3.2 - Plant Sanitation Policy 111.130 relevant to their needs

relevant to their needs

and purity prior to release for production or distribution

including examinations and assays to demonstrate batches of drug product meet established specifications of identity

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

and under pressure as needed

3.2 - Plant Sanitation Policy 111.130 relevant to their needsYou must assign one or more employees to supervise overall sanitation. Each of these supervisors must be qualified by education, training, or experience to develop and supervise sanitation procedures. You must maintain your facility in a clean and sanitary condition and in repair sufficient to prevent components, dietary supplements, or contact surfaces from becoming contaminated.