Industrial methods for product and process development — a case study

1996 ◽  
pp. 475-486 ◽  
Author(s):  
J. Vallhagen
Keyword(s):  
Process Development ◽  
Product And Process

Quality by design case study: An integrated multivariate approach to drug product and process development

2009 ◽  
Vol 382 (1-2) ◽  
pp. 23-32 ◽  
Author(s):  
Jun Huang ◽  
Goldi Kaul ◽  
Chunsheng Cai ◽  
Ramarao Chatlapalli ◽  
Pedro Hernandez-Abad ◽  
...  
Keyword(s):  
Quality By Design ◽  
Process Development ◽  
Drug Product ◽  
Multivariate Approach ◽  
Design Case ◽  
Product And Process ◽  
Design Case Study

scholarly journals An industrial case study: QbD to accelerate time-to-market of a drug product

AAPS Open ◽  
2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Madalena Testas ◽  
Tiago da Cunha Sais ◽  
Leonardo Piccoli Medinilha ◽  
Katia Nami Ito Niwa ◽  
Lucas Sponton de Carvalho ◽  
...  
Keyword(s):  
Process Development ◽  
Drug Product ◽  
Pharmaceutical Products ◽  
Product Knowledge ◽  
Industrial Case Study ◽  
Actual Application ◽  
Product And Process Knowledge ◽  
Product And Process ◽  
Regulatory Flexibility

AbstractThe use of a Quality by Design (QbD) approach in the development of pharmaceutical products is known to bring many advantages to the table, such as increased product and process knowledge, robust manufacturing processes, and regulatory flexibility regarding changes during the commercial phase. However, many companies still adhere to a more traditional pharmaceutical process development—in some cases due to the difficulty of going from a theoretical view of QbD to its actual application. This article presents a real-world case study for the development of an industrial pharmaceutical drug product (oral solid dosage form) using the QbD methodology, demonstrating the activities involved and the gains in obtaining systematic process and product knowledge.

scholarly journals Empirical evaluation of user experience using lean product and process development: A public institution case study in Indonesia

2021 ◽  
Author(s):  
Aang Subiyakto ◽  
Rohadatul Aisy ◽  
Bernadus Gunawan Sudarsono ◽  
Manorang Sihotang ◽  
Didik Setiyadi ◽  
...  
Keyword(s):  
User Experience ◽  
Process Development ◽  
Empirical Evaluation ◽  
Public Institution ◽  
Product And Process

Government Policies and Rural Entrepreneurship- Case Study of an Horticulture Entrepreneur

2016 ◽  
Vol 5 (2) ◽  
Author(s):  
Vinod N. Sambrani
Keyword(s):  
Rural Development ◽  
Rural Areas ◽  
Process Development ◽  
Full Time ◽  
Rural Entrepreneurship ◽  
Development Institutions ◽  
Startup Time ◽  
Nursery Management ◽  
The Government

India is a country which is in forefront of being called a developed nation. To be a developed nation, India has to first look at its rural development, because 70 percent of the population live in rural areas, which means more than 700 million people are spread across 6,27,000 villages. Rural development is more than ever before linked to entrepreneurship. Establishments and agencies promoting rural development now look at entrepreneurship as a strategic development medium that could speed up the rural development process. Development institutions believe that rural entrepreneurship offers a huge potential for employment. In this paper a case study of a young entrepreneur who has taken up horticulture (vegetable plants nursery) as his full time profession, with a mission to help the neighbouring farmers is studied, the purpose of this paper is to understand the government role (policies and schemes), the difficulties faced by the entrepreneur during the startup time and knowledge transfer from the horticulture department, nursery management. The methodology followed is in-depth interaction with the entrepreneur. The outcome of paper will be to understand how rural entrepreneurship is helping improve the quality of life for families, communities and individuals leading to sustainable economy and environment.

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