Any production, control, or distribution record that is required to be maintained in compliance with this part and is specifically associated with a batch of a drug product shall be retained for at least 1 year after the expiration date of the batch
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9.0 - Retention Requirements of GMP Records and Reports
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9.1 - Records and Reports - Production Records
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9.2 - Records and Reports - Laboratory Records
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9.3 - Records and Reports - Holding and Distribution Records
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9.4 - Records and Reports - Quality Records
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9.5 - Records and Reports - Complaints Files
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