Example: tourism industry
Medicinal Product
Found 2 free book(s)
Guideline on the requirements for quality documentation ...
www.ema.europa.eu80 investigational medicinal product for a given clinical trial and not to provid e guidance on a Company's 81 . overall development strategy for a medicinal product. 82 Nevertheless, for all clinical development phases, it is the respo nsibility of the applicant (sponsor) to
active substance, excipient and primary container ...
www.ema.europa.euoutside of the container sterile) is used to provide a specific protection to the medicinal product, the packaging process should be described, including a risk assessment, since it may affect the sterility of the finished product; for example, trapping moisture between the primary and secondary containers.