Quality Control: Microbial Limit Tests for Nonsterile ...

Quality Control Quality Control: Microbial Nicole Vu, PhD. Jessica R. Lou, BS. Limit Tests for Nonsterile Thomas C. Kupiec, PhD. Pharmaceuticals, Part 2 Part 1 of this 2-part article contains important facts about the topic of Microbial Limit Tests for Nonsterile pharmaceuticals, including the following statements1: This article represents part 2 of a 2-part article Nonsterile pharmaceuticals are not on the topic of Microbial produced by aseptic processes and, Limit Tests for Nonsterile therefore, are not expected to be pharmaceuticals. Part 1, totally free from Microbial contami- which was published in nations. the International Journal The degree of contamination in non- of Pharmaceutical Com- sterile products is regulated, and is pounding's May-June based on the acceptance criteria for 2014 issue (Volume 18, No.)

308 international Journal of Pharmaceutical compounding Vol o | uly | Auust | 4 www.iJPc.com Quality Control microbiological testing. Written procedures to prevent objectionable organisms in nonster-

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