The whole product life cycle of the ophthafutur®product lines is controlled by an integrated management system incorporating the activities of all partners involved.
As part of the quality system, the H-value, to determine perflourocarbon product quality, was introduced by pharmpur scientists.
The products are manufactured strictly according to the relevant GMP standards, especially
EU GMP Guideline,
21CFR 820 and 211,
Medical Device manufacturer
according to Council Directive 93/42/EEC, certified by
DQS Medizinprodukte GmbH
for Medicinal Products
(Regierung von Oberbayern
A modular system of manufacturing as well as documentation processes enables optimized and highly efficient validation and qualification procedures of all relevant processes and equipment. On this basis, medical devices and pharmaceuticals can be manufactured on an equivalent quality level. This was and is frequently confirmed by inspections of the world leading health agencies over the last two decades.
The whole ophthafutur® team intends to maintain and further improve the high level of the integrated quality system and to support our customers with related results and experiences.