Відео

@@ojjaarundhathi7971 Section 11.7 of ICH Q7 prescribed to have a control sample of the product fir future evaluation if necessary. The packaging system should be same as the sale pack or equivalent packaging system rmore protected packaging. The control sample should be kept in reserve before the batch is released to the market.

@@ebersonleoraj6728 Even if the factor is below 5 mg/ml, it can be used to estimate water content. 5 to 6 factor is only a guiding reference. USP <921> allows to use KF with lower than 5 factor. Is it clear now?

@@ebersonleoraj6728 You can give the factor below 5 also.

@@mowlisharma3941 Let me make a video soon.

@@mowlisharma3941 please provide your contact number. I'll call you

@@Pavan-lq9bv Yes. Depending upon number of digits after decimal point with reference to the specifications.

@@kkuppuluri Thank you

Thanks for your observation 👍🏻

I'll correct it

It doesn't depend upon whether it is stored at different temperature conditions. It totally depends on 'significant change' in the data beyond acceptable limits. The detailed statistical evaluation can help asign shelf life up to 2x also. Data amenability to statistical evaluation is important. I hope that the query is classified. If not, please let me know. I'll try to explain in more elaborate way.

What do you mean by pool sampling sir will you please explain it

Thank you

You can have rinse sample for easy-cleanable equipment and swab sample for hard-to-reach areas of equipment. You have to evaluate the possible impurities for which the equipment will be cleaned.

Traceable means the source dara of each activity done from start. For example for production of a batch all the input materials, necessary calculations that go into the process to produce final priduct to establish what are all materials and activities gone into the process. I hope that this explanation is useful...If still not clear, please ask again. I can give another example.

Attributable means who did the activity. It is name of the person who performed that activity.

Read as ''source data' in the first line

@@pharmaworldk1473 thank you for your kindly responsed.

Thank you. Try to use these tools for evaluation of QC data for assay, HPLC impurities, KF etc. You get wonderful outcomes

Let me explore soon

You are welcome

Generally, factor will be between 5.0 mg per ml to 6.0 mg per ml. You can also have up to 2 mg per ml KF factor for very low water content samples. Please refer USP <921> for more details.

Tq sir

Sir what is acceptance criteria limit for kf standardization RSD..?

@@ojjaarundhathi7971 It is NMT1.0% or NMT 2.0%, depending upon the capability of the instrument on reproducibility.

@@pharmaworldk1473 tq so much sir

Thank you.

I'll make another video with more indepth information on QR Code soon.

Thank you