioResearch International BV
Stationsweg 163, PO Box 200
NL-9470 AE Zuidlaren
10.1993
09.1996
IC
IC
RFP
FULL
FULL
8
8
new name since 07.1999
Pharma BioResearch
Group BV
PRA International, Early Development Services
Westerbrink 3
NL-9405 BJ Assen
12.2007
09.2010
11.2012
IC
IC
IC
FULL
FULL
FULL
8
8
8
former name until 07.2006
Pharma BioResearch
Group
Proeftuin Zwaagdijk
Tolweg 13
NL-1681 ND Zwaagdijk-Oost
03.2004
11.2004
04.2006
10.2009
01.2012
PEN
IC
IC
IC
IC
FULL
RE-I
FULL
FULL
FULL
6: field phase
6: field phase
6: field phase
6: field phase
6: field phase
Proxy Laboratories BV
Archimedesweg 25
NL-2333 CM Leiden
04.2005
12.2005
06.2008
01.2011
11.2011
10.2013
NIC
IC
IC
PEN
IC
IC
FULL
FULL
FULL
FULL
RE_I
FULL
8
8
8
8
8
QPS Netherlands BV
Petrus Campersingel 123
NL-9713 AG Groningen
02.2011
01.2013
IC
IC
FULL
FULL
8
8
previous name until
09.2010 Xendo Drug
Development BV
RCC Notox Research & Consulting Company BV,
Hambakenwetering 7
NL-5231 DD ‘s Hertogenbosch
03.1989
11.1989
11.1991
PEN
IC
IC
RFP
FULL
RE-I
FULL
1,2,3,4
1,2,3,4
1,2,3,4
former name until 02.1988
Notox C.V;.
new name since 11.1993
Notox BV
Redened BV
Panhuysstraat 6, PO Box 24009
NL-6363 ZG Wijnandsrade
04.1995
11.1995
09.1999
01.2003
01.2004
05.2007
PEN
IC
IC
PEN
IC
IC
RFP
FULL
RE-I
FULL
FULL
RE-I
FULL
6: field phase
6: field phase
6: field phase
6: field phase
6: field phase
6: field phase
left programme 01.2009
Reinier de Graaf Diagnostisch Center SSDZ
R de Graafweg 3-11, NL-2600 GA Delft
03.1999
NIC
RFP
FULL
9: virus removal
left programme 04.2003
11
TEST FACILITY
DATE OF INSPECTION
STATUS
NATURE OF INSPECTION
AREA OF EXPERTISE
REMARKS
Rephartox BV, Zuidersluisweg 2
NL-8243 RC Lelystad
11.2006
PEN
RFP
FULL
8
left programme 10.2007
Rhône-Poulenc Agro BV
Zeedijk 47, PO Box 209
NL-4870 AE Etten-Leur
06.1995
11.1997
IC
IC
RFP
FULL
FULL
6: field phase
6: field phase
new name since 01.2000
Aventis CropScience
Benelux BV
Rikilt Institute of Food Safety
Bornsesteeg 45, PO Box 230,
NL-6700 AE Wageningen
01.1998
03.2001
02.2002
04.2005
12.2005
IC
PEN
IC
PEN
IC
RFP
RE-I
FULL
RE-I
FULL
RE-I
6,8
6,8,9: kinetics
6,8,9: kinetics
6,8
6,8
left programme 11.2006
RIVM-ARO, Residue analysis Laboratory
Antonie van Leeuwenhoeklaan 9, Postbus 1
NL-3720 Bilthoven
02.1994
12.1994
01.1998
07.2001
PEN
IC
IC
PEN
RFP
FULL
RE-I
FULL
FULL
8
8
8
8
left programme 08.2002
RIVM-BFT, Unit Biotransformation, Farmaco- &
Toxicokinetics, A.van Leeuwenhoeklaan 9,
PO.Box 1, NL-3720 BA Bilthoven
06.1992
12.1993
NIC
IC
RFP
FULL
FULL
2,3
2,3
left programme 01.1999
RIVM-BKG, Quality Assurance Bureau
NL-3720 BA Bilthoven
06.1992
01.1996
NIC
RFP
9: quality assurance
left programme 01.1996
RIVM-CDL, Central Animal Laboratory
Antonie van Leeuwenhoeklaan 9, Postbus 1
NL-3720 BA Bilthoven
12.1993
08.1996
02.2000
IC
IC
IC
RFP
FACI
FACI
FACI
2: animal husbandry
2: animal husbandry
2: animal husbandry
left programme 03.2002
RIVM-ECO, Ecotoxicology Laboratory
NL-3720 BA Bilthoven
09.1993
02.1995
PEN
PEN
RFP
FULL
FULL
4,5
4,5
left programme 11.1995
RIVM-LBG, Laboratory for Soil & Ground-water
Research, NL-3720 BA Bilthoven
01.1998
PEN
RFP
FULL
6: field phase
left programme 09.1999
RIVM-LCM, Carcino-and Mutagenesis Lab.
Antonie van Leeuwenhoeklaan 9, Postbus 1
NL-3720 BA Bilthoven
06.1992
01.1995
NIC
IC
RFP
FULL
FULL
2,3
2,3
left programme 02.1996
12
TEST FACILITY
DATE OF INSPECTION
STATUS
NATURE OF INSPECTION
AREA OF EXPERTISE
REMARKS
RIVM-LPI, Laboratory for Pathology &
Immunobiology , Antonie van Leeuwenhoeklaan
9, Postbus 1, NL-3720 BA Bilthoven
02.1996
09.1999
IC
IC
RFP
FULL
FULL
2
2
former name until 02.1996
RIVM-PAT;
left programme 03.2002
RIVM-PAT, Laboratory for Pathology
NL-3720 BA Bilthoven
01.1993
IC
RFP
FULL
2
new name since 02.1996
RIVM-LPI
RIVM-TEP, Unit Teratology, Endocrinology &
Perinatal Screening
NL-3720 BA Bilthoven
06.1992
01.1995
NIC
PEN
RFP
FULL
FULL
2,3
2,3
left programme 11.1995
RIVM-TOX, Toxicology Laboratory
NL-3720 BA Bilthoven
06.1992
01.1993
NIC
IC
RFP
FULL
FULL
2
2
left programme 02.1996
R&W Bio Research
Mechelaarstraat 3
NL-4903 RE Oosterhout
09.1995
01.1996
02.1999
PEN
IC
IC
RFP
FULL
RE-I
FULL
8,9: pharmacokinetics
8,9: pharmacokinetics
8,9: pharmacokinetics
new name since 01.2000
Crovin BV
Sanquin, Pharmaceutical Services,
Virus Safety Services Laboratory
Plesmanlaan 125, PO Box 9190,
NL-1006 AD Amsterdam
11.2004
12.2005
11.2007
12.2008
03.2011
02.2013
PEN
IC
PEN
IC
IC
IC
RFP
FULL
RE-I
FULL
RE-I
FULL
FULL
9: validation of virus
removal/inactivation
9: validation of virus
removal/inactivation
9: validation of virus and
prion removal/
inactivation
left programme 09.2013
Slotervaart Hospital, Pharmacy & Pharmacology
Department, Bioanalytical Laboratory
Louwesweg 6, PO Box 90440,
NL-1006 BK Amsterdam
05.1999
02.2002
09.2004
01.2007
09.2009
10.2011
12.2013
IC
IC
IC
IC
IC
IC
IC
FULL
FULL
FULL
FULL
FULL
FULL
FULL
8
8
8
8
8
8
8
New name since 01.2014
Netherlands Cancer
Institute/A. van
Leeuwenhoek, Dept of
Pharmacy & Pharmacology
Bioanalytical Laboratory
Solvay Duphar BV, Departments Drug Safety,
Bio-Analysis, and Environmental Research
NL-1380 DA Weesp
04.1994
02.1997
IC
IC
RFP
FULL
FULL
2,3,4,5,8,9:
pharmacokinetics
former name until 04.1994
Duphar, Toxicology Dept;
new name since 06.2000
Solvay Pharmaceuticals
13
TEST FACILITY
DATE OF INSPECTION
STATUS
NATURE OF INSPECTION
AREA OF EXPERTISE
REMARKS
Solvay Pharmaceuticals BV
C.J. van Houtenlaan 36, PO Box 900
NL-1380 DA Weesp
06.2000
03.2004
06.2006
06.2009
IC
IC
IC
IC
RFP
FULL
FULL
FULL
FULL
1,2,4,8
1,2,4,8
1,2,4,8
1,2,4,8
former name until 06.2000
Solvay Duphar BV;
left programme 06.2011
Syngenta Crop Protection BV,
Stepvelden 8
NL-4700 BA Roosendaal
01.2002
12.2004
IC
IC
RFP
FULL
FULL
6: field phase
6: field phase
former name until 01.2001
Zeneca;
left programme 09.2006
TNO-CIVO
Utrechtseweg 48, PO Box 360
NL-3700 AJ Zeist
06.1987
12.1987
09.1988
02.1989
03.1991
PEN
PEN
PEN
IC
IC
RFP
FULL
RE-I
FULL
RE-I
FULL
2,3
2,3
2,3
2,3
2,3
new name since 02.1993
TNO-ITV
TNO Defence, Security & Safety
Lange Kleiweg 137, PO Box 45
NL-2280 AA Rijswijk
04.2007
10.2009
05.2010
IC
PEN
IC
RFP
FULL
FULL
RE-I
1
1
1
former name until 01.2005
TNO-PML;
new name since 09.2012
TNO Technical Sciences
TNO, Expertise Group Microbiology and Systems
Biology, Utrechtseweg 48, P.O. Box 360,
3700 AJ Zeist
01.2014
IC
FULL
2,9: in vitro studies
TNO Imares BV
Ambachtsweg 8a, PO Box 57
NL-1780 AB Den Helder
02.2007
06.2008
PEN
NIC
RFP
FULL
RE-I
5,7
former name until 01.2007
TNO Inst. Environmental
Scns, Energy Res &Process
Innov, Ecol. Risk Studies;
left programme 01.2011
TNO-IMW, TNO Institute of Environmental
Sciences, Analytical Chemistry Dept.
Schoemakerstraat 97
NL-2628 VK Delft
04.1991
11.1992
10.1994
PEN
IC
IC
RFP
FULL
RE-I
FULL
8
8
8
left programme 04.1996
TNO-IMW, TNO Institute of Environmental
Sciences, Biology Department
Schoemakerstraat 97
NL-2628 VK Delft
04.1991
12.1994
IC
IC
RFP
FULL
FULL
4,5
4,5
former name until 04.1991
TNO-MT, Biology Dept;
new name since 01.1996
TNO Nutrition & Food
Res., Toxicology Division
14
TEST FACILITY
DATE OF INSPECTION
STATUS
NATURE OF INSPECTION
AREA OF EXPERTISE
REMARKS
TNO Institute of Environmental Sciences,
Energy Research and Process Innovation,
Dept. for Ecological Risk Studies, Ambachtsweg
8a, PO Box 57, NL-1780 AB Den Helder
05.2001
03.2004
12.2004
IC
PEN
IC
RFP
FULL
FULL
RE-I
7
5,7
5,7
new name since 01.2007
TNO Imares BV
TNO-ITV
Utrechtseweg 48, PO Box 360
NL-3700 AJ Zeist
02.1993
IC
RFP
FULL
2, 3
former name until 02.1993:
TNO-CIVO;
new name since 06.1995
TNO Nutrition & Food
Res., Toxicology Division
TNO-MT, TNO Institute of Environmental
Sciences, Biology Department, Schoemakerstraat
97, NL-2628 VK Delft
12.1988
IC
RFP
FULL
4
new name since 04.1991
TNO-IMW, Biology Dept.
TNO Nutrition & Food Research
Utrechtseweg 48, PO Box 360
NL-3700 AJ Zeist
10.2001
02.2003
06.2003
06.2004
IC
PEN
IC
IC
RFP
FULL
FULL
RE-I
FULL
2,3,6,8,9: biodegradation,
kinetics, metabolism,
occupational toxicology
2,3,6,8,9: biodegradation,
kinetics, metabolism,
occupational toxicology
former names: TNO
Nutrition & Food Res.:
Analytical Div until 07.99;
Toxicol. Div. until 02.03;
new name since 01.2005
TNO Quality of Life
TNO Nutrition & Food Research
Analytical Sciences Division
Utrechtseweg 48, PO Box 360 NL-3700 AJ Zeist
06.1995
03.1998
IC
IC
RFP
FULL
FULL
8
8
new name since 07.1999
TNO, Nutrition & Food
Research
TNO Nutrition & Food Research,
ILOB Department,
NL-6700 AA Wageningen
05.1999
11.1999
PEN
PEN
RFP
FULL
FULL
2,9: kinetics
2,9: kinetics
left programme 04.2000
TNO Nutrition & Food Research
Toxicology Division
Utrechtseweg 48, PO Box 360, NL-3700 AJ Zeist
05.1996
09.1996
11.1999
PEN
IC
IC
RFP
FULL
RE-I
FULL
2,3,4,5,6,8,9: metabolism,
kinetics
2,3,9: metabolism,
kinetics
former name
until 05.1996 TNO-ITV;
new name since 02.2003
TNO Nutrition &Food Res.
TNO Nutrition & Food Research
Department of Environmental Toxicology
Utrechtseweg 48, PO Box 360
NL-2600 JA Delft
09.2000
IC
RFP
FULL
4,5
former name until 07.1999
TNO, Nutr.&Food Res.,
Toxicology Division;
new name since 02.2003
TNO Nutrition &Food Res.
15
TEST FACILITY
DATE OF INSPECTION
STATUS
NATURE OF INSPECTION
AREA OF EXPERTISE
REMARKS
TNO-PML, Prins Maurits Laboratory
Lange Kleiweg 137, PO Box 45
NL-2280 AA Rijswijk
04.1989
12.1990
11.1992
11.1995
06.1998
10.2001
12.2004
NIC
IC
IC
IC
IC
IC
IC
RFP
FULL
FULL
FULL
FULL
FULL
FULL
FULL
1
1
1
1
1
1,8
1,8
new name since 01.2005
TNO Defence, Security &
Safety
TNO Prevention and Health
Zernikedreef 9, PO Box 2215
NL-2301 CE Leiden
03.1999
06.2002
08.2005
PEN
IC
PEN
RFP
FULL
FULL
FULL
8
8
8
left programme 04.2006
TNO Quality of Life
Utrechtseweg 48, PO Box 360
NL-3700 AJ Zeist
10.2006
IC
FULL
10.2008
IC
RFP
FULL
TNO Research Group Pharmacokinetics & Human
Studies
Utrechtseweg 48, PO Box 360 NL-3700 AJ Zeist
09.2011
IC
RFP
FULL
2,9: kinetics, metabolism,
in-vitro studies
Former name until 01.2011
TNO, Quality of Life
New name since 01.2014:
TNO, Exp. Gr. Microbiol.
& Systems Biology
TNO Technical Sciences
Lange Kleiweg 137, PO Box 45
NL-2280 AA Rijswijk
09.2012
IC
RFP
FULL
1
former name until 09.2012
TNO Defence, Sec.& Saf.;
left programme 2013.07
TNO Triskelion BV
Utrechtseweg 48
3704 HE Zeist
06.2011
05.2013
IC
IC
FULL
FULL
2,3,8,9: safety
pharmacology, worker
exposure and in-vitro
studies
Former name until 01.2011
TNO Quality of Life
2,3,6,8,9: biodegradation, former name until 01.2005
kinetics, metabolism, TNO Nutrition&Food Res.;
new name since 01.2011
worker exposure
2,3,8,9: kinetics and TNO Triskelion BV / TNO
metabolism, safety
Research Group
Pharmacokinetics &
pharmacology, worker
Human Studies
exposure and in-vitro
studies
16
TEST FACILITY
DATE OF INSPECTION
STATUS
NATURE OF INSPECTION
AREA OF EXPERTISE
REMARKS
Unilever Research Laboratory
Olivier van Noortlaan 120, Postbus 114
NL-3130 AC Vlaardingen
05.1989
06.1990
04.1992
12.1995
12.1998
08.1999
PEN
NIC
IC
IC
PEN
IC
RFP
FULL
RE-I
FULL
FULL
FULL
RE-I
2,8
2,8
2,8
2,8
2,8
2,8
left programme 01.2002
Uniroyal Chemical BV
Ankerweg 18, P.O. Box 58217
NL-1040 HE Amsterdam
04.1997
11.1997
02.2001
PEN
IC
IC
RFP
FULL
RE-I
FULL
1
1
1
left programme 04.2004
WIL Research Europe BV
Hambakenwetering 7
NL-5231 DD ‘s Hertogenbosch
03.2013
IC
FULL
1,2,3,4,5,6,8,9: kinetics,
metabolism, safety
pharmacology
former name until 05.2012
Notox BV
Xenobiosis, Free University
De Boelelaan 1083
NL-1081 HV Amsterdam
07.1996
08.1998
IC
IC
RFP
FULL
FULL
8
8
left programme 10.2001
Xendo Laboratories
L.J. Zielstraweg 1, NL-9173 GX Groningen
08.2000
09.2003
IC
IC
RFP
FULL
FULL
8
8
new name since 01.2006
Xendo Drug Development
Xendo Drug Development BV
Hanzeplein 1, NL-9713 GZ Groningen
05.2006
09.2008
IC
IC
RFP
FULL
FULL
8
8
former name until 01.2006
Xendo Laboratories;
new name since 09.2010
QPS Netherlands BV
Yamanouchi Europe BV
Biological Development Department
Elisabethhof 1, NL-2350 AC Leiden
10.2003
08.2004
PEN
IC
RFP
FULL
RE-I
8
8
new name since 08.2005
Astellas Pharma Europe
BV
Zeneca BV, Zeneca Agro Department
Voorn 47
NL-2980 AG Ridderkerk
10.1997
07.1999
PEN
IC
RFP
FULL
RE-I
6: field phase
6: field phase
new name since 01.2001
Syngenta Crop Protection
17
Legends to the abbreviations used:
Areas of expertise of the inspected test facility:
1
Physical-Chemical testing.
2
Toxicity studies.
3
Mutagenicity studies.
4
Environmental toxicity studies on aquatic and terrestrial organism.
5
Studies on behaviour in water, soil and air; bioaccumulation.
6
Residue studies.
7
Studies on effects on mesocosms and natural ecosystems.
8
Analytical and clinical chemistry.
9
Other: specified.
Status of test facilities:
IC
In compliance with GLP.
NIC
Not in compliance: Major deviations from the GLP principles have been observed. Procedures in the test facility are such that the reliability of data cannot be
ensured.
PEN
Pending: GLP compliance status not yet decided on.
RFP
Removed from inspection program.
Nature of Inspection:
FULL
RE-I
Full routine GLP inspection including study audit.
Re-inspection following first or routine GLP inspection.
SA
FACI
Study audit on request of other authorities.
Facility inspection.
18

Download Report