Emphasis On Quality
Biovet produces products that exceed customer expectations in terms of quality and reliability. High levels of product quality are achieved by using only quality raw materials, coupled with the experience of our specialists who use our state-of-the-art equipment. All our manufactured products meet global pharmacopoeial standards.
Biovet validates all production processes, equipment, cleaning procedures, and methods for the analysis of raw materials. Checks are carried out during the production process and on finished products to ensure consistent quality, efficiency and safety throughout.
Quality control checks are performed with the most modern instruments and equipment, including HPLC, GC, IR and NIR, UV / VIS systems and atomic absorption photospectrometers.
Biovet strives to offer not only high quality through its products, but also a high quality of service.
ISO 9001: 2000 / ISO 14001: 2004 Certification
Our quality management system was certified according to ISO 9001: 1994 by TUV Rheinland Euroqua in 1999. In 2003 we implemented an integrated quality management system and environmental protection ISO 9001: 2000 / ISO 14001: 2004. We are certified by SGS United Kingdom, Ltd. Our company is the first pharmaceutical company in Bulgaria to implement and apply this quality system.
- Identification and traceability of critical quality parameters is ensured.
- Strict control is exercised by the quality control department on all input materials, critical parameters during production of intermediate, and final products depending on specifications.
- Raw materials are stored in different warehouses, according to storage requirements.
- Controlling the process parameters to ensure the quality of the product.
- Written procedures are in place for production, control, calibration, maintenance, and testing.
- We carry out GMP-, ISO- and HACCP-targeted training programs to ensure staff competence and awareness.
Good Manufacturing Practice (GMP)
Biovet is a licensed producer of raw materials and finished products. Our production methods meet the requirements of Good Manufacturing Practice (GMP) and Good Laboratory Practice (GLP) from the National Veterinary Service at the Ministry of Agriculture and Forestry. In connection with the accession of Bulgaria to the European Union, all Bulgarian regulatory standards, including the rules for GMP and GLP, are in line with those in the EU.
The main activities related to GMP rules are:
- To ensure constant production and control of the appropriate quality standards.
- To carry out approved production stages and processes according to the approved standard operating procedures and manuals.
- To create records of the production process and store information for each batch.
- To store raw materials, fillers, and intermediates under appropriate conditions - temperature, humidity, etc.
- To carry out strict quality control of all incoming raw materials, critical parameters during production, intermediate products and finished dosage forms in accordance with the established specifications.
Highly qualified staff in the laboratories perform analytical and microbiological analyses according to GLP requirements. Biovet successfully passed the inspection by the Food and Drug Administration (FDA), the regulatory body that controls food and medicine in the United States. We have already submitted dossiers for six products to the FDA Center for Veterinary Medicine:
- tylosin tartrate (powder)
- tylosin tartrate (granule)
- tylosin phosphate (powder)
- tylosin base
- thiamulin hydrogen fumarate
- flavophospholipol
We actively cooperate with US partners and clients for the development of abbreviated new animal drug applications (ANADAs).
