Criteria for Gowning Qualification. How many gowning qualifications to be taken to evaluate the procedure. Whether qualification is required individually for a person entering into the different aseptic areas within the same block.
Gowning qualification is determined through post-gowning microbiological sampling. In the 2003 draft guidance document, re-qualification is recommended semi-annually, or yearly for automated operations with minimal personnel intervention.
The trained employee shall be allowed to enter in the aseptic areas and the surface counts on the fingers tips, armpits, buttocks, forearms etc shall be taken on the gown. The surface counts shall not exceed beyond the set acceptance criteria ,normally considered as < 5 or < 1 depending on the location. This activity shall be performed for three consecutive days. If the employee has the count of less than pre defined acceptance criteria for all three days and all locations , then the employee shall considered to be qualified for gowning.
Hi,
Useful information. I would like to get more information on Environmental monitoring in sterile production facility in Pharmaceuticals. Your help will be much appreciated.
Thanks.
Durga u have given good information, in addition to that you have to monitor qualified personnal for Aseptic behaviour also.
Qualified personal should take part of Media Simulation activity atleast once in a year.
Limit : Gowning Qualifciation : Depends upon personnel working in ISO grade.
Neha: If you want to read more about EM,Referrance are as below,
Guideline for sterile manufcatufing By USFDA (Sep. 2003)
PIC’s Guideline.
TGA and Orange guideline.
For Non viable monitoring and classification - ISO guideline.
This all are readily available on internet.
If you not able to get ,mail me i will provide u.
Pankaj.
[quote=sojitra_pankaj2003]Durga u have given good information, in addition to that you have to monitor qualified personnal for Aseptic behaviour also.
Qualified personal should take part of Media Simulation activity atleast once in a year.
Limit : Gowning Qualifciation : Depends upon personnel working in ISO grade.
Neha: If you want to read more about EM,Referrance are as below,
Guideline for sterile manufcatufing By USFDA (Sep. 2003)
PIC’s Guideline.
TGA and Orange guideline.
For Non viable monitoring and classification - ISO guideline.
This all are readily available on internet.
If you not able to get ,mail me i will provide u.
Pankaj.[/quote]
Dear Pankaj,
Can you please provide me the same?
Regards