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Facility Qualification in Pharmaceuticals
Facility Qualification in Pharmaceuticals
Civil Construction:
Check the room number allotted as per the drawing and design.
Check whether the floor as per the design specification. Whether it is Trimix or Epoxy.
Check coving, material of construction of coving and location i.e. between floor and wall and between
ceiling and the wall. Check for the skirting on the wall.
Check the dimension of the room. Whether it is flame proof or non flame proof. Also check the size of
the room and whether it is as per the design specification.
Utility:
Power: Check location of the connections and its voltage and phase with design specification.
Water: Check supply of potable, domestic hot and purified water supply and number of points.
HVAC supply &return diffusers: Check for number of supply and return air diffusers. Also record the
temperature and humidity. Compare with that of design specification.
Lighting: Check the type of light fixture. Whether it is flame proof or non flame proof. Also check and
record the intensity of light.
Dust extractor system: Check the number of the dust extractor points.
Equipments: record all the equipments that are installed in the area.
Check all the safety systems such as alarm push button, location of closest fire extinguisher, fire
detection system, eyewash station, intercom/ telephone and its location.
Attach all related drawings of the area and their availability with revision status..
Prepare summary report of qualification and shall be reviewed . Variance has to be recorded.
The final report of the qualification shall be reviewed and conclusion should be drawn by head of
production and head of quality control and quality assurance.