9.0 - Retention Requirements of GMP Records and Reports 111.535 supplying or exporting medicinal products

supplying or exporting medicinal products or active ingredients

including active materials and excipients

and to propose necessary corrective measures

when such water contacts components

or resistance to crushing of tablets

9.0 - Retention Requirements of GMP Records and Reports 111.535 supplying or exporting medicinal productsAny 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