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contamination and deterioration
or resistance to crushing of tablets
and to propose necessary corrective measures
when such water contacts components
including active materials and excipients
9.0 - Retention Requirements of GMP Records and Reports 111.535 contamination and deteriorationAny production, control, or distribution record associated with a batch of a drug product shall be retained for at least 1 year after the expiration date of the batch or, in the case of certain OTC drug products exempted from expiration dating, 3 years after distribution of the batch, readily available for authorized inspection
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