Pharmaceutical products have different microbiological specifications that are determined by the nature of the medicinal product, the method of manufacture, and the intended use of the product. These specifications are evaluated using validated tests that are associated with specific acceptance criteria. MAP products are a new delivery system which may be used for delivery of a range of drugs and vaccines. The microbiological specification required for MAP products has been identified as a particularly important consideration for this new delivery system.
We are therefore forming a sterility working / advisory group to provide expert opinion and guidance on the microbiological specifications that may be required for MAP products. This group will report their findings to the Regulatory Working Group, which is part of PATH's MAP Center of Excellence. This work is ongoing and further updates will be provided at a later date.