SubscribeIn a major step towards global harmonization of pharmaceutical product testing, the European, United States and Japanese Pharmacopoeias have revised their regulations on microbiology testing.
The new regulations came into force in Europe in January 2007, and in the US and Japan in May 2007.
The structure of the relevant chapters in the USP and JP was changed to follow the structure of the EP. This resulted in new chapters <62> and <1111> in the USP and in a splitting of chapter 35 in the Japanese Pharmacopoeia. Table 1 gives an overview of the harmonized chapters.
Pharmacopoeia Changes due to Harmonization
Table 1: Chapters of European, US and Japanese Pharmacopoeias affected by the harmonization of the microbiological testing.
The harmonization has resulted in significant changes in the testing procedures and the microorganisms that must be included in tests.
Major changes addressed include changes to incubation times and temperatures, inclusion of membrane filtration method, and more detailed description of methods for validation (suitability) and demonstration of media-growth promotion. Furthermore, some reference microorganisms have changed. The USP now prohibits formerly allowed retesting using a 25 g sample. More details on significant changes in the EP and USP can be found in Table 2.
As a consequence of all these changes, the pharmaceutical industry will have to adapt product-specific test methods to comply with the new regulations. Revalidation of existing tests will be required for many existing products, resulting in an enormous effort. Regulators are allowing for a transition period into 2009 or 2010. In Europe, substances with specifications in the monograph can use old methods until the monograph is revised (expected to be in January 2009). Other substances without monograph and preparations before January 2010 can use either the old or harmonized methods. After January 2010, only harmonized methods can be used. In the US, new methods must be implemented by May 2009.
Microbiological Testing Method Revalidations
Table 2: Some changes in the European and US Pharmacopoeias due to the harmonization of microbiological testing
The workload for implementing these changes will be very high. Method adaptations and revalidations should be tackled early in order to not miss the deadlines. The exact scope of required method adaptations and revalidations depends on the pharmaceutical product and the methods and documents already in existence, which means that each case should be looked at individually. Due to the enormous workload, organizations may want to consider outsourcing the work and seeking expert help.
Solvias has already adopted the new regulations and has the expertise to help customers in the pharmaceutical industry to make the right decisions. Solvias can take over the method adaptation and revalidation work, ensuring a smooth transition to the new requirements for microbiological testing. Packages comprising various products can be specifically tailored to provide cost-effective solutions. Thanks to its broad portfolio and know-how, Solvias can also provide entire analytical packages and offer optimum outsourcing solutions for all kinds of analytical services - even beyond microbiology.