10.2 - Laboratory Sampling 111.165 To prevent microbial contamination of

To prevent microbial contamination of components

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

Quality risk management is a systematic process for the assessment

Each lot of components

and sanitize

10.2 - Laboratory Sampling 111.165 To prevent microbial contamination ofYou 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