12.0 - Packaging and Labelling Operations shelf life

12.0 - Packaging and Labelling Operations shelf lifeYou must fill, assemble, package, label, and perform other related operations in a way that ensures the quality of the dietary supplement and that it is packaged and labelled as specified in the master manufacturing record. You must control the issuance and use of packaging and labels and reconciliation of any issuance and use discrepancies

such as head

You must use adequate laboratory facilities to perform whatever testing and examinations are necessary to determine whether components

Failure to meet any specification must be investigated by Quality Control

Components and drug product containers and closures shall at all times be handled and stored in a manner to prevent contamination

You must maintain your physical plant in a clean and sanitary condition using cleaning compounds and sanitizing agents that are free from microorganisms of public health significance and that are safe and adequate under the conditions of use

Your batch production record must accurately follow each step of the appropriate master manufacturing record

to ensure that it functions in accordance with its intended use

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

completed at the time of performance

water supplies

each facility carrying out these activities must hold wholesale distribution authorisation

You must quarantine materials and dietary supplements you receive before you use them in the manufacture of a dietary supplement until you collect representative samples of each unique lot and Quality control personnel review and approve the results of any tests or examinations conducted