For biological merchandise, a product license application or amino acids supplier USA amendment have to be submitted and accepted before a new MCB may be generated from a WCB. Occasionally, a brand new MCB could also be generated from a WCB. For stationary vessels, often clean-in-place (CIP) apparatus could also be encountered. The doc was reviewed and expanded upon throughout a 2 l/2 day workshop (May 29-3l, l99l) attended by the next Center and Field personnel: Wendy Aaronson (CBER), Henry Avallone (NWK- DO), Yuan-Yuan Chiu, Ph.D.
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