Many folks here in this blog do mail me regarding Sampling/Dispensing booth. Here are some considerations you must know.These are regulatary guidelines from WHO,FDA and other books.
When I made this document i named it as LAF guidelines.Actually this is not LAF guide. This is regarding sampling and dispensing booths.
Happy reading all.
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Sampling- dispensing.pdf (741.2 KB)
Dear Sir,
Can guide Weighing Balance Qualification is there any model templates can u attach this post
Please find attached Ready to use --QUALIFICATION REFORT OF WEIGHING BALANCE.
Just feed in your data and you can qualify your balance as per protocol. You can also add extra elements if you need.
Note: This site will always help the needy professionals in the fields of Pharma/Biopharma/Food/Medical devices. If you modify the formats or protocol as per any latest guidelines we request you to attach the same as it might be useful to our members and other communities.
GMP is commitment. Knowledge about GMP helps you and community members too.
Regards
qualification Report.doc (143.0 KB)
Dear Durga Prasad Sir
Thanks for the detailed guide line for LAF at dispensing booth and it having good graphical representation, is there any reference to regulatory guideline, if there provide us for taking consideration of the same for implementation.
Is there any specific recommendation of LAF in sampling and dispensing area for API? generally majority of the API manufacturers following the dispensing activity under 5 miron/10 micron filtered areas. Is there any regulatory recommedation for LAF usage , pls provide us…
Thanks and regards
V.J.V.Prasad
ICH Q7A is the guide that covers all such areas. I have posted some months back regarding HOW TO DO document.
Please refer that.
Regards