You may need change control to prepare new media fill protocol and batch record. In case validation master plan does not define media fill requirements then you need to revise VMP to include media fill. Also, you need to have a SOP on how to perform media fill in detail
Guideline will talk about good hygiene. Body hair me bahot microorganisms hota hai, skin pe bahot microorganisms hota hai that’s why clean shave, short hair, full gowning to cover open skin is required
Sir very simple way explained for anyone valso understand a critical point of view in change control
❤
Sir make a video on Filter integrity test
Thank you sir
The question is if facility is new and we perform initial media fill then change control is mendetory for new media fill ?
You may need change control to prepare new media fill protocol and batch record. In case validation master plan does not define media fill requirements then you need to revise VMP to include media fill. Also, you need to have a SOP on how to perform media fill in detail
@@PHARMAVEN thank you dear sir
Sir who guidelines me aceptic are microbiology ya production department me clean save karen advice diya hai
Guideline will talk about good hygiene. Body hair me bahot microorganisms hota hai, skin pe bahot microorganisms hota hai that’s why clean shave, short hair, full gowning to cover open skin is required
Sir ap qms pe video baniye micro department
Please add English subtitle.
Sir autoclave me spors use kase karet hia autoclave validation me
Chane control guidelines hai ya iski sop banani hoti hai
SOP banani hoti hai
Yeh change management Organizational change management se alag hai kya ?
Sir change control hai kya kon si guidelines me hai
Mere video me Maine guidelines bataya hai