The Institute of Validation Technology has released a technical article that provides insight to the HMLT and strategies for obtaining successful validation of the test.
Abstract:
Obtaining successful validations of certain raw materials and finished products can be tricky. Researching the materials beforehand is important.
By working closely with development scientists and chemists, setting appropriate specifications, and performing research, method development trials can be streamlined to produce an adequate method.
Key factors in developing a proper method include some experimentation as well as knowledge of the pH of the material, the water activity of the material, the water solubility of the material, and any antimicrobial properties of the material.
Risk assessments can be used to determine what to test, how frequently to test, the stability programme, and objectionable microorganism identification.
Clear documentation and adequate scientifically sound justifications are necessary so that the any future questions can be easily answered.
Introduction:
The Harmonized Microbial Limits Test (HMLT) was made effective in May 2009. The international harmonisation included United States Pharmacopeia (USP), Japanese Pharmacopeia (JP), and European Pharmacopeia (EP).
Companies were encouraged to revalidate their raw materials and finished products in order to obtain compliance to the enhanced guidance documents prior to the implementation date.
To read the full technical note, please click here.
