9.4 - Records and Reports - Quality Records micro lab

9.4 - Records and Reports - Quality Records micro labQuality 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

or storing dietary supplements

if errors have occurred

Returned or reprocessed drug product shall be destroyed unless examination

or salvage for redistribution

and liquids

Each person involved in manufacturing

composition

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

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

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

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

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