URS requirement

Hi,

We are currently in the process of moving some old equipment from the old campus to a new campus. These equipment do not have URS, but have IQ, OQ, and PQ documents. Do I need to create URS for the equipment other than performing the IQ/OQ/PQ? Thank you for your advices.

Rich

Hi Rich
Raise a validation plan for the move. In it discuss and justify the actions you consider to be required.
The regulators have moved on from the stage where you might get away with just IQ/OQ/PQ.
The preferred definition for ‘Validation’; is now given as ‘the verification that the users requirements have been fully satisfied’.

Obviously that means if you do not have a properly constructed and detailed URS, then your validation is flawed right from the start.
Control the development of all your documents using a matrix and raise VP/DQ/VRA/IQ/OQ/P1Q/P2Q. The cGMP regulations and requirements make each one of these documents, with the exception of the VP, mandatory.

It is amazing how simple it is when you just follow the regulations.

Regards
Alex Kennnedy

Hello, can you provide me URS requirenments. I am currently working on project to make URS on vial washing machine. i am currently studying ms in pharmaceutical manufacturing and this project is as a part of my study. So, can you help me please??
We are currently in the process of moving some old equipment from the old campus to a new campus. These equipment do not have URS, but have IQ, OQ, and PQ documents. Do I need to create URS for the equipment other than performing the IQ/OQ/PQ? Thank you for your advices.

Rich[/quote]

like this??

br,
cubica:)


JETT-VialWasherURS.doc (290.0 KB)

JETT-URS.doc (414.5 KB)

Do I understand correct. An URS is required for the moving of Legacy equipment from one place/area to another place/area?! How can one draw up an URS 10 years after the equipment has been perchased and used? Then one may as well create a URS for the equipment and make sure that the specification contained therein will easily pass the IQ/OQ/PQ such as if a compression machine was purchased to produce 400000t/hr but due to age or whatever factor can only produce 250000t/hr (records obtained from production), then specify that the machine must produce 200000t/hr! Presto, all your equipment will pass! I dont see this as correct. With a validation plan clearly explaining the equipment history and the intended move etc, surely one is covered by keeping track of the movement of the various equipment (including the use of the change control system to document the intended change.) With that been said, how does one qualify the Design 10 years on?

Have I lost the plot here or am I been left behind? :slight_smile:

please, help me ! I need to know when must create URS before to purchase equipment or after it? I microbiolog and validation is new field for me. I am from Georgia and there are not enough knowledge and expereance about this science in our country.

Hi Tea, The URS is the User Requirement Specification. Therefore it is the specifications that you want the item/equipment to have. It is done BEFORE so that the supplier can understand what you want them to deliver.

Thank you Dear Waynem for your kindness.

Hi Tea,

Just to clarify - The URS should be exactly what it says, a USER requirements spec. It should be a simple document which identifies a need in terms of the business and is used to present to potential suppliers. The supplier should produce a Design Specification document which answers how your requirements will be met. The validation element tests those design features against the user requirements demonstrating (validating) that it will produce a consistent result.
The most difficult thing about writing a URS is avoiding technical language and not being prescriptive in how something is done. If you work solely in Validation then you are probably not best placed to write the URS - leave it to the System Owner who will understand the needs of the business better.

Waynem - ‘How can one draw up an URS 10 years after the equipment has been purchased and used? Then one may as well create a URS for the equipment and make sure that the specification contained therein will easily pass the IQ/OQ/PQ…’.
Precisely - you only need validate against how the machine is to be used. If the requirement from the receiving area was for a press which could run at 40,000rpm then you wouldn’t bother sending them an old press which you already know wouldn’t cope. If the area wanted a press that could do 20,000rpm and you’ve got one lying around then you knock up a URS based around the known capabilities of that machine and test against that.

My thoughts exactly! In this day and age where time is money and we dont have much of either, (efg) dont waste time completing documentation that has no purpose.

Tx

Hi to all,

I’m New to this site, I’m working in pharmaceutical company, Can anyone share the standard requirements or standard to refer for warehouse building if we want to build New warehouse to store Raw materials and packaging materials.

Hi,
let see WHO Technical Report No. 908 Annex 9, Good Storage Practices for
Pharmaceuticals,

thanks sir,
I’m referring to building requirements for warehouse in pharmaceutical company.
the storage conditions and environmental requirements i have gathered already.