QbD Framework – in 2 Minutes (for Scientists)
When I began my QbD journey, I was confused by the jargons that FDA or ICH used (or created) in their guidelines. After some time I understood it. But now I had to explain it to those who are new to Quality by Design. They were unimpressed due to ambiguous terminologies. At the time, my goal was to encourage more process characterization studies. So I translated the QbD framework to fit the lens of my scientist colleagues. It kind of works. So I share.
Quality by Design (QbD) Framework – in plain words (for scientists).
What QbD means to a scientist: This video explains the essence of ICH Q8 (R2) guideline in 2 minutes.
References:
ICH Q8(R2) Presentation from ICH-GCG ASEAN 2010 (Dr, Robert of EMA)
[leadplayer_vid id=”53663BE4AFA7C”]
Transcript:
Let’s begin with the framework; here we have the framework of Quality by Design based on ICH, Q8 Revision 2. It starts with quality target product profiles QTPP and then it translates down to CQA’s; critical quality attributes and then that should be translated to CPP’s; critical process parameters. Now here is where we do a risk assessment and based on the risk assessment you would prioritize mapping out the design space based on high-risk items because you do not have the resources to map every design space, so if very selective about your design space.
And finally, the control strategy is what the manufacturer will do to keep the design space within the ranges that they promised in the monitoring plans and the plans to how to control them, how to change them and so forth. If you look in the scheme of the big things the quality target product profile I will call — Big Y and the CQA; critical quality attributes will be the y and the CPP, which are the critical process parameters I will call the X’s and the design space is where they marry the CQA and the CPP; ultimately to the QTPP’s and so they will be be the function that encompass multiple X’s, that translates to Y’s
So as you can see that the ultimate purpose of the quality by design is to first figure out what we need to focus on and what that relationship is and in this module we’ll focus on the relationship itself. So our ultimate goal is to get that Y equals F(X), to know what the CPP’s are; to know what the CQA’s are and how they relate to each other.
I know it’s not perfect. I’d like to get it down to 1 sentence. I need the community’s help.
Challenge: So how do you explain Quality by Design framework in one sentence?
Comments
Jemin Shah, JOana Ogando Campello like this
32 comments Jump to most recent comment
Sun Kim
Sun Kim
Sr. Manager, Master Black Belt in Quality-by-Design, Agile Lean Six Sigma and Design Thinking
1st attempt: Making better drugs by listening to patients and using best practices? (It didn’t work well…)
Delete 1 month ago
Inna Ben-Anat
Inna
Inna Ben-Anat
Director, Global QbD Strategy and Product Robustness at Teva Pharmaceuticals
Clearly defining what is the intended purpose of the product and then designing this product so it will fit its intended purpose reproducibly throughout its lifecycle…
Unlike Reply privately Flag as inappropriate 1 month ago Sun Kim likes this
Sayeh Majzoob
Sayeh
Sayeh Majzoob
Technology Transfer Manager at Rougine Darou/ Servier/ Krka
Get to know your product and process characteristics and behavior well enough, as to pre-empt letting it slip out of the pre-defined frames (ie Quality standards)! Somehow making your process and product mistake-proof from the early stages of development~ Pokayoke
Like Reply privately Flag as inappropriate 1 month ago
Pushpa Tiwari
Pushpa
Pushpa Tiwari
Assistant Manager at Dr. Reddy’s Laboratories
A systematic and scientific approach for developing a product.
Like (4) Reply privately Flag as inappropriate 1 month ago Imre Molnár, Hanimi Reddy and 2 others like this
Dr. Anindya Basu
Dr. Anindya
Dr. Anindya Basu
Research Fellow at National University of Singapore
It is a systematic method of incorporating all the desired Quality parameters of the target product within the designed
manufacturing process.
Like (1) Reply privately Flag as inappropriate 1 month ago Ravi Kiran Muddha likes this
Ramadas
Ramadas Bhat
Executive QA Director at Isis Pharmaceuticals
A systematic approcah to establishing control strategy for the manufacturing process that gives freedom to operate at defined boundaries outside of the normal ranges with end result being regulatory relief.
Like (2) Reply privately Flag as inappropriate 1 month ago Imre Molnár, Ravi Kiran Muddha like this
pratik chhaparwal
pratik
pratik chhaparwal
Executive at Torrent Pharmaceuticals Ltd.
It is a systematic approach for better understanding of product and process.
Like (1) Reply privately Flag as inappropriate 1 month ago Brooks Henderson likes this
Sun Kim
Sun Kim
Sr. Manager, Master Black Belt in Quality-by-Design, Agile Lean Six Sigma and Design Thinking
Here’s a curve ball: Will a high-school student say, “I get it!” after hearing the pitch?
So far, these are good. Can we have 10 more? Thanks!
Delete 1 month ago
Kwang-Min Lee
Kwang-Min
Kwang-Min Lee
Process Scientist at Celltrion
Calibrating process, product, & patient with quantified methods
Like Reply privately Flag as inappropriate 1 month ago
A K M Hai
A K M
A K M Hai
Chief Scientific Officer at MOLESCI & MATESCI INC
The effectiveness or efficacy of the drug product was achieved and reproducible consistently by controlling the quality of the process parameter and thus design by quality.Thanks
Like Reply privately Flag as inappropriate 1 month ago
Imre Molnár
Imre
Imre Molnár
President of Molnar-Institute
ObD is the end of trial&error, it is based on a planned Design of Experiments (DoE), risk- and robustness evaluation, that gives freedom to operate inside of multivariable Design Space with the end result to obtain much more flexibility to change working conditions as in the past and at the same time reducing regulatory oversight to a minimum.
Like (2) Reply privately Flag as inappropriate 1 month ago Yogesh G., Lisel V. like this
Bhagyesh Trivedi
Bhagyesh
Bhagyesh Trivedi
Senior Research Officer at Glenmark Generics Ltd.
Three words…Predefined goal sound science good risk assessment=QbD
Unlike Reply privately Flag as inappropriate 1 month ago Parth Patel, Pushpa Tiwari and 1 other like this
Samir Shah
Samir
Samir Shah
Manager at Sun Pharmaceutical Industries Limited, Mumabi
QbD can be defined as “To achieve the quality of product by working within predefined parameters (design space)”
Like Reply privately Flag as inappropriate 1 month ago
Dr. Kishor Kumar Chakraborty
Dr. Kishor Kumar
Dr. Kishor Kumar Chakraborty
Head – R&D & Regulatory file preparation at Riyadhpharma,Riyadh
Systematic approach for development and manufacturing of products.
Like Reply privately Flag as inappropriate 1 month ago
Balaji Somwanshi
Balaji
Balaji Somwanshi
Executive in Regulatory Affairs at Wockhardt
“Establishing quality in the drug product with scientifically defined studies for formulation variables and process variables control”.
Like Reply privately Flag as inappropriate 27 days ago
Larry
Larry Wilson
Owner, Mariner Analytical LLC
For those ‘not in the industry’: you might explain that while raw materials fed into a drug/ dose manufacturing process will vary – sometimes widely – if the critical quality attributes of the raw materials and the critcal parameters of the process (manufacturing/ packaging, ,,,) are well understood, then it’s possible to write process directions that yield product having consistent quality.
Like Reply privately Flag as inappropriate 26 days ago
venkateswarlu vobalaboina
venkateswarlu
venkateswarlu vobalaboina
Managing Director, NEUHEIT PHARMA TECHNOLOGIES PVT LTD
Quality by Design is a philosophy based on the concept “quality has to be built in not tested for”.
Like Reply privately Flag as inappropriate 26 days ago
Kamalakar Rao Nukala
Kamalakar Rao
Kamalakar Rao Nukala
General Manager- Pharmaceutical Formulation Development with a JCBL Group company
Quality by Design: This is not a new word. It is there in other industries since I think 1900. Everybody who works always strives for Quality. During this process every body uses the technology, Engineering and Science. That is basics of Statistics, Design and mathematics.
It all depends on available time to do experiment, cost of API and urgency to enter the market. How well you design still we will struggle for quality.
Hence, Quality by design is a dynamic word which requires in every stage of product life cycle and challenging.
Like Reply privately Flag as inappropriate 26 days ago
A K M Hai
A K M
A K M Hai
Chief Scientific Officer at MOLESCI & MATESCI INC
Designing and developing formulations and manufacturing processes to ensure predefined product quality
Like Reply privately Flag as inappropriate 25 days ago
Bhagyesh Trivedi
Bhagyesh
Bhagyesh Trivedi
Senior Research Officer at Glenmark Generics Ltd.
An approach which designs new inherently efficient systems which requires an integration of systems understanding, techniques, and domain knowledge.
Like Reply privately Flag as inappropriate 23 days ago
kiran
kiran orugonda
Formulation Scientist at Hetero Drugs Ltd
QbyD is to develop a product with all acceptable formulation and process parameters in order to ensure the quality with out affecting the effecacy and safty of dosage form
Like Reply privately Flag as inappropriate 21 days ago
Rajiv
Rajiv Modha
Director QA/QC at Goodwin Biotechnology Inc
Designing new products, or manufacturing processes following a deliberate, science-based, and well-documented approach that seeks to gain a thorough understanding about the product and the manufacturing process, which, in turn, leads to high quality products that can be manufactured day-in, day-out.
Like Reply privately Flag as inappropriate 20 days ago
Hemant Kumar Bankhede
Hemant Kumar
Hemant Kumar Bankhede
Formulation Center of Excellence – Senior Scientist
QbD
Is a concept of
Quality= Safe, efficacious, stable product development
by
Design= Understanding and controlling product (Drug+excipient), Process (manufacturing process variable)
Like Reply privately Flag as inappropriate 19 days ago
Peter Chan
Peter
Peter Chan
Quality Compliance Specialist
The design that gives you flexibility to manage the process parameters changes without compromising the quality of the product.
Like (1) Reply privately Flag as inappropriate 18 days ago Kishore Gottumukkala likes this
Mahsa Yazdani
Mahsa
Mahsa Yazdani
Responsible Pharmacist at Tabiat Zendeh CINERE
Designing and developing of formulation and manufacturing process to ensure consistently predefined quality by understanding how formulation and manufacturing process variables influences the quality of product.
Like Reply privately Flag as inappropriate 17 days ago
Jemin
Jemin Shah
Working as Regulatory professional in F&D-RA department at Bharat Parenterals Ltd.
QbD means designing the parameter which affect during achievment of the predefined product characteristics by developing desired quality in the final product.
Unlike Reply privately Flag as inappropriate 16 days ago Sun Kim likes this
Bharathi Kodali
Bharathi
Bharathi Kodali
Scientist – Regulatory Affairs
QbD = Quality Input is proportional to the Quality Output
Like Reply privately Flag as inappropriate 15 days ago
Sarasija
Sarasija Suresh
Department of Pharmaceutical Technology (Fomulation)
Experiments to develop effective medicine
Like Reply privately Flag as inappropriate 14 days ago
Harikrishna Tumma Ph. D.
Harikrishna
Harikrishna Tumma Ph. D.
Process Development, Technology Transfer, Life Cycle Management, DoE, QbD, QRA, PAT, Process Design
QbD is an incremental build-up of process understanding throughout development assuring Critical Quality Attributes (CQAs) of the drug substance or drug product using a multivariate experimental approach.
QbD is an EVOLUTION, not a REVOLUTION, in the approach that take to the development of an efficient manufacturing process.
Like Reply privately Flag as inappropriate 14 days ago
Sonu Dalsania
Sonu
Sonu Dalsania
Student at NIPER Mohali
QbD is an approach to incorporate the quality attributes during product designing with a complete process and product understanding, rather than testing the product for quality after designing it.
Like Reply privately Flag as inappropriate 14 days ago
Arun Tandon
Arun
Arun Tandon
Executive- Packing & Process Excellence
QbD is to ensure the quality of the products at various stages of the product manufacturing. To ensure the manufactured product meets to all quality parameters and safe for human being in all aspects.
Like Reply privately Flag as inappropriate 13 days ago
Minhaj Patel
Minhaj
Minhaj Patel
Global Category Quality Manager at Reckitt Benckiser (Thailand)
To me, QbD is a risk management tool, which allows you to better understand the products and its associated processes. Its a tool which allows ‘Quality’ control throughout the entire production process to minimise/eliminate batch rejections at the point of end-product testing for release, which then has direct impact on cost. At the end of day, businesses want to save on cost and QbD, if implemented correctly, can help achieve this.
Like Reply privately Flag as inappropriate 13 days ago