List of holders of GLP Certificate

   

Holders of GLP certificate

List of Test Facilities included in the Czech GLP National Programme.

Updated 11.03.2016

 

Test Facility

Date of inspection first/last

Compliance status

Nature of inspection

Area of expertise

Remarks

ANADIAG SA, CZ organizační složka podniku

Chleny 46

517 45 Chleny

7.2013

ic

full

6

A 1)

9.2014

ic

full

6

A

BIOPHARM

Výzkumný ústav biofarmacie a veterinárních léčiv, a.s.

Pohoří-Chotouň 90,

254 49 Jílové u Prahy

4.1994

1.2003

ic

ic

full

Full

2, 6, 9 *)

S 2)

A

2.2016

ic

re-i

2, 6, 9 *)

S/A, repair of facilities

MediTox s.r.o.

(formely BioTest, s.r.o.)

Pod Zámkem 279,

281 25 Konárovice

12.1999

ic

fac

2, 3, 8

S

11.2015

ic

sa

2, 3, 8

S/A, on request of ECHA

BIOVETA, a.s.

Komenského 212,

683 23 Ivanovice na Hané

2.2005

nic

fac

2, 8, 9 *)

S

3.2013

ic

full

2, 8, 9 *)

S

CEPHA, s.r.o.

Komenského 19,

323 12 Plzeň

1.1998

ic

full

8, 9 *)

S

1.2016

ic

full

8, 9 *)

S

Chemila, spol. s r.o.

Blažkova 5,

695 01 Hodonín

4.2004

pen

fac

9 **)

A

4.2015

ic

re-i

9 **)

A

EMPLA, spol. s r.o.

Za Škodovkou 305,

503 11 Hradec Králové

11.2001

nic

fac

4

A

2.2014

ic

full

4, 5

A

I2L Research Ltd. org. složka

Na Zlaté stoce 1619

370 05 České Budějovice

11.2011

ic

full

9***)

A

7.2015

ic

re-i

9***)

A, change of addres, new facilities

PHARMAKL, s.r.o.

Slovenská 993/9

120 00 Praha 2

9.1995

ic

fac

8, 9 *)

S

4.2015

ic

full

8, 9 *)

S

 

Test Facility

Date of inspection first/last

Compliance status

Nature of inspection

Area of expertise

Remarks

Quinta Analytica, s.r.o.

Pražská 1486/18c

102 00 Praha 10

12.1997

ic

fac

8, 9 *)

S

1.2016

ic

full

8, 9 *)

S

Státní zdravotní ústav

Šrobárova 48

100 42 Praha 10

10.2015

ic

full

1, 2 (in vitro)

A

 

 

 

 

 

Tekro, spol. s r.o.

Provoz Nová Dědina,

783 91 Uničov

2.2014

ic

full

6

S

 

 

 

 

 

Ústav jaderného výzkumu

(formaly Ústav jaderného výzkumu)

Husinec-Řež, č.p. 130

250 68 Řež

8. – 9. 2. 2006

ic

fac

8, 9 *)

S

1.2015

ic

full

8, 9 *)

S

Výzkumný ústav organických syntéz, a.s.

Rybitví č.p. 296

533 54 Rybitví

3./6.1994

ic

fac/sa

2, 3, 8

S

9.2000

ic

full

1–5, 8

A

12.2014

ic

full

1–6, 8

S/A

*) pharmacokinetic studies, effectivity studies

**) microbiological testing of disinfection effectivity

microbiological testing of cosmetic

***) insecticide, biocide and repellent product efficacy testing

 

1) inspected by ASLAB (National GLP Inspection Authority, Centre for Assessment of Laboratories ASLAB, T. G. Masaryk Water Research Institute, public research institution)

2) inspected by SUKL (State Institute for Drug Control)

Glosary 

Area of expertise

  1. Physical-chemical testing
  2. Toxicity studies
  3. Mutagenity studies
  4. Environmental toxicity studies on aquatic and terrestrial organisms
  5. Studies of behaviour in water, soil and air, bioaccumulation
  6. Residue studies
  7. Studies on effects on environment and natural ecosystems
  8. Analytical and clinical chemistry testing
  9. Other studies

Status

- ic (in compliance);

- nic (not in compliance);

- pen (pending, explanation in Remarks field);

- rfp (removed from programme, specify date and reason of removal in Remarks field).

Nature of inspection 

- fac (facility inspection);

- sa (study audit);

- full (fac+sa);

- re-i (re-inspection as follow-up to full inspection).