Overview of Sterile Injectable Manufacturing Process (Liquid and Lyophilized)
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- Опубліковано 6 сер 2024
- Overview of Sterile Injectable Manufacturing Process (Liquid and Lyophilized)
This Video Presented By:
Palash Chandra Das, M.Pharm (Pharmaceutical Chemistry)
About Myself:
I have completed my B.Pharm and M.Pharm in Pharmaceutical medicinal chemistry from WBUT. In the year 2010, I started my journey in the Pharmaceutical Industry. In my career I worked with the F & D, Production and Quality Assurance department etc. I have a good exposure in several Sterile Green field and Brown field projects. Involved in various regulatory audit like CDSCO, WHO, USFDA,TGA,MHRA, GERMAN, UKRAINE, ANVISA-Brazil, INVIMA-Colombia, RUSSIA, IRAN, PMDA-Japan, South Korea etc.
Core Technical Skill:
Sterile Injectable dosages form (SVP and LVP ) with liquid and lyophilized form
Qualification & Validation , Computer System Validation, Sterility Assurance, Quality Management System, Risk Management, cGMP training, Failure Investigation , Auditing
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Very department expansion good
The book "300 Questions About Drug Product Manufacturing" on A. did help me a lot!
Thank you sir for giving this brief knowledge 👍
Thanks continue
It was very helpful. Please keep one video on sterilization process and equipment qualifications and sterility package that need to submit in ANDA.
Gracias, greetings from Perú
Have you made any vedio on injectable machines from engineering point of view of totally related to technical issues and maintenance.
Very helpful voor video
Thank you. Please make video in detail of every stage like sterilisation , qualification, validation etc.
Thank you. Can you cover lyophilisation in detail.
Thanks for gist on the injectable manufacturing.Can you share a video on PFS
Thanks palash the easy you explained on injectable manufacturing by stagewise.
Could you keep one video for sterilizations process and Equipment Qualifications as well.
Superb
Explain about compounding total process
Good explanation sir my dout compounding main checking points and critical observation Kya Kya hey mey ipqa mey job karahun
Sir please explain about nitrosamine risk assessment