Which samples are tested?
Pharmaceuticals are a very special good. It is not without reason that a particular law exists covering the proper provision of humans and animals with pharmaceuticals: The German Medicines Products Act (AMG). Its purpose is particularly to maintain the quality, efficacy and safety of the medicinal products. These aspects are tested especially rigorously during the approval of a medicinal product. Following the approval, it is the task of InphA to test the quality of the pharmaceutical and in doing so to carry out an independent and random check of the quality control analyses that the pharmaceutical company must perform of every batch of product before it is released to the market.
InphA tests the following types of samples:
- Pharmaceutical products for human use
- Pharmaceutical products for animal use
- Pharmaceutical feeds and their premixes
- Active ingredients
- Non-active medical devices
These samples can take the most diverse forms, e.g.:
- Tablets, pills, capsules, powders, granules
- Preparations for injection and infusions
- Ointments, creams, pastes, lotions
- Emulsions, suspensions, solutions
- Sprays, aerosols, powder inhalers
- Transdermal patches
- Herbal teas
Furthermore, we differentiate between planned samples and suspect samples, depending on the reason for testing (more here).
Which parameters are tested?
For all planned samples InphA has agreed with the competent authorities of its shareholding member states on a standard testing plan, which has been created on a risk-based approach and defines the test that must be carried out for the respective preparation. Despite this standard testing plan the competent authorities can modify the number and type of tests at any time.
In principle, InphA checks:
- Identity and assay of active ingredient
Depending on the preparation and sample, further parameters are tested:
- Related substances
- Subdivision of tablets
- Uniformity of dosage units, Uniformity of mass, uniformity of content
- Disintegration, dissolution
- Sterility, bacterial endotoxins, microbial enumeration test
- Residual solvents
- Testing for Aflatoxins
Depending on the suspicious facts, suspect samples are usually subject to a reduced testing plan.