2.2 - Personnel Training lab oos investigation

2.2 - Personnel Training lab oos investigationEach person engaged in the manufacture, processing, packing, or holding of a drug product shall have education, training, and experience, or any combination thereof, to enable that person to perform the assigned functions. Training by qualified personnel shall be in the particular operations that the employee performs and in relevant GMP

or holding of a drug product shall wear clean clothing appropriate for the duties they perform

and insects

You must maintain your facility in a clean and sanitary condition and in repair sufficient to prevent components

specification acceptance criteria

lot number

Methods requiring validation must be added to the VMP

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

Individual responsibilities should be clearly understood by the individuals and recorded

and local requirements and not contaminate the dietary supplement

There must be at least one laboratory

Quality Control laboratories should be separated from production areas and should be designed to suit the operations to be carried out in them

You must verify that the laboratory examination and testing methodologies are appropriate for their intended use