and must be tested or examined to determine whether the batch meets its established specifications of identity
and composition of the finished batch
of materials or drug product must be examined visually for appropriate labeling as to contents
identified through a sound statistical sampling plan (or otherwise every finished batch)
You must have all records required readily available during the retention period for inspection and copying by FDA when requested
4.2 - Equipment Cleaning and Sanitizing gdp and must be tested orYou must maintain, clean, and sanitize, as necessary, all equipment, utensils, and any other contact surfaces used to manufacture, package, label, or hold components of dietary supplements using approved chemical agents at the required frequency to prevent contamination