GDP covers all activities consisting of procuring
and must be tested or examined to determine whether the batch meets its established specifications of identity
Quality Control must review all complaints to determine the potential failure of a drug product to meet any of its specifications and whether the complaint represents a serious and unexpected adverse drug experience which is required to be reported to competent authorities in the country where it is marketed
identified through a sound statistical sampling plan (or otherwise every finished batch)
4.2 - Equipment Cleaning and Sanitizing gdp GDP covers all activities consistingYou 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