Quality

We recognize that it takes more than just quality materials to produce quality products. Quality products begin with quality people and quality processes. For this reason, at Ferron we take quality seriously. Not only does our Quality Assurance system meet regulatory requirements, it has become our competitive tool and it is embedded in everything that we do at Ferron.

Our quality system is ISO 9001:2008 certified in 2009. The whole site is GMP certified by Indonesian Health Regulatory Authority. The facility’s solid dosage line is UK-MHRA GMP certified and we have shipped products to UK. In August 2009, we got a certificate from the TGA-Australia on GMP. In June 2010, we have passed the inspection of manufacturing of sterile - Vancomycin from Regierung von O'Bayern-Germany.

Quality is inherent right from the product idea conception stage. The development process goes through the generation of various specifications, standard manufacturing procedures and analytical testing methods. We even specifically identify the suppliers of the raw material to ensure that the resulting products consistently meet our specifications.

The testing and releasing of material is just part of quality assurance. No less important are the efforts to ensure that all working conditions are met during production. This means that all equipment is properly checked and calibrated, thoroughly cleaned and carefully maintained. All manufacturing and testing procedures are performed as prescribed. Any change and deviation in the process has to be reviewed and documented.

At Ferron, quality does not end after the products are shipped. Product handling after productions, complaints, recalls and return of expired products is managed in a highly controlled fashion.

 

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