We are happy to announce that Centro Sperimentale del Latte’s Z2 has been authorized by AIFA to produce pharmaceutical-grade freeze-dried cultures
In a nutshell, pharmaceutical-grade products require high-standard quality systems to be in place, as well as structures, equipment, and processes that guarantee high and consistent quality productions.
Above all, this achievement was the result of hard work and a great team effort by many groups within our company:
The Quality Assurance team managed all regulatory aspects, including application, preparation, and submission of GMP procedures, equipment qualification, process validation, etc., interface with the authorities, and overall monitoring of the project.
The Production team was in charge of operations such as preparation and collection of plant documentation, executing tests, interface with suppliers, and drafting of relevant procedures, among others.
The Quality Control team provided its support in the development of the quality control plan, executing the sampling and analyses necessary for qualifications and validations, etc.
This certification marks another great step on the path to growth that Centro Sperimentale del Latte started some years ago, with the objective to deliver high-quality probiotic cultures and to be a player in the pharmaceutical business worldwide.