Process AnAlyticAl technologies (PAt) And QuAlity by design (Qbd)

overview

2014

www.PAtAndQbd.com

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contents

introduction3

Key benefits of PAt And Qbd imPlementAtion4

3 Key trends in PAt / Qbd imPlementAtion6

best PrActice wAys to overcome common chAllenges in PAt7

imProving PAt vAlidAtion8

chAnges in PAt And Qbd investment And imPlementAtion inforgrAPhic9

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introduction

yet 72%do not hAve A fully estAblished Process in PlAce.

80%of comPAnies PlAn to invest in QuAlity by design And PAt solutions,

vbut whAt is the reAson for this gAP?c

59%of PeoPle stAted it wAs due to internAl lAcK of exPertise.

For the past 11 years, Pharma IQ’s PAT & Quality By Design conference has been bringing you the latest case studies to help show you the benefits of PAT and QbD and how to effectively implement QbD into your company. This year in conjunction with Pharma IQ we have brought together insights from leading experts in the field.

In this eBook we explore 3 key trends in implementation, how to make a business case for PAT and QbD implementation and best practice ways to overcome common challenges in PAT.

We hope you enjoy reading. Best regards

Andrea Charles Editor Pharma IQ www.pharma-iq.com

www.PAtAndQbd.com

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Key benefits of PAt And Qbd imPlementAtion

brett cooPer reseArch fellow, msd develoPment lAborAtories, tAlKs to PhArmA iQ, About the slower thAn AnticiPAted industry uPtAKe of PAt And Qbd, the Key benefits of PAt And Qbd imPlementAtion And the biggest chAllenge PhArmA And bio comPAnies fAce regArding the interPretAtion of regulAtory guidAnce. cooPer Also discusses how to Prove the business cAse for PAt And Qbd imPlementAtion. to listen to the interview in full mAKing A business cAse for PAt And Qbd imPlementAtion:

PhArmA iQ:The SPA driven PAT and QbD initiative was launched almost ten years ago but there still remains a substantial sector of the market that are not using PAT or QbD methods. Although companies undoubtedly have much better understanding of what QbD is we still do not see many initiatives taking place across the pharma industry. Why do you think the industry uptake has been slower t han originally anticipated by the FDA?

PhArmA iQ:And what do you think is the biggest challenge pharma and bio companies face with regard to interpretation of regulatory guidance?

b cooPer:I can think from the Merck point of view that I guess once the FDA announced the QbD initiatives and it started working on it almost straight away. And I think that Merck introduced QbD into one of its projects as part of the trial that was going ahead initially. QbD in that respect was sort of jumped into by Merck to some degree. Although I guess the big pharma companies such as Merck, there obviously is some degree of alignment that needs to take place before companies like that can implement QbD throughout a project and assess the impact of that. So I guess things like management position on taking a stance on the

recommendations and then teams being formed to work out how we’re going to implement those sorts of procedures. And I guess the downstream training and implementation of those processes with the majority of staff in a large company will take time. And I guess at least on a Merck perspective we try to implement those processes as quickly as possible. And then there’s also the impact of the development time lines that need to be considered. So if you start with a new project and start implementing QbD those projects can take considerable time to get to the market or get to review by the FDA.

b cooPer:In terms of regulatory guidance I guess that their challenge would be more around the resource to investigate that because a lot of those companies will be smaller. For pharma and bio companies especially, reading into the guidelines and determining how to understand those may be more problematic for the smaller companies. But the larger companies I guess coming to an

agreement and discussing the guidance with the regulatory authorities is another thing that needs to occur. Sometimes I guess the big industries, when we come to follow the guidances and present those in a filing there can often be some aspects which are seen as different by the FDA. It depends on how the interpretation is set.

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Key benefits of PAt And Qbd imPlementAtion

PhArmA iQ: What are the key benefits of PAT and QbD implementation?

http://www.pharma-iq.com/pre-clinical-discovery-and-development/articles/key-benefits-of-pat-and-qbd-implementation/

b cooPer:QbD obviously is designed to give you the flexibility to change downstream. So if you can demonstrate that you have a wide working margin then you can maybe find ways to optimise and improve your process downstream while remaining within the QbD space that you’ve designed. PAT is a pretty powerful tool and if you

link that with your processing machinery then you can actually monitor the process. Maybe come up with real time release of the process to cut down on the amount of testing downstream and also really link the PAT with the process to ensure the quality of the material is optimised at the end.

b cooPer:I guess by trial and implementation of those processes and then evaluating how those processes have gone. I guess the bigger companies where when you have multiple projects going forward and you start implementing your PAT and QbD processes and you start comparing those with prior processes you can sort of track how things are going and how the costs can be potentially reduced. Some

procedures where you implement QbD strategies or designs or procedures that are already in place where there are maybe some issues or batches that potentially aren’t processing so well, you can almost see an immediate change if you track the processes during the manufacture. So there’s sometimes an immediate win by implementing those processes that can be achieved.

PhArmA iQ:How do you think companies can improve the business case for PAT and QbD implementation?

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3 Key trends in PAt / Qbd imPlementAtion

in 2013 Peter boogAArd, founder of industriAl lAb AutomAtion And director At viAlis Ag gAve A worKshoP At the 10th AnniversAry PAt & QuAlity by design conference. he gives An overview of the toP tAKeAwAys from the event.lAst yeAr’s ProgrAm included mAny cAse studies And generAl trends in the Qbd And PAt AdoPtion, but there were three PArticulAr toPics thAt triggered his Attention.

Driving the need for constant product innovations in a legislation-complex industry remains a challenge in the life sciences industry. Quality should be built into the design throughout the specification, design and verification process. The consumer demand becomes more sophisticated, in both the innovative pharma and generics side if the industry. During breakout discussions at the conference, it was obvious that the drivers

for both pharma segments are different. The traditional pharma industry is focusing on new product innovation while the generic industry is concentrating on optimizing production to reduce costs with manageable predictive quality. It seems implementing QbD within the generic industry has many similarities with other industries such as consumer packaged goods and electronics.

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It may seem a boring topic these days, but the need for standardisation in our industry has never been higher. Forums like this conference presents a valuable opportunity for so many people from different regions, job functions and seniority to come together to discuss how the industry can evolve these and make it happen. Both John Purves, former head of EMA and Lawrence Yu, Deputy Director of the

FDA, presented the notion that regulators are more familiar with QbD than some years ago. Instead of discussion “why QbD”, the focus was centred on “how can we make it happen”. A point of attention was raised for standardisation in nomenclature and naming convention to avoid miscommunication across industry and regulators.

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The term QbD and PAT are becoming mainstream in our industry, however recent research from Pharma IQ showed that 68% of individuals surveyed are in the early stages of implementing QbD and lack the expertise to fully implement into all processes. Quality should be built into the design throughout the specification, design,

and verification process. There is still a lot of education to be done across the different disciplines within organizations. The ICH Q10 guidelines clearly defines that a modern quality system assures science and risk-based drug manufacturing and quality decisions throughout the lifecycle.

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http://www.pharma-iq.com/manufacturing/articles/3-key-trends-in-pat-qbd-implementation/

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best PrActice wAys to overcome common

chAllenges in PAtrAKhi bAj, technicAl Project leAder At Abbott diAgnostics, joins PhArmA iQ to offer some best PrActice wAys to overcome common chAllenges in PAt. to listen to the PodcAst now go to inside tiPs on mAKing Progress in PAt.

PhArmA iQ:What do you think are the major challenges that hinder the progress of increased process understanding and control?

PhArmA iQ:So, expanding on this, do these challenges differ when working in the diagnostics field, and if so, how?

PhArmA iQ:Finally, what are the key tools and techniques that you personally find the most effective in your work?

One of the key challenges that I come across quite often is a lack of understanding of the actual tools. People are inherently wary of mathematics and statistics and they get the perception that they’re really difficult and that really it should be left up to the statisticians to work away in the corner and come up with the answer. But I think both scientists and statisticians need to work together to get a

better understanding of the process; what are the issues; where are the bottlenecks, and then decide on the best approach. I think it’s really important for statisticians to get a better understanding of the process and for scientists to get a better understanding of statistics, and that way the two groups can decide on the best tools to use for that specific area.

r bAj

Not really. The challenges stay the same, but the processes are different, but I do believe that with increased communication and working across

the functional groups, a better understanding of the process can be achieved, and therefore better control.

r bAj

In terms of the statistics tools we use a lot of control charts and host capability type tools and indices, and in terms of the non-stats tools, things like process flow diagrams and Ishikawa

fishbone diagrams work really well. We’re big fans of fast jump and mini tab as well in terms of statistical software packages and we use them quite a lot in everyday activities.

r bAj

http://www.pharma-iq.com/manufacturing/articles/best-practice-ways-to-overcome-common-challenges-i/

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imProving PAt vAlidAtion

Warman also shares his insights on

how to select the right partner in the validation process.

Martin Warman, Scientific Fellow, Analytical

Development at Vertex Pharmaceuticals, joins

Andrea Charles from Pharma IQ, to discuss the effects of

apply PAT to pharmaceutical manufacturing and how to successfully validate PAT

methods.

QuAlificAtion of eQuiPment And vAlidAtion

of AnAlyticAl methods Are criticAl comPonents for the imPlementAtion of Process AnAlyticAl

technology (PAt).

listen to mArtins’ PodcAst here

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18th - 20th March 2013, London, UK

www.patandqbd.com

80% said they plan to invest in Quality by Design and PAT solutions. With budgets being cut and margins becoming tighter, QbD and PAT are becoming more and more critical for the pharmaceutical industry. In preparation for the 10th Annual PAT and QbD conference, Pharma IQ has analysed the change in investment levels over the last 3 years.

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62% say they use conferences and events to find out about solutions

and services in this space:

18th-20th March 2013 London, UK

www.patandqbd.com

88% believe QbD practices will become mandatory in the innovative pharma industry as it has done with generics

Changes in of QbD and PAT implementation over the last 3 years

% of those planning to invest in QbD and PAT in the next 12 months

What are the key reasons for not

implementing QbD?

No plans for implementation

Interested in learning more but not done yet

In early stages of implementation

Established QbD implementation

2011 44%

2012 80%

Knowledge and expertise in the field of QbD is up 13% since 2011

In 2011, 42% said theability to demonstrate ROI was the biggest barrier to investing in QbD and PAT solutions

In 2012, the main solutions that end-users invested in were:

Changes in Investment and Implementation: 2010-2012

PAT hardware 34%

QbD software 15%

QbD expertise and consultants 30%

Data management solutions 21%

50% say lack of knowledge and expertise isthe biggest reason for not implementing QbD

2010

2011

2012

42% ability to demonstrate ROI

40% integration with current practices

59% lack of internal expertise

34%

32%

21%

13%

2010

5%

25%

50%

20%

2011

5%

14%

53%

28%

2012

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mAximise cost efficiency, imProve QuAlity And cut wAste through QuAlity by design

24 - 25 mArch, 2014 - london, uK

Key toPics include:

vWhat the regulators expect from filings and how this can be achieved, with key updates on current regulatory requirements along with results from the latest FDA/EMA parallel pilot study

vHow to implement the most effective QbD process in order to maximise profit and case studies from leaders in the industry on how this has been done

vThe future of QbD in Biologics: overcoming the problems of heterogeneity and data variation

vThe implementation of QbD in the generic industry: how the industry are coping with the mandatory requirement

vLatest advances in PAT technology and the best implementation practice of these techniques

vMoving from batch manufacturing to continuous manufacturing, how to effective implement this, how this will aid quality by design and overcoming the problem of defining a batch

WWW.PATANDQBD.COM

www.PAtAndQbd.com

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