Test Methods Development and Validation
BeForPharma brings a wealth of incomparable international experience to its work with health facilities in the development of the new chemical-physical and microbiological analytical methods necessary to guarantee the quality of radiopharmaceuticals.
Each analytical study is tailored to the needs of the customer in accordance with international guidelines and the requirements of the competent authorities.
The current legislation in force requires that the development of a new (non-compendial) method takes into account a careful study of the production process and a careful evaluation of its critical points, according to a verified risk assessment approach. It is also mandatory that all analytical methods used for the release of a medicinal product are validated, i.e. that their suitability for the purpose for which they have been developed is proven.
In this context, BeForPharma supports each client both in the development of the new method, which takes into account the critical points of the process as well as in the choice of the correct validation procedure, and in its application according to the ICH guidelines.