This Guidelines is formulated to provide guidance for further applications of Microbiological Examination of Non-sterile Products: Microbial Enumeration Tests (1105), Microbiological Examination of Non-sterile Products: Tests for Specified Micro-organisms (1106), and Microbiological Acceptance Criteria of Non-sterile Pharmaceutical Products (1107).

Microbiological contamination in non-sterile products may decrease drug activities and even eliminate therapeutic effects, thus bringing potential danger to patient health. Thus, pharmaceutical manufacturers should decrease the microorganism contamination by closely following the guidelines of Good Manufacturing Practice in manufacture, storage, and circulation.

Microbial enumeration tests, specified micro-organism tests, and microbiological acceptance criteria for non-sterile pharmaceutical preparations can be used to examine whether non-sterile preparations, active pharmaceutical ingredients and excipients, TCM decoction slices are consistent with the compendial standard. They can also guide the formulation of microbiological control standards and the microbiological monitoring for intermediates during production processes.

This Guidelines expounds on the microbiological examination methods and standards and how to put them into practice.