In the facility, one new laboratory and one micro lab are to be made & established.
Target by higher management has given to the seniors. Time is very less. In that construction is to be done, requirements of facility, HVAC, Temperature, Pressure & RH requirements are to be finalized. Instruments are to be bought, lab setup to be done and ...
In this case, construction is done fast, instruments are also bought and the requirements which could be completed early which are discussed with seniors and higher management are fulfilled.
No one bothered about URS User requirement specification and taking the consent from SMEs, no one tried to find the in-depth requirement of cGMP & Compliance, facility designing. At the last moment at the time of completion URS is made & all the documents are signed.
After a few months lab started working.
Inspection came.
Auditor found the gaps regarding cGMP given 483s.
And to respond company is doing some work of reconstruction and facility-related changes, work is suffering, and giving response to regulations is also one of the biggest challenges.
I think the facility must be designed first with cGMP & Regulatory Requirements.
What is your conclusion?