alexa Regulatory Approach to Ensure Quality of Products - An Indian Perspective of Missing Linkage
ISSN: 2167-7689

Pharmaceutical Regulatory Affairs: Open Access
Open Access

OMICS International organises 3000+ Global Conferenceseries Events every year across USA, Europe & Asia with support from 1000 more scientific Societies and Publishes 700+ Open Access Journals which contains over 50000 eminent personalities, reputed scientists as editorial board members.

Open Access Journals gaining more Readers and Citations

700 Journals and 15,000,000 Readers Each Journal is getting 25,000+ Readers

This Readership is 10 times more when compared to other Subscription Journals (Source: Google Analytics)

Research Article

Regulatory Approach to Ensure Quality of Products - An Indian Perspective of Missing Linkage

Kumar N* and Jha A

Sikkim Manipal Institute of Technology, Majitar, Rangpo, Sikkim 737132, India

*Corresponding Author:

Kumar N
Sikkim Manipal Institute of Technology
Majitar, Rangpo, Sikkim 737132, India
Tel: +919951970829
E-mail: [email protected]

Received Date: March 23, 2016; Accepted Date: May 09, 2016; Published Date: May 11, 2016

Citation: Kumar N, Jha A (2016) Regulatory Approach to Ensure Quality of Products-An Indian Perspective of Missing Linkage. Pharmaceut Reg Affairs 5:163. doi:10.4172/2167-7689.1000163

Copyright: © 2016 Kumar N, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.



The objective of the study is to assess the Indian perspective of nourishment through regulatory guidelines for quality system prescribed during manufacturing operations managed at plant level and distribution managed by supply chain management beyond manufacturing premises. Good Manufacturing Practices (GMP) and Good distribution Practices (GDP) are two prominent regulatory guidelines available to manage them within plant and outside plant respectively. Method: The method study shall be exploratory studies based on data and facts derived from government organizations, regulatory bodies and scholarly literatures available on the subject matter. Indian government has reinforced the sampling of market samples for analysis in order to assess their quality. The product sample analysis results by CDSCO of Government of India has been analyzed to estimate the types of quality defects, in addition to making use of information from relevant literatures. Results: The review of existing legislations available to directly or indirectly manage quality of pharmaceutical products, it is found that regulations are more centered towards the manufacturing operation, if quality is taken into consideration. There is need to maintain the overall quality of products by taking care during manufacturing process as well as during distribution operations, hence the linkage between regulatory guidance for these two operations must be established effectively. Conclusion: The existing design of system is discrete with respect to management of quality during manufacturing and distribution operations for pharmaceutical products. Regulatory bodies are recommended to reinforce the effective linkage in regulations for manufacturing and distribution system through working paper, technical report series and or regulatory guidance.


Share This Page

Additional Info

Loading Please wait..
Peer Reviewed Journals
Make the best use of Scientific Research and information from our 700 + peer reviewed, Open Access Journals
International Conferences 2017-18
Meet Inspiring Speakers and Experts at our 3000+ Global Annual Meetings

Contact Us

Agri, Food, Aqua and Veterinary Science Journals

Dr. Krish

[email protected]

1-702-714-7001 Extn: 9040

Clinical and Biochemistry Journals

Datta A

[email protected]

1-702-714-7001Extn: 9037

Business & Management Journals


[email protected]

1-702-714-7001Extn: 9042

Chemical Engineering and Chemistry Journals

Gabriel Shaw

[email protected]

1-702-714-7001 Extn: 9040

Earth & Environmental Sciences

Katie Wilson

[email protected]

1-702-714-7001Extn: 9042

Engineering Journals

James Franklin

enginee[email protected]

1-702-714-7001Extn: 9042

General Science and Health care Journals

Andrea Jason

[email protected]

1-702-714-7001Extn: 9043

Genetics and Molecular Biology Journals

Anna Melissa

[email protected]

1-702-714-7001 Extn: 9006

Immunology & Microbiology Journals

David Gorantl

[email protected]

1-702-714-7001Extn: 9014

Informatics Journals

Stephanie Skinner

[email protected]

1-702-714-7001Extn: 9039

Material Sciences Journals

Rachle Green

[email protected]

1-702-714-7001Extn: 9039

Mathematics and Physics Journals

Jim Willison

[email protected]

1-702-714-7001 Extn: 9042

Medical Journals

Nimmi Anna

[email protected]

1-702-714-7001 Extn: 9038

Neuroscience & Psychology Journals

Nathan T

[email protected]

1-702-714-7001Extn: 9041

Pharmaceutical Sciences Journals

John Behannon

[email protected]

1-702-714-7001Extn: 9007

Social & Political Science Journals

Steve Harry

[email protected]

1-702-714-7001 Extn: 9042

© 2008-2017 OMICS International - Open Access Publisher. Best viewed in Mozilla Firefox | Google Chrome | Above IE 7.0 version