 |
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: March 2026
Volume 11 | Issue 3
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 : 11
Issue Published : 118
Article Submitted : 21504
Article Published : 8513
Total Authors : 22399
Total Reviewer : 805
Total Countries : 158
Indexing Partner
Licence
This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License
|
Published Paper Details
|
|
| Paper Title: | QUALITY BY DESIGN APPROACH: REGULATORY GUIDELINES AND CURRENT STATUS |
| Authors Name: | Jayesh M. Rajput , Dhanshri S. Nandre , Bhagyashri J. Jayswal |
| Download E-Certificate: | Download |
| Author Reg. ID: |
IJRTI_182577
|
| Published Paper Id: | IJRTI2206165 |
| Published In: | Volume 7 Issue 6, June-2022 |
| DOI: | |
| Abstract: | Quality by design (QbD) is a strategic Process for development and manufacturing. Recently the concept “Quality by Design” gaining much attention among pharmaceutical industries for maintaining quality. The advantage of QbD benefits both the consumer and manufacturer. Some of the QbD elements include quality target product profile (QTPP), CQAs, designing product and manufacturing process, Process parameter and sources of variability. QbD widely promoted by Food and Drug Administration (FDA) and International Conference on Harmonization (ICH). The aim of QbD is to design a quality product and manufacturing process to consistently deliver the intended performance of the product. QbD helps to serve the progressive manufacturing processes, decreases the amount of batch failure, gives more effective control of change and also provide a higher return on investment. In the future, the QbD is going to be accustomed to a far bigger extent. Currently, International Conference on Harmonization is functioning on “ICH- Q13 and ICH- Q14”. This new International Conference on Harmonization tips square measure is expected close to the future. |
| Keywords: | Quality by Design, Regulatory Guidelines |
| Cite Article: | "QUALITY BY DESIGN APPROACH: REGULATORY GUIDELINES AND CURRENT STATUS", International Journal for Research Trends and Innovation (www.ijrti.org), ISSN:2455-2631, Vol.7, Issue 6, page no.1029 - 1035, June-2022, Available :http://www.ijrti.org/papers/IJRTI2206165.pdf |
| Downloads: | 000205264 |
| 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: IJRTI2206165
Registration ID:182577
Published In: Volume 7 Issue 6, June-2022
DOI (Digital Object Identifier):
Page No: 1029 - 1035 Country: Nandurbar, Maharashtra, India Research Area: Pharmacy Publisher : IJ Publication Published Paper URL : https://www.ijrti.org/viewpaperforall?paper=IJRTI2206165 Published Paper PDF: https://www.ijrti.org/papers/IJRTI2206165 |
| 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 © 2026 - All Rights Reserved - IJRTI | |||