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Media fill trials have to be carried out on a semi-annual basis for every aseptic process and additional media fill trials really should be executed in case of any modify in process, procedures or devices configuration." Double-strength media has diverse ingredients but is never to be construed like a "media focus" to which h2o can be additional.
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When proper, time limits for the completion of every period of creation shall be set up to guarantee the caliber of the drug item.Holders of authorised new drug programs for OTC drug solutions are expected under § 314.70 of this chapter to supply the company with notification of changes in packaging and labeling to comply with the requirements of
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