Quality Control.
We have established a quality system according to the GMP’s and ISO 9001, which gives us the frequency and the quality controls to be performed concerning the packaging components, raw materials, bulk, finished product, and filling line controls. This quality control is performed by personnel specially trained in these functions with the appropriate technical means.
Microbiological Control.
There is a microbiological control area that lets us carry out all those microbiological controls stipulated by our quality control system or those requested by our Clients on raw materials, finished product, environment, machinery and tools. This microbiological control is performed by skilled personnel with the appropriate technical means such as autoclave, culture mediums, laminar flux cabin, etc, ....
Environmental Management.
We are provided with a quality management system implemented in our Company for the adequate management of all the waste we may produce like R.S.U. (Urban Solid Waste) sewage, paper, carton, containers, oils, emissions, noise, etc,... which ensures us the respect and care over the environment.
Calibration.
The calibration of the equipment, which take part directly in our processes, is performed internal or externally through patterns with primary traceability. This allows us ensure the assays done by our personnel.
Technical and human means.
For the attainment of all the points described above, we have the personnel with the necessary training like Graduates in Chemistry (5), Pharmacy (2) and Environmental Chemistry (1). We have also the following technical means available: pHmeters, viscometers, thermometers, densimeters, alcoholometers, conductimeters, scales, infrared spectrophotometers, V-UV spectrophotometer, autoclave, laminar flux cabin, TOC. Besides, if some kind of assay needed some specific equipment like HPLC, gas chromatography or methods validation, we work together with the Analytical Department of
San Pablo CEU University in Madrid.
Registers.
As collected in our quality and environmental management system, we have registers of the quality and microbiological controls performed and the analysis numbers corresponding to the raw materials and packaging components used in the manufactures, which allows us know at every time the traceability of the products if necessary.
Sampling Room.
We keep a file of samples during at least 30 months (according to the legislation currently in force) or even longer if our Clients request us so, for the performance of the re-analysis in case of complaints or incidences observed.