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(i) Three months following the expiration date of the final lot of the drug item that contains the active ingredient In case the expiration courting duration of the drug products is 30 times or much less; or23. Does FDA think about ophthalmic drug products1 to get adulterated when they are not manufactured under circumstances that make sure sterili
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Records have to be designed, manually or electronically, through manufacture that demonstrate that each one the ways essential because of the defined techniques and instructions have been in actual fact taken Which the amount and high-quality with the food stuff or drug was as envisioned. Deviations have to be investigated and documented.(d) The ta