Good Laboratory Practice

Good Laboratory Practice (GLP) is a quality system concerned with the organizational process and the conditions under which non-clinical health and environmental safety studies are planned, performed, monitored, recorded, reported and archived.

Principles of Good Laboratory Practice apply to all non-clinical health and environmental safety studies required by regulations for the purpose of registering or licensing pharmaceuticals, pesticides, food and feed additives, cosmetic products, veterinary drug products and similar products, and for the regulation of industrial chemicals.

In Hungary, the National Institute of Pharmacy and Nutrition (NIPN, in Hungarian: OGYÉI) is designated as the national GLP monitoring authority who is responsible for monitoring GLP compliance of test facilities involved in the (national) GLP compliance programme.

NIPN carries out periodic inspection of test facilities and/or auditing of studies for the purpose of verifying adherence to GLP Principles as set out in the Ministerial Decree No. 42/2014. (VIII.19.) of the Ministry of Human Resources on the application and inspection of good laboratory practice.

The current interval between GLP compliance monitoring inspections is not more than three years.

Prophyl Ltd. has been a member of the Hungarian GLP Compliance Programme since 2007. Our most recent inspection by the NIPN was performed in January 2014.

 

Good Clinical Practice for animal studies

Good Clinical Practice (GCP) is an international ethical and scientific quality standard for the design, conduct, monitoring, recording, auditing, analysis and reporting of clinical studies, evaluating veterinary medicinal and other biological products. Adherence to the standard provides public assurance that the data and reported results are complete, correct and accurate, that the welfare of study animals and the safety of study personnel involved in the study are ensured, and that the environment and the human and animal food chains is protected.

Among other services we can assist our clients in conducting the challenge phase of clinical trials of veterinary medicinal and other biological products as test site.

 

Good Manufacturing Practice for veterinary medicinal and other biological products

Good Manufacturing Practice (GMP) is that part of Quality Management which ensures that products are consistently produced and controlled by following the quality standards appropriate to their intended use and as required by the marketing authorisation or by the product specification and requirements.

The principles of GMP primarily concerns personnel, premises and equipment, documentation, production, quality control, contracting out, complaints, product recall, and self inspection. Manufacturing of veterinary medicinal and other biological products is obliged to previous authorization by the competent authority of the country even if only certain steps of the production including quality control are performed.

Adherence of Prophyl Ltd. Immunolab to the requirements of GMP is limited to biological quality control testing covering efficacy studies of immunological veterinary medicinal products.