9.0 - Retention Requirements of GMP Records and Reports 111.535

9.0 - Retention Requirements of GMP Records and Reports 111.535Any 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

contamination and deterioration

SOP and report form for testing the absence of pathogenic Pseudomonas aeruginosa in products according to harmonized methods USP <62> and EP 2

or resistance to crushing of tablets

including active materials and excipients

You must calibrate before first use

and local requirements and not contaminate the dietary supplement

for example AOAC

monitoring

and to propose necessary corrective measures

supplying or exporting medicinal products or active ingredients

when such water contacts components

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