1.0 OBJECTIVE:To lay down procedure for perform area qualification of the facility.
2.0 SCOPE:This SOP shall be applicable for perform area qualification of the facility.
4.0 ACCOUNTABILITY:Head of Engineering
5.1 Civil Construction5.1.1 Check the room number allotted as per the drawing and design.
5.1.2 Check number of doors and type of the door.
5.1.3 Check whether the floor as per the design specification. Whether it is Trimix or Epoxy.
5.1.4 Check the vision panel. Whether it is double glazed or single glazed.
5.1.5 Check the false ceiling and its material of construction.
5.1.6 Check the wall finish and type of the paint used.
5.1.7 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.
5.1.8 Check whether there is any hatch provided. Describe its location.
5.1.9 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.
5.2 Utility5.2.1 Power: Check location of the connections and its voltage and phase with design specification.
5.2.2 Water: Check supply of potable, domestic hot and purified water supply and number of points.
5.2.3 Steam: Check availability of low-pressure steam and number of points.
5.2.4 Gas/compressed air: check compressed air connection and number of points.
5.2.5 Drains: check number of drain points and type of drain trap.
5.2.6 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.
5.2.7 Lighting: Check the type of light fixture. Whether it is flame proof or non flame proof. Also check and record the intensity of light.
5.2.8 Dust extractor system: Check the number of the dust extractor points.
5.2.9 Equipments: record all the equipments that are installed in the area.
5.2.10 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.
5.2.11 Attach all related drawings of the area and their availability with revision status.
5.2.12 Prepare summary report of qualification and shall be reviewed. Variance has to be recorded.
5.2.13 The final report of the qualification shall be reviewed by head engineering, head concerned department, concluded and approved by head quality assurance.
Related: Separate Manufacturing Facility is Required for Manufacturing of Penicillin and Non-penicillin Products
6.1 SOP : Standard Operating Procedure
Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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