Quality Control is an essential phase of the pharmaceutical production process, during which the specifications of the raw materials used in production are checked, the correct storage conditions of the radiopharmaceutical are identified and its release specifications are defined. Quality Control ensures that raw materials are not used and the drug is not released for sale, until their quality has been judged satisfactory. It is not exclusively a laboratory activity, but a real inspection activity that takes place step-by-step and evaluates every aspect related to the quality of the finished drug.
One of the skills that the BeForPharma team offers to its customers is to define the specifications of the radiopharmaceutical product and perform all release tests in accordance with these specifications. In fact, the European and Italian Pharmacopoeia, in addition to current legislation, detail the quality requirements of radiopharmaceutical products, whether they are used for diagnostic or therapeutic purposes. Also they provide that highly qualified personnel are responsible to perform all the mandatory analyzes in the healthcare facilities for the delivery of the radiopharmaceutical and subsequent administration to the patient.
These checks concern, by way of example: activity, chemical-physical purity, radiochemical purity, radionuclide purity, residual solvent content, pH, bacterial endotoxins, sterility.
Thanks to an incomparable international experience, BeForPharma supports healthcare structures in the development of new analytical, chemical-physical and microbiological methods, necessary to guarantee the quality of the radiopharmaceutical. Each analytical study is customized to the customer’s needs in compliance with international guidelines and in line with the requirements of the competent authorities.
The current legislation on the matter requires, in fact, that the development of a new (not 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. Furthermore, it is mandatory that all analytical methods used for the delivery 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 customer 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 right validation procedure, up to its application according to the ICH guidelines.