6.2 - Production - Manufacturing Operations 111.60 You must maintain your physical

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

and at the frequency specified in writing by the manufacturer of the instrument and control

lot number

at a minimum

6.2 - Production - Manufacturing Operations 111.60 You must maintain your physicalEach 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