Pharmaceuticals, diagnostic reagents, disposable medical supplies, and medical equipment and instruments are all complex products that have to be produced and controlled in suitable facilities under the strictest standards of cleanliness and procedures. For this purpose, extensive material has been developed and refined through the years.

One key document has been codified as the Standards for Good Manufacturing Practices (GMP's). These GMP's describe, in exhaustive detail, the criteria for plant design, production processes, quality control procedures and thousands of other details designed to ensure that the production facility and processes generate quality products.

The GMP's for pharmaceuticals are supported by detailed Pharmacopoeia standards, which provide full specifications on the technical characteristics of each raw material and finished product, as well as the detailed procedures and standards to ensure compliance. The principal Pharmacopoeias are the U.S., British and European Pharmacopoeias (USP, BP and Eur.P).

Also, pharmaceutical laboratories develop additional extensive internal procedures to manage every aspect of the production, control, packaging, storage, etc., of their products.

These laboratories use the GMP's and Pharmacopoeias as a frame?work, which they build and elaborate upon to manage their activities. Pharmaceutical products are very delicate and they are only as good as the weakest link in the process, and those details ultimately ensure product quality.

In order to control and monitor the facilities and quality of each individual laboratory and product, most countries have established a governmental entity, which is responsible to independently and objectively regulate pharmaceutical laboratories and products. Such entities include the U.S. Food and Drug Administration (F.D.A.), which is responsible to the public for ensuring product safety, efficacy, potency and labeling.

Because NUBENCO supplies products, not only from its own production, but also from other manufacturers’ countries, and many of its clients do not have the resources or opportunity to control the quality of their products, we consider that our primary responsibility is to ensure the quality of its products. Recognizing that, despite the theoretical framework of GMP's, Pharmacopoeia’s, and ISO standards, there is still a wide variety of product quality, NUBENCO attempts to be very selective in its choice of OEM suppliers.

To accomplish this goal, NUBENCO uses a select number of the most reliable OEM manufacturers, which have been inspected and visited personally by NUBENCO representatives. They all comply with ISO and / or CE standards. In this fashion, NUBENCO ensures that its “generic” products are of similar quality to the more expensive brand name products that they replace.