How to transfer QC procedures for commercial products in pharma industry - ICH and USP guidelines - (Pharmaceutical)
Venue: Online Event
|Event Date/Time: Sep 29, 2011||End Date/Time: Sep 29, 2011|
Once a product goes commercial, measuring the quality, safety, and efficacy attributes of the drug substance and the drug product is crucial. There are well-established ICH guidelines for the validation requirements of typical analytical procedures. In contrast, the requirements for a technical transfer of an analytical procedure from one site to another or within a site to a separate facility are often debated.
It is critical that a robust transfer program be put into place in order to head off issues. Unearthing issues at the drug development stage, rather than during routine manufacture, will improve the overall success of the project.
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