• Records and reports stored in blue hard copy folders and electronically on compact disc
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Sub-Part J - Records & Reports

9.0 - Records and Reports - Requirements

£22.00 GBP
£22.00 GBP
Tax included.

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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Records and reports stored in blue hard copy folders and electronically on compact disc