home       
   
 
 
Quality Systems
 
Quality is an essential element of the technology area in which Biotecnol operate. A manufacturing process must withstand the high standards required by GMP. Development activities should be carried out under the rigorous control of a quality system assuring that all data are reliable and accurate.
 

Biotecnol´s quality system encompasses the organisational structure, procedures, processes and resources necessary to ensure that all work carried out meets exacting requirements.

Principles of GMP/GLP are applied in "all" development activities e.g.

  • Instruments and equipment, key to controlling parameters, measuring and providing analysis, are calibrated and validated on a routine basis.
  • Established and routine procedures, covering both specific and general tasks, are documented in the form of SOPs.
  • Personnel are qualified and trained to effectively carry out the activities for which they are responsible.
  • An organised document structure is maintained and traceability of all information is assured.

Quality is the responsibility of  all persons involved in Biotecnol´s activities, both internally and externally.

 
Biotecnol is committed to provide a high level of quality and continual improvement to satisfy both internal and external demands effectively.