Example: dental hygienist
Risk Assessment Guide For Pharmaceutical Excipients
Found 2 free book(s)
Qualification of Excipients for Use in Pharmaceuticals
ipecamericas.orgThis guide is applicable to all excipients used in pharmaceutical dosage forms. 1.3 Principles Adopted When considering how to use this guide, each excipient supplier must consider how it may apply to their material and processes. In addition pharmaceutical formulators should consider the proper use of the excipient in their formulation.
Guideline on quality, non-clinical and clinical ...
www.ema.europa.euERA – Environmental Risk Assessment . FIH – First in Human . GCP – Good Clinical Practice . GMP – Good Manufacturing Practice. GMO – genetically modified organism . GTIMP – Gene Therapy Investigational Medicinal Product . ICH - International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use