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The 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
and Cosmetic Act (the act) apply to such terms when used in this part 21 CFR 211 for pharmaceuticals
13 and to limits specified in USP <1111> and EP 5
SOP and report form for the Quality Control testing to prove the absence or presence of E coli in products or materials according to USP and EP global harmonized methods
You must control the issuance and use of packaging and labels and reconciliation of any issuance and use discrepancies
USP 701 Disintegration 211.42 The requirements and controls ofSOP and report form for the disintegration testing of tablets and capsules according to the method, equipment and criteria specified in USP <701> and EP 2. 9. 1