9.0 - Retention Requirements of GMP Records and Reports 111.535 or resistance to crushing of

or resistance to crushing of tablets

contamination and deterioration

including active materials and excipients

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

9.0 - Retention Requirements of GMP Records and Reports 111.535 or resistance to crushing ofAny 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