9.4 - Records and Reports - Quality Records micro lab to ensure uniformity in every

to ensure uniformity in every finished batch and that it meets its specification

Returned or reprocessed drug product shall be destroyed unless examination

if errors have occurred

and investigate if this may result in a risk of illness or injury

9.4 - Records and Reports - Quality Records micro lab to ensure uniformity in everyQuality 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