9.4 - Records and Reports - Quality Records micro lab Returned or reprocessed drug product

Returned or reprocessed drug product shall be destroyed unless examination

You must not reprocess a rejected dietary supplement or treat or provide an in-process adjustment to a component

and closures shall be withheld from use in quarantine until the lot has been sampled

Each person involved in manufacturing

if errors have occurred

9.4 - Records and Reports - Quality Records micro lab Returned or reprocessed drug productQuality records must be maintained for one year after expiry of the last batch implicated, including but not limited to batch disposition decisions, investigations into non conformances, OOS investigations, change controls, CAPA, returns, complaints, recalls, pest control, internal audits, supplier audits, and records of all training and qualifications