MCDP validation

GOOD MANUFACTURING PRACTICE (cGMP)
1

Dear sir

i want to validate newly come Multi Column Distillation Plant.

and want to use for oncology preparation.

so please guide me what and when steps i must have to validate MCDP properly.

please reply me

thanks
Ashok

2

[quote=ashok_khandivar]Dear sir

i want to validate newly come Multi Column Distillation Plant.

and want to use for oncology preparation.

so please guide me what and when steps i must have to validate MCDP properly.

please reply me

thanks
Ashok[/quote]

Dear Ashok,

First perfom IQ, In IQ check the requist material, material of construction, Loop cnstruction and design, slope , welding documents (Either orbital or other), loop Pressure test, safety features, calibration certificates and other documentations, In OQ check all the operational commands, PQ will perform in three phases, In first phase, gather one month micribiological and chemical data and make trend after getting succesful results you can supply WFI for production this 2nd phase, the sampling frequency can be reduced and it must be perform at least 2 months, in 3rd phase the continous monitoring initated for nine months and make total one year trend.

Thanks

3

thanks very much for reply

but if i get exact schedule for sampling (also name of test for which sample going to collect) then it is easy for me to validate.

thanks
Ashok

4

[quote=ashok_khandivar]thanks very much for reply

but if i get exact schedule for sampling (also name of test for which sample going to collect) then it is easy for me to validate.

thanks
Ashok[/quote]

Dear Ashok,

Samplig must be perform on daily basis at system components (WFI feed water, after MCDP, return loop, WFU Storage tank) and user pionts.
Tests are define in any guidelines:
Conductivity, pH, BET, Total Aerobic Microbial count, Total Organic Carbon and chloride test)

I Think this may clear your problem, if you still having any problem then you may contact to me freely.

Thanks

5

Dear:
I think, all the job shall be prepared and outlined before you ordered your water still.
Otherwise, how to ensure that the column water still is satisfactory and acceptable to your operation.

Best Regards
Wiston