quality standards

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,
ISO 13485, 
21CFR 820 and 211, 
CAN/CSA-ISO 13485,
BGMP (Brazil) 
KGMP (Korea)
I.R. of Iran GMP

Medical Device manufacturer
according to Council Directive 93/42/EEC, certified by 
DQS Medizinprodukte GmbH
(CE 0297) 

Manufacturing authorization
for Medicinal Products
(Regierung von Oberbayern
DE_BY_04_MIA_2011_0023). 

FDA listed contract manufacturer (www.fda.gov,
FDA FEI number 3005689226).

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.