Legal basis
InphA performs official testing of medicinal products according to § 64 (3) AMG for its shareholders, the States of Bremen, Hamburg, Hesse, Lower Saxony, Saarland and Schleswig-Holstein. For this, it is named in the “Register of the responsible authorities, institutions and experts for the execution of the German Medicinal Products Act”.
According to the memorandum of association, InphA is allowed to accept orders from third parties, as long as this does not conflict with the tasks performed for its shareholders. In practice, this excludes to work for private institutions, such as private laboratories or pharmaceutical companies. This ensures that the testing performed on behalf of the competent authorities is carried out independently and is free of any conflicts of interest.
Sampling
As part of the sampling performed by the competent authorities, necessary information to conduct an independent testing is also requested from the companies under surveillance (e.g. specifications, testing standards, reference standards). Together with the samples, these are made available to InphA, to enable efficient testing along the approved procedures.
Testing
Up to the start of the testing and during the testing, the samples are stored under controlled conditions. The testing plans are created when all the required materials and documents have been provided. The parameters to be tested are determined in advance. The testing procedures of the pharmaceutical companies are accepted as validated. Should it be impossible or not possible to exactly transfer the test procedures, the newly developed or modified test methods are validated as far as necessary. The regulations of the ICH are the basis of the validation. For analysis, all in the testing of pharmaceuticals commonly used analytical techniques are employed. The result of the testing is documented in a test report, which is sent to the competent authorities in charge together with a statement of the expenditure for the testing.
Handling of the provided information and samples
The handling of the provided information and samples is described in detail in the management system of InphA according to DIN EN ISO 17025. According to this, the provided information is used by the employees of InphA for testing the samples. After the end of the testing, the information is collated, together with the sample related data, and archived for five years. Following this, all documents are destroyed.
The samples are stored in case of objections for five years following the testing and for six month in all other cases and are then disposed of by a specialist firm.
To ensure the confidential treatment of the materials and documents, the work contracts of the employees of InphA contain a confidentiality clause. Furthermore, all employees of InphA are formally obligated by the Bremen Senator for Health under the obligation law. This is tied to a subpoena, which corresponds to that of the employees of public authorities.