cualificación fluidos gmp qualipharma dDepending on its specifics chemical, microbiological and biological parameters, water can be classified into 3 different types:

  • Potable water (used in early stages of chemical synthesis and equipment cleaning)
  • Purified water (used as excipient in manufacturing of pharmaceuticals, preparation of bulk chemical, others)
  • Water for injections (used as excipient in manufacturing of potentials, preparation of sterile bulk chemicals, others)

The qualification of the water generation and distribution system must be carried out after its installation. Some of the most important point to be taking in consideration are:

  • Study and implementation of a Master Plan
  • Design Qualification (DQ)
  • Installation Qualification (IQ)
  • Operational Qualification (OQ)
  • Performance Qualification (PQ)

Carrying out this qualification fully guarantees manufacturing under the best possible conditions.

This qualification will allow us to understand and to control every stage involve in water production. It serves to determinate the points for improvement in the system and, in particular, to introduce internal control mechanism which will enable the future reliability and consistency of the process of obtaining water and vapour.

  • Reliable water and vapour generation system
  • Mastering the generation and distribution system
  • Understanding the risk and the advantages of the service