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  5. 9.0 - Retention Requirements of GMP Records and Reports
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By GMP-SOP-Download Drug

9.0 - Retention Requirements of GMP Records and Reports

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Any 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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GMP-SOP-Download Drug8.8 - Laboratory Controls - Method Validation
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GMP-SOP-Download Drug9.1 - Records and Reports - Production Records
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