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Inspection from goods receipt to batch release

Inspection from goods receipt to batch release

Drug Analytics

To ensure patient safety with new drugs and medical products, more sophisticated analytics are needed. With an interdisciplinary team of experts and highly developed analysis methods, the OFI accompanies and evaluates your new developments. As an independent GMP certified partner, OFI supports you with individual consulting.

We accompany you from incoming goods inspection to batch release with qualified and state-of-the-art equipment for chemical and physical analysis. Within this framework, for example, the testing of identity, content and purity or the conformity testing of raw materials is carried out in accordance with the specifications of the pharmacopoeias according to Ph.Eur. and USP.
Determining the shelf life of active pharmaceutical ingredients (API) and drugs is an important part of pharmaceutical development and production. We are happy to perform stress tests for you in order to be able to identify possible degradation products. Stability studies are very important because the active ingredients or the drug itself can change under the influence of environmental factors such as temperature, humidity and light. We are also happy to perform shelf life tests for medical devices.
To ensure the reliability of analytical results, methods must be fully validated. In this way, the identity of any substance can be quantified. Method development is not only necessary in drug analysis. Extractables and leachables studies also require method development to quantify additives, degradation products, and impurities for the regulatory process.
We have excellent know-how in the field of damage detection such as the determination of unknown substances and particles. Impurities are identified and quantified.

Head of Pharma, Medical Devices & Hygiene

Dr. Michael Pyerin
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