Quality-by-Design (QbD)
In 2006, Merck & Co.’s Januvia became the first product approved based upon QbD application. Importance of QbD and QbR (Question based review) today are the success mantra for product approvals with regulatory agencies.
FDA's QbD imperative is best outlined in its report “Pharmaceutical Quality for the 21st Century: A Risk-Based Approach.
In the past few years, the agency has made significant progress in implementing the concepts of "Quality by Design" (QbD) into its pre-market processes. The focus of this concept is that quality should be built into a product with a thorough understanding of the product and process by which it is developed and manufactured along with a knowledge of the risks involved in manufacturing the product and how best to mitigate those risks. This is a successor to the "quality by QC" (or
"quality after design") approach that the companies have taken up until 1990s.
The QbD initiative, which originated from the Office of Biotechnology Products (OBP), attempts to provide guidance on pharmaceutical development to facilitate design of products & processes that maximizes the product’s efficacy and safety profile while enhancing product manufacturability.
Fundamental to this initiative is the understanding of the relationship between the quality attributes of the product (physicochemical and biological properties) and their impact on the safety and efficacy. This requires knowledge of the relationship between structure and biological
functions.
FDA's QbD imperative is best outlined in its report “Pharmaceutical Quality for the 21st Century: A Risk-Based Approach.
In the past few years, the agency has made significant progress in implementing the concepts of "Quality by Design" (QbD) into its pre-market processes. The focus of this concept is that quality should be built into a product with a thorough understanding of the product and process by which it is developed and manufactured along with a knowledge of the risks involved in manufacturing the product and how best to mitigate those risks. This is a successor to the "quality by QC" (or
"quality after design") approach that the companies have taken up until 1990s.
The QbD initiative, which originated from the Office of Biotechnology Products (OBP), attempts to provide guidance on pharmaceutical development to facilitate design of products & processes that maximizes the product’s efficacy and safety profile while enhancing product manufacturability.
Fundamental to this initiative is the understanding of the relationship between the quality attributes of the product (physicochemical and biological properties) and their impact on the safety and efficacy. This requires knowledge of the relationship between structure and biological
functions.
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Innoworks's team of experts have five decades of collective experience in quality management and compliance audits spanning over a wide spectrum of industries.
We offers Due diligence and cGxP (cGMP, cGLP and cGCP) auditing solutions for-
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Our Clientale companies
- Pharmaceutical
- Bio- Medical devices.
- OTC.
- Neutraceuticals.
- Biotechnology.
- Foods.
- Cosmetics.
- FMCG goods / Consumer Goods.
RISK ASSESSMENT
Innoworks Drug Product Development Risk Assessment Scorecard is a quantitative tool and rate chart, specially designed to improve efficiency and reduce potential risk of revenues in drug development programs of small and big Pharma, FMCG, Neutraceutical and Biotechnology companies.
Our Risk assessment score card is a project manager's dashboard i.e. it not only identifies and mitigates risks but also provides remedial solution to project managers in achieving their goals.
Risk analysis service overview -
- Risk analysis during selection of compound.
- Risk analysis during identification of lab scale lead prototype.
- Risk analysis during selection of manufacturing facility and equipment.
- Risk analysis for successful transfer of technology to alternate or multiple sites.
- Risk analysis during selection of alternate vendors for excipients, pack materials and api.
- Risk analysis during selection of prorotype for successful pilot and pivotal Bio-availability/ Bio-equivalence studies.
- Risk analysis during technology, brand or facility acquisition.
- Risk analysis during design of start-up R&D lab or manufacturing site.
Innowork’s Scorecard is based on evaluations of different drug candidates (and operating processes) by its scientists over many years.
*For further information on Innoworks’s Drug Product Development Risk Assessment Scorecard, or for help scoring products in development, contact Innoworks's Front desk.