This Guidelines provides guidance for determining whether methods in use can be alternatives to the Chinese Pharmacopoeia’s microbiological testing method for pharmaceuticals.

With the rapid development of microbiology, some new methods for pharmaceutical microbiological control have been introduced. The methods can be roughly divided into three types:

(1) growth-based detection methods, such as bioluminescence, electrochemical methods and turbidimetry;

(2) direct detection measurement of viable microorganisms, such as solid phase cytometry and flow cytometry;

(3) specific cell component analysis, such as fatty acid analysis, nucleic acid amplification techniques and genetic fingerprinting.

Compared with compendial methods, these technologies have shown more convenience and rapidity. Some of the technologies have potential for real-time or near-real-time monitoring and make it possible to take corrective measures early in the production and to guide good manufacturing practice. Moreover, the use of new technologies also contributes to reducing costs and improving the inspection ability.

For controlling pharmaceutical microbiological quality, microbiological testing laboratories sometimes use non-compendial test methods (i.e., alternative methods) for a variety of reasons, such as economics, throughput, convenience and the requirement for pharmaceutical products’ better quality. Validation of the methods is required before using them, which should be proved to yield results equivalent to, or better than, the results generated by the compendial method.