Allowable maximum gap between static area qualification to dynamic area qualificatio

GOOD VALIDATION PRACTICE (cGVP)
1

Dear All forum members ,

I want to clear one of my problem related to Area Qualification for biotechnology bulk Manufacturing area the allowable maximum gap between static area qualification to dynamic area qualification , if all the validation parameter under control during the gap period and for that any guideline available which status the same ?

Regards
Himanshu C

2

Hi,

AT-REST: (AT Static)
ITS A CLEANROOM THAT IS COMPLETE, WITH ALL SERVICES FUNCTIONING AND WITH EQUIPMENT INSTALLED AND OPERABLE OR OPERATING, BUT WITHOUT OPERATING PERSONNEL IN THE ROOM

AS-BUILT: (AT Dyna,mic)
ITS A CLEANROOM THAT IS COMPLETE AND READY FOR OPERATION, WITH ALL SERVICES CONNECTED AND FUNCTIONAL, BUT WITHOUT EQUIPMENT OR OPERATING PERSONNEL IN THE ROOM.

I Suggest you there is no gap period requirement for this two study.

After Completion of Static area qualification from next day onwards you have to go for Dynamic condition.

In Dynamic condition Microbial Monitoring is must because it is the major differant in this two condition in dynamic condition personnel occupacy is cover.

If any gap is there in this two study so in this GAP period u have to critically monitor the area for Temperature, RH, Diffirential Pressure, Microbial monitoring, If Possible noise level also.

If Any Clarification is required please fill free to contact me.

Have a nice day.

Thanks,
Pankaj sojitra.
sojitra_pankaj2003@yahoo.com
M:9979842207.