Quality Management
Poulpharm values quality highly and can perform studies and/or analyses under different quality systems such as GLP, GCP, ISO 17025,…
ISO 17025
Since December 2017, the quality system of Poulpharm’s lab was accredited by BELAC according to the ISO 17025 (2017) ‘General requirements for the competence of testing and calibration laboratories’. The ISO 17025 standard contains all the requirements that testing laboratories must meet to demonstrate that they operate according to a quality system, are technically competent and are able to provide technically valid results.
Following methods were included in the scope of accredited analyses:
- Detection of Salmonella sp. according to ISO 6579-1 (2017) in animal manure and environmental samples derived from primary production
- Quantitative determination of total number of germs, by means of impression plates
- Detection of antibodies against gE protein of BHV-1 virus in bovine serum by ELISA
- Detection of antibodies against gB protein of BHV-1 virus in bovine serum by ELISA
- Detection of antibodies to gE protein of Aujeszky’s Disease Virus in swine serum by ELISA
Poulpharm is also approved by HOSOWO for the analysis of hygienograms.
GLP
Poulpharm conducts, both in vivo and in the lab, studies in the preclinical phase under “Good Laboratory Practices” or “GLP”. GLP is a quality system that focuses on the organizational processes and conditions under which non-clinical studies assessing the safety of chemicals with respect to humans, animals and the environment are planned, conducted, monitored, recorded, archived and reported.
GCP
Poulpharm conducts in vivo clinical trials in accordance with VICH GCP guidelines. Compliance with this standard provides assurance to the public regarding the integrity of clinical trial data, and that adequate consideration has been given to animal welfare and the protection of personnel involved in the trial, the environment and the food chain for humans and animals.
Audit
In the context of GLP and GCP studies, we can also ensure the qualification of subcontractors and suppliers at the request of the sponsors. In addition, we can also monitor specific events at subcontractors on request.
Regulatory Affairs
Poulpharm has a RA (Regulatory Affairs) team that can give advice before, during and after the set-up of projects in the area of registration or legal status & framing of products. If required, a market/product assessment can be carried out prior to registration in order to draw up a plan. In addition, we also offer general RA consultancy such as support in preparing registration dossiers, checking labels and packaging, etc.