Lean Qualification and Validation team aim for waste reduction

Lean Qualification and Validation team aim for waste reduction

The Lean Qualification and Validation (LQV) Workstream group was graciously hosted at the GlaxoSmithKline headquarters in Brentford, UK this past March to kick-off the team’s first face-2-face after several months of long-distance conference calling. The team has been commissioned to identify ways to reduce waste in the qualification and validation of new equipment and facilities.

To help get the team on its feet and baseline the industry, a survey of 23 questions was answered by 11 of the 16 sponsoring companies participating in the workstream. The survey sought to help frame up the team’s perspectives around:

  • Where is the industry regarding its journey to becoming more risked-based?
  • What approach are company’s currently taking regarding risk-based QV?
  • Is there a significant driver necessitating a move to a more risked-based approach?

 

The LQV group reviewed the responses and began to come to an understanding of where the industry sits today based on those who responded. Overall, more than 90 per cent of companies surveyed are currently using or are well on their way to adopting risk-based approaches.

But what does “using” or “adopting” mean? This is where the differences in approach begins to emerge. The survey found that by “using” or “adopting” a risked-based approach, companies are actively incorporating risked-based qualification and validation approaches along a broad spectrum with influence by guidelines and standards such as ICH, ISPE, and ASTM e2500 to various degrees.

So, is there a problem with how companies are doing it now? Should the industry make a move towards a riskier approach? The survey provided some light on these questions. Based on the survey results it was abundantly clear that reducing compliance risk and QV cost are not going to be sufficient motivators for the industry as companies are generally satisfied with their current approach. Approximately 80 per cent of the companies indicated that QV activities do not comprise more than 20 per cent of a project’s budget and very few regulatory findings or company risks were identified involving their current practices.

With this said, the survey helped spark and direct the team’s brainstorming to truly identify what companies are feeling when it comes to efficiency in qualification and validation of equipment and facilities. However satisfied companies may be, all companies which responded indicated that change to their QV strategies are being considered or implemented. But why change? Based on our survey’s question around current QV pain points, companies responded with examples that demonstrated over-production, over-processing, waiting, rework, and a myriad of other signature wastes in lean manufacturing. As a manufacturing industry, we all recognize there is room to improve.

Is there a less wasteful method for QV that can be accomplished without jeopardizing the high marks of the current compliance strategy? How will this improved method get implemented across the industry? When will this improved method get implemented?Can we implement something for existing facilities? All questions the team plans to tackle. Enter the SIPOC…

As the team is only beginning to face the task at hand we are excited to see what a group of the brightest minds from the world’s leading companies in medicine manufacturing paired can cook up.

Written by Drew Graves, Catalent

Contact address

BioPhorum
The Gridiron Building
One Pancras Square
London
N1C 4AG

Newsletter subscribe

You can unsubscribe at any time by clicking the link in the footer of our emails. For information about our privacy practices, please visit our website.



© 2019 Biophorum Operations Group · All Rights Reserved

Registered Address: 5 Westbrook Court · 2 Sharrow Vale Road · Sheffield · S11 8YZ

Company Number 06794795 · VAT Number GB298617544

Driving progress in Cell & Gene Therapy

Now with 19 member companies and 183 subject matter experts, the BioPhorum Cell & Gene Therapy (C>) Phorum has made great strides since its formation[...]

Read More
Join BioPhorum at BioProcess International events

We have partnered with BioProcess International for more than five years. In that time, their conferences have provided platforms to socialize the collaboration’s key new[...]

Read More
Cell and Gene Therapy Phorum accelerates progress

The BioPhorum Cell & Gene Therapy Phorum has made significant progress since its creation in 2018 – from building networks and sharing knowledge to endorsing[...]

Read More
The BioPhorum and USP collaborative journey to new standards

BioPhorum and United States Pharmacopeia (USP) share a common direction – to accelerate biopharma innovation, quality and progress through collaboration.

Read More
Perfecting balanced scorecards for CDMOs

Established in March 2017, the Development Group’s Development Outsourcing effort aims to share and build guidance that will help companies make the best decisions and[...]

Read More
Formulation team drive for more value

Since its start in 2013, the Formulation Point Share has been busy. Its latest article, An inter-company perspective on biopharmaceutical drug product robustness studies, was[...]

Read More
Join BioPhorum at BioProcess International events

We have partnered with BioProcess International for more than five years. In that time, their conferences have provided platforms to socialize the collaboration’s key new[...]

Read More
2018 highlights

BioPhorum’s mission has always been to make the journey for tackling industry challenges better, faster and cheaper for members. By helping you to work on[...]

Read More
Why leaders should go to where work is performed to learn about success, failure and risk
Read More
Hi-tech ambitions for Fill Finish

The Fill Finish Phorum has recently embarked on a series of exciting and ambitious initiatives, exploring new technologies and processes to enhance the efficiency and[...]

Read More
Companies poised to follow ARMM recommendations

The Advanced and Rapid Microbial Methods (ARMM) team set out a clear case for modernizing Environmental Monitoring (EM) in grade A settings: in summary bio-fluorescent[...]

Read More
How to achieve the ‘Goldilocks’ amount of environmental monitoring

Regulators require a risk-based approach to environmental monitoring (EM)… but they give no clear definition of what “risk-based” actually means. The aim of the Environmental[...]

Read More
The ‘how to’ guide to implementing Agile in GxP

The publication of the Guidance on the use of Agile in a GxP Environment document in 2017 was well received.It described how the use of[...]

Read More
How smart is your maintenance?

Faster. Cheaper. Smarter. All companies are under pressure to achieve more with less, not least with their maintenance programs. But while ‘faster’ and ‘cheaper’ maintenance[...]

Read More
2018 highlights

BioPhorum’s mission has always been to make the journey for tackling industry challenges better, faster and cheaper for members. By helping you to work on[...]

Read More
Join BioPhorum at BioProcess International events

We have partnered with BioProcess International for more than five years. In that time, their conferences have provided platforms to socialize the collaboration’s key new[...]

Read More
Supply chain, forecasting and demand planning solutions gain momentum

The relationship between suppliers and manufacturers is one of the most crucial in biopharmaceutical manufacturing. This is especially the case when forecasting and supply planning.[...]

Read More
2018 highlights

BioPhorum’s mission has always been to make the journey for tackling industry challenges better, faster and cheaper for members. By helping you to work on[...]

Read More
Changing mindsets with a modular approach

Historically, manufacturers have used a ‘waterfall’ approach when designing and building their production facilities, sequentially resolving and specifying all aspects up front and in detail[...]

Read More
Join BioPhorum at BioProcess International events

We have partnered with BioProcess International for more than five years. In that time, their conferences have provided platforms to socialize the collaboration’s key new[...]

Read More
How do you bring technology roadmapping to life?

You use it to make change happen and that is exactly what the Phorum’s leaders did after the first edition of the Biomanufacturing Technology Roadmaps[...]

Read More
Slicing years off change implementation

As the first regulatory authority in Latin America to gain full membership of the International Council for Harmonization (ICH), the Brazilian Health Regulatory Agency (Anvisa)[...]

Read More
BioPhorum Regulatory Interaction: helping to open doors

To implement any change in the biopharmaceutical manufacturing industry it is important to engage with and collaborate with the regulators. Set up two years ago,[...]

Read More

IaaS Cloud webinar recording play back
Read More
New BPIT guidance to align cloud services to regulatory requirements
Read More
Data Integrity and Agile Webinars to support industry response to regulators
Read More
How to validate informatics in CPV programs

The BioPhorum Continued Process Verification (CPV) and Informatics team has published a paper to support a risk-based approach for the validation of informatics systems for[...]

Read More
Continued Process Verification delivering real saving in time and money

More than 50 per cent of biopharma products on the market now have Continued Process Verification (CPV) plans in place.  Thanks to the CPV white[...]

Read More
A roadmap for the implementation of continued process verification

This article provides a roadmap draws on the content of the CPV case study to provide a step-by-step guide in a more accessible form.

Read More
How smart is your maintenance?

Faster. Cheaper. Smarter. All companies are under pressure to achieve more with less, not least with their maintenance programs. But while ‘faster’ and ‘cheaper’ maintenance[...]

Read More
Digital plant maturity model webinar replay
Read More
Digital Plant Maturity Model workstream to host webinar
Read More
New guidance available on Forecasting and Demand Planning to streamline supply chain performance
Read More
Host cell proteins poster

This poster presented at the BEBPA Conference, San Francisco builds and consolidates the information currently available in the industry for assessing process risk from Host[...]

Read More
Host cell protein risk assessment, an industry approach

Host cell protein (HCP) constitutes a significant class of process-related impurities in biological drugs.

Read More
BEBPA risk assessment workshop
Read More
New toolkit to accelerate single-use design and specification

The single-use user requirements toolkit is now live and available for free download on the BioPhorum website  The toolkit streamlines the design and specification process[...]

Read More