tachypnea definition: nounRapid breathing.Origin of tachypneaNew Latin tachy- Greek pnoiÄ breathing ( from pnein to breathe ; see pneu- in Indo-European roots.)Related Forms: 1. tachâ²ypÂ·neâ²ic adjective...
New Concept paper on Annex 16 of the EU-GMP Guide. The European Medicines Agency (EMA) has published a Concept paper on revising Annex 16 of the Guide to Good Manufacturing Practice: Certification by a Qualified Person and Batch Release.ince that time, the pharmaceutical environment has been changing and new technologies like, for example, PAT and Real Time Release Testing have been developed. And the implementation of ICH Q8, Q9 and Q10 is having a huge impact on pharmaceutical quality management systems.
SSAE 16 is an enhancement to the current standard for Reporting on Controls at a Service Organization, the SAS70. The changes made to the standard will bring your company, and the rest of the companies in the US, up to date with new international service organization reporting standards, the ISAE 3402.he first difference between the SSAE 16 and ISAE 3402 Standards is that SSAE 16 requires the service auditor to assess the risk associated with potential âIntentional Acts by Service Organization Personnelâ.