Technology Transfer in Pharmaceutical Industry

This training session will make you understand about brief ICH Q8 guide for pharmaceutical product development. Further the concept of quality by design, Process analytical technology,design space shall be discussed with example so that, the learners will get clear with the concept. During this session, further different aspects of technology transfer, process transfer, analytical method transfer, developing the technology transfer team, responsibilities of that team, phases of technology transfer shall be discussed to explain in detail about this concept.
AA. Vedic Gyan. KD,PHARMA PORTAL,Prof.Karan Ajay Gupta,Pharma Pill,Vivekanand Education Society's College of Pharmacy,

[@suvarnachaure3826]

😊

[@hitendrakumarshah3718]

Thanks

[@nabil1696]

Thanks sir for this session
My question : for transferring production from site 1 to site 2, in which cases bioequivalence study is mandatory ?

[@hitendrakumarshah3718]

There are so many criteria based on formulations and the nature of the product.

[@mitshah4208]

Sir Please make Video on Inventory control MFR BMR and Validation master plan

[@hitendrakumarshah3718]

Sure

[@rajathathireddy3285]

Hi sir, when your planning for next presentation sir, I have requested to take ppt on vendor management.

[@hitendrakumarshah3718]

Yes. Next training we will have on Vendor Qualification. Don't worry !!!

[@gamerstwins9574]

Hi sir

[@jayachandrank1075]

Hello Sir
Can you explain what is difference between Deviation and Incident(Event). There is lot of confusion in industry in differentiating between these two. Can you enlighten with some examples.
Suppose someone had not performed one parameter of say Friability test during In process test ...is this deviation or Incident......... one person found not wearing gowning in production area ? or spillage of material ?
Appreciate your reply

[@hitendrakumarshah3718]

If you refer the GMP guideline, the terminology- 'Deviation' is only used. However for practical approach, many companies are using terminologies as, incidents, lab incidents, notifications, erros,NCR etc and so on. If there is confusion between these terminologies, there is always risk of non conformance. I suggest to put clarity in your SOP why the terminology of incident is used. Hope you clear your doubt. for clarification, you are welcome !!!

[@jayachandrank1075]

Hi Sir, one question
Is LAF and RLAF same? if no can you explain what is the difference with example where both are used.

[@hitendrakumarshah3718]

There is difference between LAF and RLAF. LAF is used to prevent contamination. Due to direction of filtered air in laminar form, the sample gets protected from human and surounding contamination. While RLAF is having air for reciculatory type and protects human from contamination from the sample or materials. in short, for biological or microbiological activity, LAF is used while for sampling of RM, RLAF is used.

[@jayachandrank1075]

@@hitendrakumarshah3718 thanks

[@SmileeAnil21131]

1. What is the content in TMP .....
2. What is the content in TT report...
3. Who will provide TT report.
4. What is difference between TT report and MT report.

[@hitendrakumarshah3718]

TMP is technology transfer master plan. On the basis of TMP, you can prepare individual TTP for each transfer and prepare TTR. Once complete product range transfer from SU to RU, you can prepare TMR and get sign off by authorised person from RU. Hope you got fair idea about documents.

[@SmileeAnil21131]

@@hitendrakumarshah3718 Sir..
1. For method transfer we are preparing protocol and based on out come we are preparing report for that...it is for method...
2. For process we are preparing trial proposal (protocol)to execute the batch and to know process capabilities or fixing the ranges w.r.t process on TLC, WC,LOD, other parameters...then after we are preparing report....
3. After trial we are validating the process...
So, Method transfer and trial batch execution are call as TMP and TMR...is it correct sir...or any additions required..plzz clarify
Thanq......

[@SmileeAnil21131]

Please provide clarification on this

[@bhausahebhingade3541]

Thanks you sir very nice

[@hitendrakumarshah3718]

Welcome. Keep Learning !!!

[@sachinsuryawanshi4697]

What is cpk ??

[@hitendrakumarshah3718]

I suggest, you can go through the session on product quality review to understand this concept.
th-cam.com/video/mFC3XNes-pA/w-d-xo.html