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Klifovet decided in the very beginning to get certified to the ISO 9001 management system standard which sets out the requirements for a quality management system. This helps to be more efficient, to improve customer satisfaction and is a way of showing customers and other interested parties that Klifovet has an effective quality management system in place.

A new version of the standard, ISO 9001:2015 has been launched in November 2015, replacing the previous version (ISO 9001:2008). Certification according to the ISO 9001 standard means that a conformity assessment by an independent third party and the provision of written assurance (a certificate) confirms that Klifovet and its system meets the specific requirements of the DIN EN ISO 9001:2015.

International Organization for Standardization

Good Manufacturing Practice (GMP) describes a production and testing practice that helps to ensure the quality of the manufactured products. While initially established for medicinal products, it also applies for veterinary medicinal products (VMPs). For feed products, distinct guidelines and requirements were established, nonetheless with the same objective of assuring the consistent manufacture of high quality products. Nowadays, veterinary medicinal products must be produced according to GMP standards during the complete manufacturing process, starting with the individual active ingredients and including all steps from fermentation, formulation, filling, freeze drying and storage until the final processes of labelling, packaging and release. The same principles also apply to investigational veterinary products (IVPs) and reference products used in clinical studies in Europe. Since 2007, KLIFOVET is accredited to GMP by the government of upper Bavaria for the re-packaging and labelling of veterinary clinical supplies. In 2016, this license was extended to labelling, packaging and release of commercial batches of pharmaceutical VMPs. In the same year, KLIFOVET was accredited to GMP for the re-packaging, labelling and release of veterinary vaccines, both for batches to be used as clinical supplies and for commercial use.
Since 2011, KLIFOVET also holds a wholesaler distribution license for veterinary medicinal products and is authorized since 2008 to place feed products on the market.
Directive 91/412/EEC applies for medicinal products intended for veterinary use.

Good manufacturing practice (GMP) Guidelines

The primary objective of the OECD Principles of Good Laboratory Practice (GLP) is to ensure the generation of high quality and reliable test data related to the safety of industrial chemical substances and preparations in the framework of harmonising testing procedures for the Mutual Acceptance of Data (MAD). The GLP standard has evolved to be the standard for studies where data is gathered on animal, the environment, user and consumer safety and is nowadays required or recommended for certain tests in animals for veterinary and medicinal products and biocides, and recommended for feed additives. Care must be taken applying the OECD GLP guidelines to studies, that also shall be applicable to some specific countries organisations like FDA and EPA.
At KLIFOVET we work with well selected partners who have been accredited for GLP while we assure to our clients the quality incl. animal welfare standards.

Principles of Good Laboratory Practice

‘The purpose of the VICH Good Clinical Practice (GCP) is to establish guidance for the conduct of clinical studies that ensures the accuracy, integrity and correctness of data’.
Good Clinical Practice was established by the “International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products” (VICH) as Guideline No. 9 and implemented in the year 2000 by the VICH Steering Committee. Since then, efficacy studies testing VMPs and to be used for registration purposes shall follow this guidance document.
At KLIFOVET, we have implemented the GCP requirements in our SOPs, that are incorporated in an ISO 9001:2008 quality management system to assure high and consistent quality to our clients.

VICH Good Clinical Practice [PDF]

DIN EN ISO 17025 accredited suppliers KLIFOVET uses ISO 17025 accredited laboratories whenever possible and available. The ‘International Standardisation Organisation’ with its member organisations of the ‘European Committee for Standardisaton’ (CEN) and ‘Deutsches Institut für Normung’ (DIN) have implemented a quality management standard called DIN EN ISO 17025 detailing the general requirements for the competence of testing and calibration laboratories. ISO 17025 developed to be the standard for laboratories involved in food, feed and clinical examinations in the animal health and nutrition area. The use of ISO 17025 is legally required in many instances in Europe. Full validation of methods applied is required to obtain and maintain accreditation and the ISO 17025 standard assures the generation of trustful and consistent results.

International Organization for Standardization