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

supplying or exporting medicinal products or active ingredients

12 and to limits specified in USP <1111> and EP 5

and to propose necessary corrective measures

You must calibrate before first use

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