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Products Packaging and Storage Quality Control
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QUALITY CONTROL:

Capsules

Roxlor provides their customers products and customer service that strive to be the best in the world. Because of this belief, our capsules undergo rigorous inspection procedures. Capsules undergo a continuous series of visual inspections which are performed in accordance with the NF ISO 2859-1 norm. Capsule tolerances are tightly controlled to reach excellent consistency of product and subsequent performance in capsule filling machines.

The setting up of a Quality Insurance system to be preventive and not curative has been one of the first concerns done by leaders. In accordance with the article L. 5311-2 of the code of the public health, the company is submitted to the control of the agency French of Sanitary Security of the Health Products (AFSSAPS). We work according to our manual quality, in conformity with the BPF norms (GMP) and we are certified ISO 9001/2008.

We are also FDA approved. Our DMF number is 14656

With every delivery and every batch we provide our customers a bulletin of physico-chemical and bacteriological analyses in conformity with the requirements of the European Pharmacopoeia.


Gelatin

Since 1999, ROXLOR has exclusively utilized skin gelatin (fish or bovine), to provide our customers with a better, safer product.

Our raw materials are submitted to a systematic review in our QC laboratory. At the time of every delivery, we require a veterinary certificate and a bulletin of analyses attesting a complete conformity to the texts of the European Pharmacopoeia and in particular concerning the relative precautions in the BSE. In spite of the absence of transmission risk of the BSE by vector gelatin, because of the extreme conditions of the extraction process (pH – temperature), we constantly conform to the new European instructions to guarantee you a sure product.

Our requirements follow the evolution of the regulation and we are held aware of their modifications, in particular those concerning the relative precautions to the products including a transmission risk of agents BSE.

Lately, following the two resolutions adopted by the Committee of Public Health of the Council of Europe AP-CSP (99) 10.12.99 and AP-CSP (99) 22.12.99 structural on the application of the guideline 1999/82/CE "Setting up of a process of certification of the products of animal origin including TSE risks", we asked our suppliers to make the necessary steps to provide us gelatin benefiting from a conformity certificate to the European Pharmacopoeia.