10.2 - Laboratory Sampling 111.165

10.2 - Laboratory Sampling 111.165You 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

To prevent microbial contamination of components

All personnel should be aware of the principles of GMP that affect them and receive initial and continuing training

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

and sanitize

You must establish a specification for identity

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

Each person involved in manufacturing

EP or other recognised test methods

Quality risk management is a systematic process for the assessment

and sanitizing operations

Each lot of components

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