Quality by design approach: Regulatory need
In this era of competition quality has been given prime magnitude; failure to meet such quality allied goals produces massive shift of company in share of market. In this context pharmaceutical industry is utmost regulated industry as it is governed by authoritative regulatory bodies. “Quality could...
| Main Authors: | , , , , |
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| Format: | Article |
| Language: | English |
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Elsevier
2017-05-01
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| Series: | Arabian Journal of Chemistry |
| Subjects: | |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S1878535214000288 |
| _version_ | 1818901077919006720 |
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| author | Jaiprakash N. Sangshetti Mrinmayee Deshpande Zahid Zaheer Devanand B. Shinde Rohidas Arote |
| author_facet | Jaiprakash N. Sangshetti Mrinmayee Deshpande Zahid Zaheer Devanand B. Shinde Rohidas Arote |
| author_sort | Jaiprakash N. Sangshetti |
| collection | DOAJ |
| description | In this era of competition quality has been given prime magnitude; failure to meet such quality allied goals produces massive shift of company in share of market. In this context pharmaceutical industry is utmost regulated industry as it is governed by authoritative regulatory bodies. “Quality could be planned and most of quality deficit arises in the way process is planned and developed”, this thought of well known quality expert Joseph Moses Juran gives foundation to the concept of quality by design (QbD). USFDA launched a pilot programme in 2005 to permit participating firms a prospect to submit chemistry, manufacturing, and controls (CMC) of NDA information representing application of QbD. Now USFDA is accelerating QbD drive by making warning to generic manufacturers from January 2013. QbD has its perspectives to contribute the drug design, development, and manufacture of high-quality drug products. In the present review basic consideration of the QbD approach, its historical background, and regulatory needs are discussed. In detail explanation of elements of QbD i.e. method intent, design of experiment, and risk assessment is given. Application of QbD to pharmaceutical and biopharmaceutical processes, development and unit operation associated with it are briefly mentioned. Detail account of QbD to analytical technique is explained thoroughly by referencing examples. |
| first_indexed | 2024-12-19T20:14:02Z |
| format | Article |
| id | doaj.art-b99ed08685824fb88c8a45f3385e1757 |
| institution | Directory Open Access Journal |
| issn | 1878-5352 |
| language | English |
| last_indexed | 2024-12-19T20:14:02Z |
| publishDate | 2017-05-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Arabian Journal of Chemistry |
| spelling | doaj.art-b99ed08685824fb88c8a45f3385e17572022-12-21T20:07:14ZengElsevierArabian Journal of Chemistry1878-53522017-05-0110S2S3412S342510.1016/j.arabjc.2014.01.025Quality by design approach: Regulatory needJaiprakash N. Sangshetti0Mrinmayee Deshpande1Zahid Zaheer2Devanand B. Shinde3Rohidas Arote4Y. B. Chavan College of Pharmacy, Dr. Rafiq Zakaria Campus, Rauza Baugh, Aurangabad 431001, IndiaY. B. Chavan College of Pharmacy, Dr. Rafiq Zakaria Campus, Rauza Baugh, Aurangabad 431001, IndiaY. B. Chavan College of Pharmacy, Dr. Rafiq Zakaria Campus, Rauza Baugh, Aurangabad 431001, IndiaDepartment of Chemical Technology, Dr. B. A. M. University, Aurangabad 431004, IndiaDepartment of Molecular Genetics, School of Dentistry, Seoul National University, Seoul, Republic of KoreaIn this era of competition quality has been given prime magnitude; failure to meet such quality allied goals produces massive shift of company in share of market. In this context pharmaceutical industry is utmost regulated industry as it is governed by authoritative regulatory bodies. “Quality could be planned and most of quality deficit arises in the way process is planned and developed”, this thought of well known quality expert Joseph Moses Juran gives foundation to the concept of quality by design (QbD). USFDA launched a pilot programme in 2005 to permit participating firms a prospect to submit chemistry, manufacturing, and controls (CMC) of NDA information representing application of QbD. Now USFDA is accelerating QbD drive by making warning to generic manufacturers from January 2013. QbD has its perspectives to contribute the drug design, development, and manufacture of high-quality drug products. In the present review basic consideration of the QbD approach, its historical background, and regulatory needs are discussed. In detail explanation of elements of QbD i.e. method intent, design of experiment, and risk assessment is given. Application of QbD to pharmaceutical and biopharmaceutical processes, development and unit operation associated with it are briefly mentioned. Detail account of QbD to analytical technique is explained thoroughly by referencing examples.http://www.sciencedirect.com/science/article/pii/S1878535214000288Quality by design (QbD)USFDAAnalytical techniquesDesign of experimentRisk assessment |
| spellingShingle | Jaiprakash N. Sangshetti Mrinmayee Deshpande Zahid Zaheer Devanand B. Shinde Rohidas Arote Quality by design approach: Regulatory need Arabian Journal of Chemistry Quality by design (QbD) USFDA Analytical techniques Design of experiment Risk assessment |
| title | Quality by design approach: Regulatory need |
| title_full | Quality by design approach: Regulatory need |
| title_fullStr | Quality by design approach: Regulatory need |
| title_full_unstemmed | Quality by design approach: Regulatory need |
| title_short | Quality by design approach: Regulatory need |
| title_sort | quality by design approach regulatory need |
| topic | Quality by design (QbD) USFDA Analytical techniques Design of experiment Risk assessment |
| url | http://www.sciencedirect.com/science/article/pii/S1878535214000288 |
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