10.2 - Laboratory Sampling 111.165 and to re-confirm on an

and to re-confirm on an annual routine basis the shelf life of an existing drug or supplement product using ICH principles and guidelines

To prevent microbial contamination of components

EP or other recognised test methods

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 establish a specification for identity

10.2 - Laboratory Sampling 111.165 and to re-confirm on anYou must take, without being a source of contamination, representative samples of each dietary supplement that you manufacture, identified through a sound statistical sampling plan (or otherwise every finished batch), before releasing for distribution, to verify that the finished batch of dietary supplement meets established product specifications