InphA’s services

Legal requirements

InphA's servicesThe daily challenges in the field of pharmaceutical and applied analysis are diverse. To be able to successfully handle them, it is necessary to have a broad range of services.

As an OMCL InphA is in accordance with the administrative instructions of the German Medicinal Products Act (AMGVwV) “able to test and assess the control methods according to § 22 Section 1 No. 15 AMG and to test the samples according to § 5”.

 What does that mean exactly?

  • InphA must be able to transfer all control methods handed in during the approval of pharmaceuticals by the pharmaceutical companies into its laboratories. This means, bearing in mind the multitude of different pharmaceuticals, that a large number of analytical techniques must be provided and handled.
  • Furthermore, InphA must be able to test suspicious medicinal products which are considered unsafe. This is the case “if, according to the current level of scientific knowledge, there is sufficient reason to suspect that, when used in accordance with their intended purpose, they have harmful effects which exceed the limits considered tolerable in the light of current medical knowledge.” (Definition according to the German Medicinal Products Act, AMG). It is the task of InphA to provide evidence by the tests performed, if the suspicious medicinal product is indeed unsafe.

Specialisation

Against this background and based on the different requirements InphA further extends its already broad range of services successively. The main milestones of the previous years were:

  • Establishment of new procedures for the testing of a new type of pharmaceuticals (biological medicinal products)
  • The extension of the testing possibilities for suspicious medicinal products.
  • Establishment of pharmaceutical-microbiological tests.
  • Establishment of microbiological assay.
  • Establishment of test for particulate contamination: sub-visible particles.

Apart from establishing new analytical techniques, InphA also developed some very specific analytical methods, in order to fulfil customer requirements. Examples are screening for residual solvents or the testing for aflatoxins.