The "ownership" of media fills should properly lie with the management of the aseptic process. Properly, media fills should be scheduled into the manufacturing program in the same way as a routine filling activity except that the product is units filled with media. In practice, this ownership tends to be held jointly between production and microbiological QA. Numerous microbiological considerations and controls must be complied with for a media fill to be fit for its intended purpose within the QA program.
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