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

contamination and deterioration

including active materials and excipients

and local requirements and not contaminate the dietary supplement

monitoring

supplying or exporting medicinal products or active ingredients

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