Challenges of the EU 'tissues and cells' directive.
Assisted conception is among many tissue-processing disciplines encompassed by new European legislation on the quality and safety of tissues and cells used therapeutically. These directives have highlighted interdisciplinary differences in some current practices, such as variations in laboratory air quality. This commentary discusses the likely requirements of the EU directives for air quality in tissue-processing laboratories. It also draws attention to the concept of validation. Validation becomes essential to justify all processes, and would be an essential tool to support any deviations from normal 'Good Manufacturing Practices', such as adopting a lesser grade of laboratory air quality.
Hartshorne
Geraldine M
GM
Centre for Reproductive Medicine, University Hospitals Coventry and Warwickshire NHS Trust, Coventry CV2 2DX, UK. Geraldine.Hartshorne@warwick.ac.uk
D019411:Clinical Laboratory Techniques; D004622:Embryo, Mammalian / Q000166:cytology; D004780:Environment, Controlled; D005060:Europe; D005062:European Union; D005260:Female; D006801:Humans; D007753:Laboratories / Q000592:standards*; D008297:Male; D011786:Quality Control; D015203:Reproducibility of Results; D027724:Reproductive Techniques, Assisted / Q000592:standards*; D014015:Tissue Banks / Q000592:standards*; D014021:Tissue Preservation