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8.0 - Master Manufacturing Record 111.170You must prepare and follow a written manufacturing record (MMR) for each unique formulation and batch size of dietary supplement that you manufacture, including its identity, purity, strength, composition, lot number, overage, and yield, to ensure uniformity in every finished batch and that it meets its specification
you must wear clean
including its identity
Laboratory operations must be under the authority of a person with appropriate qualifications and experience
you must maintain adequate personal cleanliness
components
and arm coverings
You must control the issuance and use of packaging and labels and reconciliation of any issuance and use discrepancies
in-process materials
prioritized by risk assessment
comply with applicable Federal
or contact surfaces
Regular periodic or rolling quality reviews of all authorised medicinal products should be conducted with the objective of verifying the consistency of the existing process
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