6.2 - Production - Manufacturing Operations 111.60 lot number

lot number

or other extraneous material

You must prepare a batch production record every time you manufacture a batch of a dietary supplement including complete information relating to the production and control of each batch

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

6.2 - Production - Manufacturing Operations 111.60 lot numberEach batch of drug product must be manufactured with the intent to provide not less than 100 % of the labelled or established amount of active ingredient with a completed Batch Processing Record containing a record of the manufacturing formula and processing instructions, completed at the time of performance