Good Manufacturing Practices (GMP) in Warehouse

This is first part of video for GMP in warehouse area. This is prepared as per FDA expectations. This video is in simple and easy to understand english language.LEARNINGPHARMACY.IN,AA. Vedic Gyan. KD,PHARMA PORTAL,Prof.Karan Ajay Gupta,Pharma Pill,Vivekanand Education Society's College of Pharmacy,

[@Nileshpatel-ih7me]

Good explanation sir

[@hitendrakumarshah3718]

Thanks and welcome

[@arunthakur6828]

👍👍👍👍👍

[@hitendrakumarshah3718]

Thank you. Keep learning !!!

[@krishnadesai6953]

Sir how can sterile raw material sampling? If active material suppose St. ceftriaxon sodium received 100 container .

[@hitendrakumarshah3718]

You can request vendor to share separate package as sterile sample along with sterile material. So that, the sterility of the material will not be compromised.

[@sainathladdu4109]

Superb

[@hitendrakumarshah3718]

Thank you for your comment. Keep Learning !!!

[@krishnadesai6953]

If I sampled from all container.... Is there chances for break the sterility?

[@hitendrakumarshah3718]

Sorry ... You can question is not clear. Please provide details

[@gauravsharmamtvnlvideos]

Sir, composite sample required or not if required what will be the process

[@hitendrakumarshah3718]

This is what I was expecting from this video. You are the first one. Great. See, Composite sample is required. But if, it is required to sample separately for top, middle and bottom, you should take separate sample and should not mix to get composite.

[@bkvnagireddy7816]

Can I perform analysis without standard COA in which there is no information about potency/assy/purity of the standard..any FDA 483s on this issue

[@hitendrakumarshah3718]

If you dont have potency or assay of standard, how you can perform testing? FDA 483 - I need to check it. You can verify from the FDA warning letter/483 database

[@bkvnagireddy7816]

@@hitendrakumarshah3718 sir, Please provide any 483 if available

[@bkvnagireddy7816]

@@hitendrakumarshah3718 thanks for ur reply sir..

[@rajeshbabu9009]

On what basis we take fp samples, reserve samples, Aql samples and warehouse samples
What are the guidelines explaining about sampling procedures sir

[@hitendrakumarshah3718]

There are many inspection guides for example AQL,ANSI etc. You have to validate your cleaning procedure so as to prove that, your sampling activity will ensure that the possible defect can be detected.

[@manojmunjal392]

Nice session

[@hitendrakumarshah3718]

Thank you dear

[@rajumulakala5439]

Excellent

[@hitendrakumarshah3718]

Thank you for your kind comment. Keep Learning !!!