Before a new batch of culture media can be used for any microbiological tests, particularly under pharmaceutical industry regulations, it must be properly tested for its ability to ensure consistent and reliable results. Central to this is growth promotion testing (GPT), so what are some of the key points around this important test?
Microbiological media considerations
Culture media still lies at the core of most microbiological testing, even in the advent of rapid microbiological methods. Given the fact that media is essential to pharmaceutical quality control testing, including environmental monitoring (EM), sterility testing (ST), as well as process and operator validation, it is important that it is of good quality and performs properly.
A pre-requisite for any reliable microbiological work, as highlighted by ISO 11133:2014, is that culture media must meet established performance criteria to ensure accuracy of results, as so many key pharmaceutical QC tests and procedures depend on them. Therefore, sufficient testing should be carried out to demonstrate:
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