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Department of Biological Controls at the Institute of Physiology AS CR provides
comprehensive pharmaceutical services in accordance with the principles of good manufacturing practice (GMP).
Department of Biological controls offers to the business partners the performance of biological
studies for their research and development goals within the GMP regimen and in accordance with the OECD methods:
implementation of customized experiments for external authority
quality control of manufacturing operations of medicinal products for human use
implementation of customized experiments for external authority
toxicological studies and testing of commercially manufactured drugs
pharmacological tests (determination of the efficacy of immunomodulators)
toxicological tests (tests on specific and nonspecific harmlessness)
pharmacopoeial tests (evidence of extraneous agents in viral vaccines and human cell substrate for the manufacture of human vaccines)
testing of vaccines and allergens (methods for determining efficacy and safety)
immunization of animals and blood products formulation
Department of Biological controls is a GMP certified laboratory holding Certificate of GMP
Compliance of a manufacturer issued by the State Institute for Drug Control (SIDC) for
control laboratory (The control laboratory) in the range of biological production for quality control of medicinal
products for human use and investigational medicinal products (Quality Control testing of human medicinal products).
Institute of Physiology AS CR holds Accreditation of user facility for usage of laboratory
animals and Certification of a breeding and supplying facility for breeding of laboratory animals
issued by the Central Commission for protection of animals of the Ministry of Agriculture (CCPA)
Contacts:
Department of Biological controls
Richard Pospisil, MVD, PhD.
Head
Phone/Fax: +420 296 442 280
Email: rpospisil biomed.cas.cz
Ing. Kubečková Michaela
deputy Head
Phone/Fax: +420 296 442 805
Email: fabianovabiomed.cas.cz
Quality Assurance
RNDr. Jiří Marhan, CSc.
QA , Head
Address:
Institute of Physiology AS CR
Vídeňská 1130
Prague 4
142 20
Czech Republic
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