Visual Inspection in Injectables,
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- Visual Inspection in Injectables, #usfda #visual #inspection #particles @Dhavalkumar Surti #injection
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Few Insights on How to be Successful in Regulatory Inspection in Pharmaceutical Industry, Mainly on Personnel Practices and Procedures
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How to face USFDA Audit
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#DHAVAL SURTI
Few Insights on How to be Successful in Regulatory Inspection in Pharmaceutical Industry, Mainly on Personnel Practices and Procedures
Few Insights on How to be Successful in Regulatory Inspection in Pharmaceutical Industry, Mainly on Personnel Practices and Procedures
Visual Inspection in Injectables, #usfda #visual #inspection #particles @Dhavalkumar Surti #inject
Thank u so much sir
Please spread knowledge 🎉
Tq sir and we are waiting for next vedio.
Thanks Lalitha and more to come, Appreciate your response
@@PHARMAVEN sir visual inspection kya packaging department ke under ata hai ?
@@PHARMAVEN ?
@@yadavharish3150
Visual Inspection is a connecting activity between production and packing, some companies have it under production and some under packing
When company having Central packing dept, it comes under production, otherwise under packing
@@PHARMAVEN Tq sir
Nice sir
Great Sir 🙏
Sir can u plz explain the preparation of standard kit for visual inspection , like number of defective vials, non defective vials, POD, accept zone, gray zone, reject zone etc.
Thanks
Thank you sir for sharing your valuable information.... Can u please more videos about visual inspection.
Yes Sure
Excellent sir
Thanks a Lot, kindly also share to your friends and groups and juniors 🎉
Very nice information
Sir pls post video on lyophilization
Sir kittu process Ela plzz sir
According to which guidelines AQL is performing sir
ISO 2859-1 standard
Thank you so much sir,
And
What is light intensity for clear glass and amber glass.
Which guidelines are followed?
Clear Glass 2000-3750
Guidance USP 790
Amber 8000 to 10000
Dry powder injections manual visual inspections are accepted
See this video
Visual Inspection
th-cam.com/play/PLl7d_zif-t9OViHpHtPCS-2jeXyPLpE_c.html
Should we destroy optical rejection after optical or after full batch is complete
Sir please post video on leak tesing of filled vials. Is 100% leak tesing required for complete batch or samples testing at intial , middle, end of filling is sufficient.
Regards
Kamal Kishor Pant
Dear,
In case of fusion method is used in processing i.e. for ampoules and FFS form fill seal technique 100 % leak testing is compulsory
Where as for other methods e.g.vials and ophthalmic containers 100%leak testing is not mandatory. However adequate confidence should be build for followed procedures
For vial you apply a statistical sampling method to identify batch failure or routine, time or quantity based sampling to identify process failure
Nice sir