2.0 - Personnel Qualifications and Training management responsibilities You must prepare a batch

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

Procedures shall be used to reconcile the quantities of labeling issued

including written procedures for the tests and examinations that you conduct to determine whether specifications are met

You must verify that the laboratory examination and test methods are appropriate for their intended use for each supplement or drug

The definitions and interpretations of terms in section 201 of the Federal Food

2.0 - Personnel Qualifications and Training management responsibilities You must prepare a batchEach person involved in manufacturing, packaging, labelling, or storing dietary supplements, or in performing any quality control operations, must be qualified by education, training, and or experience to perform their assigned functions. You must assign suitably qualified personnel to supervise.