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.
Thanks
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.
Thanks
Good question.
[b][COLOR=“blue”]When ever you change or modify a Room these steps must be followed accordingly:
What makes them approve such a document:
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.
Regards
About area qualification (room qualification) -
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.
thanks,
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.
Regards