SAN DIEGO--(BUSINESS WIRE)--Bio-Matrix Scientific Group Inc. (OTCBB: BMSN), a biotechnology company focused on stem cell cryogenics and disposable stem cell/tissue transfer instruments, announced ...
The authors outline a validation approach for the manufacture of a “legacy product,” taking into consideration recent guidelines. The aim is to demonstrate the validity and capacity of the ...
The author describes various manufacturing processes and evaluates whether the guidance can be applied to each of them. In November 2008, the US Food and Drug Administration issued Draft Guidance for ...
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