10.6 - Laboratory Microbiology Testing Overview garden there must be a comprehensively

there must be a comprehensively designed and correctly implemented Pharmaceutical Quality System incorporating Good Manufacturing Practice and Quality Risk Management

such written procedures shall be followed

You must identify and quarantine returned dietary supplements until quality control personnel conduct a material review and make a disposition decision to either reject and dispose of the products

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 hold or retain reserve samples of each lot of packaged and labelled dietary supplements that you distribute

10.6 - Laboratory Microbiology Testing Overview garden there must be a comprehensivelyThe requirements and controls of the QC micro lab to perform microbiological testing of non sterile products to USP and EP harmonized methods without erroneously contaminating the growth media by untrained personnel, environment, equipment, calibration, media, reference standards