QUALITY ASSURANCE
BioTest strictly adheres to comprehensive quality assurance program covering every aspect of the activities from business negotiations through material supply, personal training, data management and reporting. The facility is regularly inspected by the national authorities, the State Institute for Drug Control (SÚKL) which is the member of OECD Board and NIO ASLAB (Ministry of Environment of the Czech Republic). The last regular inspection took place in August 2009.
BioTest acknowledges FDA standards; today the facility is FDA approvable.
Certification and Approvals
Good Laboratory Practice Certificate acording to the Principles of OECD C(81)30(Final) issued by State Institute for Drug Control (SÚKL) for pharmaceuticals, medical devices, food additives
Good Laboratory Practice Certificate according to the Principles of OECD C(81)30(Final) issued by Ministry of Environment (NIO ASLAB) for chemicals, agrochemicals, REACH
Certificate about authorization and registration of Experimental and Breeding facilities issued in accordance with the provision of § 49 letter h) item 1. of Law No. 166/1999 of Collect. of Laws about veterinary care and about changes in some relevant laws, in the wording of later regulations and § 55, section 2 of public notice of Ministry of Agriculture No. 382/2003 of Collect. of Laws about veterinary requirements posed on trade with animals and about veterinary conditions controlling their import from third countries.
Authorization for Using of Experimental Animals issued by the Central Committee for Animal Protection of the Ministry of Agriculture (ÚKOZ) Reg. No. CZ 217601141
Authorization for Breeding of Experimental Animals issued by the Central Committee for Animal Protection of the Ministry of Agriculture (ÚKOZ) Reg. No. CZ 1760152
Other Certification and Approvals
The company has been incorporated into the List of Users for restricted handling with GMO in compliance with Act No. 153/2000 Collection of Laws.
Official Import Authorization for Psychotropic substance No. PL-D-98/2007 Issued by Ministry of Health of the Czech Republic according to Gazette Law No. 167/1998 Coll.