Change Control in Pharma, Tool for FDA and Regulatory Compliance

[@AkashGupta-xb2si]

Sir very simple way explained for anyone valso understand a critical point of view in change control

[@Jahid_gamer888]

❤

[@gyaralasandeep685]

Sir make a video on Filter integrity test

[@balanagarajan7905]

Please add English subtitle.

[@pravinsingh8170]

Sir ap qms pe video baniye micro department

[@pravinsingh8170]

Sir autoclave me spors use kase karet hia autoclave validation me

[@pravinsingh8170]

Sir who guidelines me aceptic are microbiology ya production department me clean save karen advice diya hai

[@PHARMAVEN]

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

[@patelvishal2313]

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 ?

[@PHARMAVEN]

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

[@patelvishal2313]

@@PHARMAVEN thank you dear sir

[@SandeepAsok]

Yeh change management Organizational change management se alag hai kya ?

[@pravinsingh8170]

Chane control guidelines hai ya iski sop banani hoti hai

[@PHARMAVEN]

SOP banani hoti hai

[@pravinsingh8170]

Sir change control hai kya kon si guidelines me hai

[@PHARMAVEN]

Mere video me Maine guidelines bataya hai