For biological products, a product license software or amendment should be submitted and authorized earlier than a new MCB may be generated from a WCB. Occasionally, a brand new MCB may be generated from a WCB. For stationary vessels, usually clear-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, leading amino acids manufacturer l99l) attended by the following Center and Field personnel: Wendy Aaronson (CBER), Henry Avallone (NWK- DO), Yuan-Yuan Chiu, Ph.D.
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