FSI «SID & GP»
The Ministry of industry and trade of the Russian Federation
+7 (495) 676-43-60 109044, Moscow, Lavrov lane., 6

Radiopharmaceuticals and Data Integrity

Today the nuclear medicine is an advanced way of oncologic, neurologic and cardiac diseases diagnosis and treatment, while the nuclear medicine development is impossible without radiopharmaceuticals. As a rule, radiopharmaceuticals are applied to follow all the requirements that sterile medicines must satisfy, including their manufacturing in terms of GMP standards.

At the same time, radiopharmaceuticals possess the following set of features:

  • Small volume series;
  • Short period of validity and the usage until the completion of the quality control campaign;
  • The release and the usage of radiopharmaceuticals based on the evaluation of the series documentation until the completion of all chemical and microbiological tests;
  • The series manufacturing dossier should cover the production conditions and the analytical control carried out before the radiopharmaceuticals were approved for the transportation to the clinical unit;
  • Permission to manufacture is issued after assessing the final results of analytical control and all the deviations that must be documented, justified and approved;
  • If it is impossible to obtain some results of radiopharmaceuticals usage control, there will be a tentative permission for release, but the final permission will be obtained after receiving of all the control results.

These and other product featues contribute to the radiopharmaceuticals manufacturing complexity, which should be resolved by companies that develop and manufacture them. Thereby, the symposiums and conferences are of a great value, where all the radiopharmaceuticals circulation related entities represented on the medicines market (including regulators) can exchange experience. Thus, prior to the VII-th European Conference on Neutron Scattering, held for the first time in Russia, the «Radiopharma-2019» conference took place in Moscow.

There, Igor Falkovskiy, Head of the Department for Good Engineering Practice of the State Institute of Drugs and Good Practices (SID&GP), presented colleagues the «Data integrity and validation of computerized systems» report, in which he described the guidelines prepared by SID&GP, gave examples of specific Data Integrity damages. Speaking about computer validation, Igor Falkovskiy noted that it has features of both qualifications and validations:

  • As applied to hardware, it is equivalent to equipment testing, i.e. qualifications.
  • As applied to software, it is equivalent to process verification, i.e. validations.

In this regard, it is applied to follow the GMP requirements listed below:

  • The validation documentation and reports have to include the corresponding lifecycle stages of computerized systems. The manufacturer needs to justify its standards, protocols, acceptance criteria, procedures and records based on a risk assessment.
  • The validation documentation have to include the revision control records (if applicable) and reports on any deviations identified during the validation process.
  • A current list (registry) of all the computerized systems used should be available, with an indication of their functionality that is subject to the GMP rules requirements.
  • For critical computerized systems, a detailed current description of physical and logical relationships, data flows and interfaces with other systems or processes, required resources of all computer equipment and software and available security measures should be available.
  • User Requirements Specifications should describe the necessary functions of a computerized system based on a documented risk assessment and impact in terms of compliance with GMP rules. User requirements should be traceable throughout the computerized system life cycle.
  • The manufacturer should take all measures to ensure that the computerized system was developed in accordance with an appropriate Quality Management System. Supplier must be evaluated accordingly.
  • In order to validate computerized systems, customized or modified in accordance with customer requirements, it is necessary to develop a documented procedure for controlling the quality and performance of a computerized system at all stages of its life cycle, by forming the corresponding reports.
  • It is necessary to provide the proof of methods and test patterns compliance of the computerized system. In particular, the limits of the system (process) parameters, data boundaries and error handling should be considered. It is necessary to document the conformity assessment of the automated testing tools application and their operating modes.
  • If the data is transferred into another format or data system, the validation should include checking the value permanence and data content during its migration process.