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10.5 LIMITS FOR MICROBIAL CONTAMINATION

10.5 LIMITS FOR MICROBIAL CONTAMINATION

      In the manufacture, packaging, storage and distribution of pharmaceutical preparations, suitable means must be taken to ensure their microbiological quality. Unless otherwise specified in the individual monograph, the non-sterile pharmaceutical preparations should comply with the acceptance criteria given in Table 1 and the herbal drug preparations should comply with the acceptance criteria given in Table 2. 

Table 1 Acceptance Criteria for Microbiological Quality of Non-sterile Pharmaceutical Preparations

Table 2 Acceptance Criteria for Microbiological Quality of Herbal Drug Preparations​

APPENDICES • 10.5 LIMITS FOR MICROBIAL CONTAMINATION
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หมายเหตุ / Note : TP II 2011 PAGE 637-639