Namasthey 🙏🙏 sir. I learnt alot with your video. Please explain about type of declarations required for packing materials and raw materials based source of material manufacturing. For example Animal products - TSE BSE required Protein based products - melamine
Hello sir, it was very informative thank u 🙏 I wanted to ask u, how we decide criticality of raw material for finished product to determine the requirement of audit,
The critical raw material can be API. For evaluation of critical excipient, you need to go through formalised risk assessemnt of excipients as per EU directive.
Vendor qualification for excipients are compulsory? If a material is going to expire after 15 days can we use it however the product self life is 3 years.
Vendor qualification for all vendors are compulsory. For excipient vendors - Audit and also Formalised risk assessment is also required. You should not use such short material expiry material from vendor. I Suggest, take the updated stability data from vendor, do the retesting and then evaluate.
Sir, i meant if we are doing stability study for a product prepared from raw material from new vendor, what is the minimum duration for which stability should be done
This session is how to evaluate vendor. You can use this practice for evaluation of your vendors or suppliers. You can connect with the industries and prove how you are different from others. How your rejection rate is .... and so on...
I suggest you refer to the same video again. You will get the details about the supplier or vendor. Basically, the vendor is the terminology used in India. Overseas, the vendors are called suppliers who manufacture the material.
Sir, there was problem with overseas/outside India vendors... We purchase API front Chinese vendor... Just because out requirements are less vendors don't allow us for onsite audit or they are not allow remote audit.. Not replying offsite assessment fillling then how can we go vendor qualification
Sir which guidline is applicable for KSM manufacturing which are required for API
You need to refer ICH/EU
It's very informative training. Thanks sir.
raju gopale welcome. Keep learning!!!
Namasthey 🙏🙏 sir.
I learnt alot with your video. Please explain about type of declarations required for packing materials and raw materials based source of material manufacturing.
For example
Animal products - TSE BSE required
Protein based products - melamine
I will prepare separate session/lecture on this. Thanks
@@hitendrakumarshah3718 tq sir
hello sir, I learned a lot from this. Thank you for taking time. Please let me know if you perform audit in US.
Yes madam. I can do audits in US also. You can send me details at my email Id: nadhgmp@gmail.com
Yes audable your Voice sir
Thanks
Sir why you stop to upload the video on this types of topics it is very useful for pharmacy students please keep it up. Please don't stop
Sure. I am working on the same. I am planning to have more sessions.
Hello sir, it was very informative thank u 🙏 I wanted to ask u, how we decide criticality of raw material for finished product to determine the requirement of audit,
The critical raw material can be API. For evaluation of critical excipient, you need to go through formalised risk assessemnt of excipients as per EU directive.
Hi sir, this is useful session but may I know the reference guidelines numbers which was refered as per the training slides...plz suggest
I normally refer WHO, EUGMP and USFDA
Sir, overall supply chain evaluation is also required for API manufacturers??
API Supply chain traceability is required for drug product manufacturers.
Vendor qualification for excipients are compulsory?
If a material is going to expire after 15 days can we use it however the product self life is 3 years.
Vendor qualification for all vendors are compulsory. For excipient vendors - Audit and also Formalised risk assessment is also required. You should not use such short material expiry material from vendor. I Suggest, take the updated stability data from vendor, do the retesting and then evaluate.
If we are dng stability, wat is the period for which study should be conducted
Please clarify your question. What is mean by dng?
Sir, i meant if we are doing stability study for a product prepared from raw material from new vendor, what is the minimum duration for which stability should be done
Sir, I have a startup business of screws and bolts it started in jan .. So how to become vendor for automobile industry, other industry like isro
This session is how to evaluate vendor. You can use this practice for evaluation of your vendors or suppliers. You can connect with the industries and prove how you are different from others. How your rejection rate is .... and so on...
Sir, can you please give an emphasis on permutations combinations in case of QRM of vendor qualification.. How can we proceeds
Nice. I will prepare separate training on this topic.
Very nice beneficial
amit gupta Thank you. Keep learning!!!
Sir, this is applicable only for KSM?
No it is applicable for KSM and critical/contributory raw materials
What is the difference between supplier and vendor ?
I suggest you refer to the same video again. You will get the details about the supplier or vendor. Basically, the vendor is the terminology used in India. Overseas, the vendors are called suppliers who manufacture the material.
Dear sir in such case of new product new vendor at which stage the change control need to initiate
It should be raised at conceptualisation stage only. When you think that, you want to go, you need to raise.
Sir, there was problem with overseas/outside India vendors... We purchase API front Chinese vendor... Just because out requirements are less vendors don't allow us for onsite audit or they are not allow remote audit.. Not replying offsite assessment fillling then how can we go vendor qualification
This is the most common problem with so many companies. There are many ways for addressing. I am working on separate detailed video on it.
Sir, pls share the link
Which link?
Sir,total was not explained properly. U have explained a little bit.
What you want to learn. Can you explain in detail so that, I will try to arrange webinar on it.
Yes
Thanks
@@hitendrakumarshah3718 HELP ME TODAY TO MAKE L1 COMPARISON ON GE
Y CATLOUGE ID IS ALREADY GENERETED
Sir please translate in Hindi
If you need to understand specifics, I will explain in Hindi. dont worry