9.4 - Records and Reports - Quality Records micro lab if errors have occurred

if errors have occurred

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

Complete internal audit checklist that ensures every aspect of dietary supplement GMP 21 CFR 111 has been implemented and can be used for periodic self-inspection to determine any gaps where corrective actions and preventative actions (CAPA) can be assigned and mitigated

composition

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

9.4 - Records and Reports - Quality Records micro lab if errors have occurredQuality 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