Biological production

Services

Quality system

Strengthening Veterinarski Zavod Subotica’s position on the domestic and international market guarantees continuous product quality and safety improvements, as well as the enhancement of all its production and business processes. The quality system is integrated in all business segments and all phases of the identified production processes – from product development to control, storage and distribution.

Within the framework of the quality management system, we realize the production of of all our products at the highest possible quality and safety level, by continuously improving the total production performance, thus ensuring compliance with customer expectations and requirements, while adhering to all relevant laws, regulations and international standards.

Since 2000, we have continuously maintained and certified the QMS standard. We are the first veterinary manufacturing company in Serbia certified by a competent authority of an EU member state, i.e. the obtained EU GMP certificate for three production plants (one plant for the production of liquid pharmaceutical dosage forms in Subotica, one plant for the production of solid pharmaceutical dosage forms in Srpska Crnja, and one plant for the production of inactivated bacterial vaccines).

At Veterinarski Zavod Subotica we carry out production in compliance with the following standards:

  • ISO 9001:2015 – Quality management system
  • GMP (Good Manufacturing Practice) – national Good Manufacturing Practice certificate for the production of solid pharmaceutical dosage forms
  • GMP (Good Manufacturing Practice) – national Good Manufacturing Practice certificate for the production of liquid pharmaceutical dosage forms
  • GMP (Good Manufacturing Practice) – national Good Manufacturing Practice certificate for the production of inactivated bacterial vaccines
  • GMP (Good Manufacturing Practice) – national Good Manufacturing Practice certificate for the production of virus vaccines
  • EU GMP – European Good Manufacturing Practice certificate certifying compliance with European pharmaceutical regulations for the production of solid pharmaceutical dosage forms
  • EU GMP – European Good Manufacturing Practice certificate certifying compliance with European pharmaceutical regulations for the production of liquid pharmaceutical dosage forms
  • EU GMP – European Good Manufacturing Practice certificate certifying compliance with European pharmaceutical regulations for the production of inactivated bacterial vaccines
  • ISO 14001:2015 – Environmental Management System (for the provisions of disinfection, deratization and disinsection services)
  • ISO 45001:2018 – Occupational Health and Safety Management System (for the provisions of disinfection, deratization and disinsection services)
  • HACCP (Hazard Analysis and Critical Control Points) – packaging of premix for animal feed
  • ISO 14001:2015 and ISO 45001:2018 for pest control services

At Veterinarski Zavod Subotica we follow the product lifecycle through all phases, according to the ICH Q10 guidelines (pharmaceutical development, technology transfer, commercial manufacturing and product lifecycle end).

Sistem kvaliteta

In the fields of quality, technical management, quality assurance and quality control, we have professional staff, analytical equipment and laboratories for the required activities listed below:

  • Raw material, intermediate, semi-finished and finished product analysis in our own physico-chemical and microbiological laboratories
  • Finished product stability
  • Training, document management, internal control, CAPA, compliance, change control, and annual product review
  • In-process control
  • Batch release
  • Equipment and process validation

At Veterinarski Zavod Subotica, alongside Labiana management, we are committed to make the best possible contribution to ensure an efficient and effective Quality System operations. Click here for more information about Labiana’s Quality System

Sistem kvaliteta