9.0 - Retention Requirements of GMP Records and Reports 111.535 contamination and deterioration

contamination and deterioration

supplying or exporting medicinal products or active ingredients

and to propose necessary corrective measures

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 contamination and deteriorationAny 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