Room Qualification

Can somebody clarify what is and what is not required if a room is changed.

New eqpt, ceiling changed etc.

Do they have to repeat any of the original qualification activities.


Good question.

[b][COLOR=“blue”]When ever you change or modify a Room these steps must be followed accordingly:

  1. A change control document why this Room must be changed or Renovated?
    2.What are the Risks of Changing and Impact assessment of such change?
    3.Changing this room certainly effects the process or production activities. If that is so which departments are effected and their concerns and a document replying to all their concerns.
    4.Review and final approval of this Change.(Engg, QA, QC, Production must approve)
    5.Implementation of this change.

What makes them approve such a document:

  1. Design of the room.
    2.What should be changed?
    3.Components that is comming during the change and what components are removed?
    4.Is there is a change in dimensions of room? If so please tell in Hieght, Length or Breadth-- Electrical fitting changes and their concerns, Alarams change and their concerns,HVAC system and their change + impact, Lighting LUX levels earlier and their change, Paint change,Piping changes and any damage control to pipes, Ceiling material change, Orientation of Equipment change and impact on flows, Change in Room door size or Direction of opening or Sides of opening and their impacts on movement of men and materials, Change in number of staff working in room as per new changes.
    How this change improves or even having a negetive impact on GMP and Quality management systems.
    Did you fit any materials already exisiting earlier in that room and what is their physical and material condition before that change- During that change(Renovation)-After that change in the room?

Write down all specifications
Get down to a URS
Get approved the URS
Get the designs of room
Get Flow of room
Get Flow of materials in that room
Get it approved as per Qualification procedures for Materials, Machines, Paints, Pipes, Electrical equipments, Sensors etc etc.[/color][/b]

Change is necessary. But making a change must be very proper in GMP.

About area qualification (room qualification) -

  1. whether HVAC system shall be qualified 1st & then area qualification or the area shall be qualified 1st & then HVAC system?
  2. for shifting of machine from one room to another room whether Area qualification shall be repeated or not?
    can someone reply to my query.

1. Qualify the Room first. Then qualify the Electrical systems. Then qualify the lighting, Then qualify the HVAC. (Rule is you must first qualify the ROOM first and then the immediate needs or Supports or Utilities. It is noted untill room is not qualified there is no point in bringing the utilities inside that.)

2.Qualifification of area is a must when you shift equipment from one place to another like wise the above point No:1. In this praticular issue you need to write a change control why you are shifting that particular equipment etc etc. You need to qualify that room, bring this equipment, Install the equipment, Requalify all controls and process validation parameters with that particular equipment should be validated.


But if we qualify 1st the room &then utilities, then what is the final area release checklist (area qualification shall be check list of all room specifications & utilities)

The area qualification and the utility and support requirement comes under one domain.
There is a reason for this. You need to know all the utility requirements before you house an equipment. In the same way you need to know the room space, dimensions , containment aspects, Airchanges, Lighting levels, User points if you have WFI or pure water, Gas distribution user points and entry-exit procedures.(Inside the room, Into the room and on top of the room and either sides of room and number of view mirrors too).

So as a document you need a check list that qualifies the room first. Then the electrical systems, lighting, door interlocking, Any fire safety detectors. This is followed by the utility check list.

There is no point in qualification of other things first and later the Room qualification. In GMP procedures there is a reasoning. It must be based on Individual companies on YES-NO basis.

What are your Requirements & what are your specifications you need to write first. Did they match those requirements &specifications or there are any excurions in GMP’s you need to know.

It comes on logical thinking, team effort and experience.This is a bigger effort. No single person can deliver what a process room needs. It needs a lot of Engineering, Safety, GMP, containment & process know how.Once it is made a person who is having enough qualifications and who has knowledge about Regulatory guidances need to certify this document to go ahead with implementation programme.