2.2 - Personnel Training lab oos investigation Methods requiring validation must be

Methods requiring validation must be added to the VMP

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

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

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

2.2 - Personnel Training lab oos investigation Methods requiring validation must beEach 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