6.2 - Production - Manufacturing Operations 111.60 lot number

lot number

and storage operations ensure the quality of the dietary supplement and that the dietary supplement is packaged and labelled as specified in the manufacturing record

or other extraneous material

or distribution record associated with a batch of a drug product shall be retained for at least 1 year after the expiration date of the batch or

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