 |
International Journal for Research Trends and Innovation
International Peer Reviewed & Refereed Journals, Open Access Journal
ISSN Approved Journal No: 2456-3315 | Impact factor: 8.14 | ESTD Year: 2016
Scholarly open access journals, Peer-reviewed, and Refereed Journals, Impact factor 8.14 (Calculate by google scholar and Semantic Scholar | AI-Powered Research Tool) , Multidisciplinary, Monthly, Indexing in all major database & Metadata, Citation Generator, Digital Object Identifier(DOI)
|
Issue: December 2025
Volume 10 | Issue 12
Review Result and Publication of Paper within : 2-3 days
Click Here For more DetailsFor Authors
Forms / Download
Published Issue Details
Editorial Board
Other IMP Links
Facts & Figure
Impact Factor : 8.14
Issue per Year : 12
Volume Published : 10
Issue Published : 115
Article Submitted : 19456
Article Published : 8041
Total Authors : 21252
Total Reviewer : 769
Total Countries : 144
Indexing Partner
Licence
This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License
|
Published Paper Details
|
|
| Paper Title: | Design of Technology Transfer of Drug Product From R&D To Manufacturing Site And Manufacturing Site To Manufacturing Site |
| Authors Name: | Abhishek Borkar , Ganesh Bahekar , Ravikumar More , Shubhada bhopale |
| Download E-Certificate: | Download |
| Author Reg. ID: |
IJRTI_187758
|
| Published Paper Id: | IJRTI2308003 |
| Published In: | Volume 8 Issue 8, August-2023 |
| DOI: | |
| Abstract: | Abstract: In recent years, there is a growing awareness that an appropriate transfer of manufacturing technologies (technology transfer) is important to upgrade drug quality as designed during R&D to be a final product during manufacture as well as assure stable quality transferred for many reasons between contract giver and contract acceptor during manufacture. The drug quality, it is desired to make sure 5 W’s and 1 H, that is what, when and why information should be transferred to where and by whom and how to transfer, then share knowledge and information of the technology transfer each other between stake holders related to drug manufacturing. Transfer of Technology (TT) is defined as “a logical procedure that controls the transfer of an established process together with its documentation and professional expertise to a site capable of reproducing the process and its support functions to a predetermined level of performance. In most cases, scale-up occurs in several stages. Small-scale laboratory development from 0.5 to 2 kg can be scaled up to 5-10 kg and then 20-100 kg on a pilot scale. Production scale can typically range from 200 kg to greater than 1000 kg. The ultimate goal for any product as it advances through development is to produce a formulation and a process that will be robust enough for routine commercial manufacture. Technology transfer contributes Quality-by-Design (QbD) principles by identifying critical quality attributes, the key manufacturing parameters that affect those attributes, and ways to control those manufacturing parameters which has its own set of challenges. The development of a robust formulation and process thr |
| Keywords: | Transfer of Technology, Quality-by-Design |
| Cite Article: | "Design of Technology Transfer of Drug Product From R&D To Manufacturing Site And Manufacturing Site To Manufacturing Site", International Journal of Science & Engineering Development Research (www.ijrti.org), ISSN:2455-2631, Vol.8, Issue 8, page no.5 - 12, August-2023, Available :http://www.ijrti.org/papers/IJRTI2308003.pdf |
| Downloads: | 000205265 |
| ISSN: |
2456-3315 | IMPACT FACTOR: 8.14 Calculated By Google Scholar| ESTD YEAR: 2016 An International Scholarly Open Access Journal, Peer-Reviewed, Refereed Journal Impact Factor 8.14 Calculate by Google Scholar and Semantic Scholar | AI-Powered Research Tool, Multidisciplinary, Monthly, Multilanguage Journal Indexing in All Major Database & Metadata, Citation Generator |
| Publication Details: |
Published Paper ID: IJRTI2308003
Registration ID:187758
Published In: Volume 8 Issue 8, August-2023
DOI (Digital Object Identifier):
Page No: 5 - 12 Country: Washim, Maharashtra , India Research Area: Pharmacy Publisher : IJ Publication Published Paper URL : https://www.ijrti.org/viewpaperforall?paper=IJRTI2308003 Published Paper PDF: https://www.ijrti.org/papers/IJRTI2308003 |
| Share Article: | |
|
Click Here to Download This Article |
|
| Article Preview | |
|
|
|
Major Indexing from www.ijrti.org
| Google Scholar | ResearcherID Thomson Reuters | Mendeley : reference manager | Academia.edu |
| arXiv.org : cornell university library | Research Gate | CiteSeerX | DOAJ : Directory of Open Access Journals |
| DRJI | Index Copernicus International | Scribd | DocStoc |
ISSN Details
 |
 |
|
ISSN: 2456-3315
Impact Factor: 8.14 and ISSN APPROVED,
Journal Starting Year (ESTD) : 2016
DOI (A digital object identifier)
| Providing A digital object identifier by DOI.ONE How to Get DOI? |
Conference
Open Access License Policy
This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License
Important Details
Join RMS/Earn 300
WhatsApp
Click Here
Click Here
Indexing Partner |
|||
| Copyright © 2025 - All Rights Reserved - IJRTI | |||