Kisuma Chemicals

Case Study: Kisuma Chemicals

How Kisuma Chemicals will be aided in the request of the API-Registration

Kisuma Chemicals is a leading company in the Chemical industry. The company is a producer of synthetic hydrotalcite. This a versatile substance that is used namely by plastic producers. An example of its versality is that it can be used as an anti-corrosive substance in glue, paint, and reinforced concrete. However, in order to expand its versatility, Kisuma Chemicals also wants to import active substances for medicaments. This active substance that will be used for medicaments is known as Active Pharmaceutical Ingredient (API). To ensure that the medicaments arrive safely at the patient, manufacturers, importers and distributors of active substances are required to have an API-Registration. For this reason, Kisuma has enlisted the help of Kader Group (Medical Team of Kader Group is now part of the Certification Experts Team).

The goal of API-Registration

Having an API-Registration demonstrates that your company meets the requirements described in the Good Distribution Practices (GDP) guidelines for active substances for medicaments of personal use. These guidelines have been drawn up to ensure that the quality and manner of production, distribution and importation is good. Every organisation that wants to do something with active substances and/or medicaments must therefore abide to these guidelines. In short, these guidelines are also known as GDP-API.

How Kisuma Chemicals will be aided in the request of the API-Registration

Certification Experts, part of Kader Group, has aided Kisuma in their application of the API-Registration. Additionally, all staff members that are involved with GDP-API activities must follow a training course. This ensures that active substances are handles properly and that they are stored and traded correctly. Kader provided this training for Kisuma and their logistical partner Oldenburger | Fritom, which was received enthusiastically. At the end of the training an exam is given, and despite the difficult questions, all participators successfully completed the training and exam.

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