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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
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with clearly defined areas to prevent mix-ups or contamination with microorganisms
without being a source of contamination
and Cosmetic Act (the act) apply to such terms when used in this part 21 CFR 211 for pharmaceuticals
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
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