The facilities qualification, qualifies the overall manufacturing / testing / production environment. The requirement is as usual driven from the product processes. Where the product process calls for specific room condition, as defined in ISO 14644 and was in FS209E, the engineers must design the respective process area to enable these conditions to be achieved and maintained. Good engineering principles and practice must be used to protect this conditions as required, using the appropriate quality of air filtration, temperature control, humidity control, air flows control, and differential air pressures controls.
All equipment and utilities used in the process area must be listed in the Facility Qualification, along with reference to the validation documents generated during their qualification.Knowing what standards are acceptable and what is not is the key. Experience shows that the more referenced your protocols are, they better they are for execution. When you allow authors to insert unreferenced and unqualified inspections into documents such as; DQ, IQ, OQ, PQ, along with the associated VMP, URS, VRA, and VP , then you are close to being out of control.
Validation authors are there to raise protocols to verify that equipment is install, in accordance with an engineering drawing. They must use the drawing and should not call up any inspections that are nor referenced on the drawing. This way the drawing is the top document. You want to change the installation - you change the drawing - the authority to change the drawing comes through change control.When you allow authors to call up tests and inspection they think are correct, you are heading for anarchy and regulatory problems. All testing on protocols must show the authority for the test,
  • The drawing reference.
  • The cGMP reference.
  • The VMP reference.
  • The URS reference.

Just instructing authors of these facts is often sufficient to make them realize that they are not designing the equipment, a lot of thought went into the design, at the design stage. These thoughts and the resulting design specification were more than likely the subject of many peer reviews and finally company approval. They can not be altered without going through change control.

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