Achieving effective, repeatable, risk-based pharma change control

Achieving effective, repeatable, risk-based pharma change control

Achieving effective, repeatable, risk-based pharma change control

Most life sciences products continue to evolve long after approved formulations have entered the market, and all of these changes must be carefully tracked, managed and reported to maintain registrations, manufacturing transparency and patient safety.

In addition to updates to the product itself, or to the location or equipment used in manufacture, changes could result from revised regulatory or legal requirements, a response to quality issues, or corrective actions after an audit. Other changes may come from the business environment, or internal strategy.

Putting in appropriate change controls, guided via repeatable steps, also helps with identifying and containing any risk, which is important to maintain QA rigour and keep pace with legislation. It’s a fundamental expectation by regulators, in fact.

‘Change control’ refers to a systematic approach to managing all changes made to a product or a system – ensuring that no unnecessary changes are made; that all changes are documented; that manufacturing and distribution will not be unnecessarily disrupted; and that all resources are used efficiently. Usually, this will be handled within a pharmaceutical quality system.

All pharmaceutical regulatory guidelines, including Good Manufacturing/Distribution Practice (GMP/GDP), cover change management. They specify regulatory notification and approval where required, and the need for post-change evaluation – to confirm that quality objectives were achieved at that, and that there was no unintended impact on product quality.

Pain avoidance

Beyond satisfying regulators and keeping patients safe, effective change control leads to improved cost and risk avoidance associated with deviations, complaints, recalls. Being proactive in understanding and planning for the potential impact of future changes, meanwhile, can lead to smoother implementations. Future changes can be factored in with less disruption to the manufacturing schedule, for instance.

Conversely, a single inadequate change could lead to significant negative effects, including the release of a sub-standard product, potentially leading to product recall. A pattern of inadequate changes, meanwhile, could result in costly, time-consuming system remediation, not to mention the hidden costs of a loss of physician and patient confidence in the brand.

The more proactive, pre-emptive and methodical companies can be, the lower these risks.

What does good look like?

A systematic approach to change control will leave nothing to chance, boosted by timely notifications to teams to complete tasks promptly. A good system will allow this kind of workflow to be automated, in compliance with given parameters – so that the QMS system or equivalent software assigns tasks and issues notifications, without someone having to remember to do this.

So how can you evaluate the effectiveness of a risk-based change management system, if you’re implementing such a solution for the first time?

Here are some useful features and attributes to look out for:

  • Controls to ensure that all proposed changes are formally evaluated, and a decision to accept or reject the proposal is documented, along with the related rationale.
    • The objectives, scope and the expected outcomes/benefits of any changes should be detailed too, so look for a system that provides for all of this.
  • The ability to include all relevant subject matter experts and appropriate internal or external stakeholders as applicable – those involved in the change proposal development and in the approval of the change.
    • Any impact on pending or approved filings and regulatory commitments will need to be considered and addressed as an integral part of the change control process.
  • Scope for risk-based classification, and support for a holistic impact assessment spanning product quality, documentation, cleaning, maintenance, regulatory compliance and so on.
    • The change management system should ensure that appropriate science- and knowledge-based risk assessments, by the subject matter experts, are performed and documented.
    • The level of formality and effort and documentation must be commensurate with the identified level of risk, both current and projected for the future.

Contributing to better output

Ultimately, change control is a quality system. It should never be reactive; rather it should be planned, intentional and purposeful, demonstrated via comprehensive documentation of decisions made and actions taken – and their justification. In fact, a good change management system should drive risk reduction to ensure better quality and manufacturing performance, boosted by continuous improvement and innovation.

But this also assumes that teams understand their own obligations, their respective roles and responsibility in evaluating changes properly and ensuring that the entire process is seen through properly, and that everyone buys into it.

Amplexor’s change control software provides the tools to monitor all types of changes that could influence the process, reliability or product quality; evaluate them in the context of regulatory requirements; and take them forward as appropriate, backed by appropriate documentation. Change information and approval within the system is transparent, and task tracking is intuitive and convenient, both for the manager and those performing the tasks.

We also provide a workspace for SOP management, for all kinds of actually quality documentation, and associated processes – such as deviation management, complaints, out of specification results, audits, CAPA management and supplier qualification.

In short, we’ve thought of everything so that you don’t have to.

Vanja Primorac

Vanja Primorac

Life Science Consultant

About the author

Vanja Primorac is a life science consultant and QA specialist at Amplexor in Zagreb, Croatia, contributing to the development of and enhancements to the company’s software. A qualified pharmacist, she previously worked at GlaxoSmithKline as a QA Responsible Person and Senior Quality Executive.

 

Be The Expert Day 3

Be The Expert Day 3

ONLINE EVENT ON DEMAND

Be The Expert 2022

Day 3 Presentations

Amplexor Life Science’s conference Be The Expert brings together leading subject matter experts and industry professionals from around the world into one forum to discuss and exchange strategies that combat challenges confronting the Life Sciences industries.

 

Watch the presentations from Be The Expert 2022 Day 3 virtual event.

About the video

Video recording from Day 3 Be The Expert 2022 virtual conference featuring:

1. Danijel Saifert, Amplexor Life Sciences: The impact of SaaS on the Pharmaceutical industry – to Cloud or not to Cloud?

2. Thierry Dietrich, Pharm@dviser: Ensuring data integrity and computerized system validation in the cloud

3. Vanja Primorac, Amplexor Life Sciences: Grab your business by the KPIs!

About the speakers
Danijel Saifert

Danijel Saifert

Senior Manager Strategic Accounts, Amplexor Life Sciences

Danijel Saifert is Senior Manager for Strategic Accounts in Amplexor Lifescience. He is the holder of numerous technical certificates and scientific papers

on the topic of distribution computer systems and cloud. He has more than 10 years of experience in Managed services and Cloud infrastructure and SaaS, PaaS and IaaS.

He has built his career in companies such as ATOS and Samsung.

Dr. Thierry Dietrich

Dr. Thierry Dietrich

Founder at pharm@dviser

Dr. Thierry Dietrich serves in leading and consulting positions within the pharmaceutical and medical devices industries for more than 20 years. He founded pharm@dviser in 2016, and acts as management consultant.

His areas of focus are data integrity auditing, auditing of IT suppliers and IT organizations, leading of large IT projects in GxP regulated areas, validation of computerized systems, as well as the building and optimization of quality management systems with focus on IT and data quality.

Thierry Dietrich was/is leader resp. member of several GAMP® SIGs and ISPE. He also is the author of numerous technical publications, co-author on data integrity related books, and speaker on technical conferences. He received his PhD in natural sciences and master degree in chemistry from Johann Wolfgang Goethe University Frankfurt.

Vanja Primorac

Vanja Primorac

Life Sciences Consultant, Amplexor Life Sciences

As a Life Sciences Consultant, Vanja is responsible for the contribution to the development and enhancement of the Amplexor Life Sciences Suite, as well as the provision of business process and data management expertise to Amplexor clients in the area of Quality Assurance.

Before joining Amplexor, Vanja worked in GlaxoSmithKline, where she was holding the position of Senior Quality Executive and Responsible Person.

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Be The Expert Day 2

Be The Expert Day 2

ONLINE EVENT ON DEMAND

Be The Expert 2022

Day 2 Presentations

Amplexor Life Science’s conference Be The Expert brings together leading subject matter experts and industry professionals from around the world into one forum to discuss and exchange strategies that combat challenges confronting the Life Sciences industries.

 

Watch the presentations from Be The Expert 2022 Day 2 virtual event.

About the video

Video recording from Day 2 Be The Expert 2022 virtual conference featuring:

1. Tris Nockels, IRSS Forum/Navitas: The future of labeling – a digital reality?

2. Remco Munnik/Dennis Verhaegh, IPERION: Streamline IDMP data in your RIMs to accelerate your eSubmissions and labeling

3. Renato Rjavec, Amplexor Life Sciences: Electronic submissions in the data-driven regulatory operations

About the speakers
Tris Nockles

Tris Nockles

Regulatory Industry Thought Lead at Navitas

Tris Nockles has been leading the Navitas Regulatory Industry Networks for the last two years, with 18+ years of industry exp in Life Sciences, Devices & Consumer Products. She specializes in strategy, process improvement and development initiatives focusing on Regulatory, E2E labeling & RIM. Tris is located in the UK, and is fortunate to live near the coast where she loves to walk on the beach with her partner and her three dogs.

Remco Munnik

Remco Munnik

Director at Iperion

Remco Munnik is a Director at Iperion, a Deloitte company. He has more than 20 years’ experience in Life Science and Regulatory Affairs, including more than a decade providing consultancy around Regulatory Information Management (RIM) and electronic submissions. He is a respected subject matter expert in RIM, eCTD, xEVMPD and ISO IDMP.
Remco is also an active member of EMA ISO IDMP Task Force Organizations and Products; Chair of Medicines for Europe Telematics group; and Vice-President of the IRISS Forum, a global, open, multidisciplinary, non-profit networking organisation for life science professionals by life science professionals. One of Iperion’s widely-acknowledged strengths is its deep networking with stakeholders across life sciences – including regulators, software vendors and customer groups.

Renato Rjavec

Renato Rjavec

Director of Products, Amplexor Life Sciences

As Director of Products, Renato is responsible for Amplexor’s Life Sciences Solution Product Management. Over the last fifteen years with the company, he held several positions within the delivery and product management organization where he acquired broad experience in analyzing, designing and implementing end-to-end regulatory solutions for the global Life Sciences industry.

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Be The Expert Day 1

Be The Expert Day 1

ONLINE EVENT ON DEMAND

Be The Expert 2022

Day 1 Presentations

 

Amplexor Life Science’s conference Be The Expert brings together leading subject matter experts and industry professionals from around the world into one forum to discuss and exchange strategies that combat challenges confronting the Life Sciences industries.

Watch the presentations from Be The Expert 2022 Day 1 virtual event.

About the video

Video recording from Day 1 Be The Expert 2022 virtual conference featuring:

1. Kelly Hnat, K2 Consulting: Preparing for IDMP in times of uncertainty: What now?
2. Steve Gens, Gens and Associates: Industry RIM status: How are companies evolving and investing in the near and longer term?
3. Agnes Cwienczek, Amplexor Life Sciences: The Impact of IDMP on Regulatory Information Management

About the speakers
Kelly Hnat

Kelly Hnat

Principal at K2 Consulting

Kelly Hnat is a leader in RIM and IDMP with over 25 years’ experience in the biopharmaceutical industry leading IT, RIM, and Regulatory Operations organizations.  Kelly is a globally recognized expert in IDMP and is a key subject matter expert supporting the EU implementation of IDMP as a member of the EMA SPOR Task Force, the SPOR PMS sub team, and the SPOR EU Implementation Guide Focus Groups.  Additionally, she is a member of ISO TC215/WG6, is a member of the Core Research Team for the Gens & Associates World Class RIM survey, and serves as President/CEO of IRISS Forum, a global nonprofit organization that brings together industry, vendors, and health authorities to address topics related to submission standards.  Kelly leads K2 Consulting, a boutique consultancy that provides business process, organizational strategy, and technology strategy services for Regulatory Affairs organizations.

Steve Gens

Steve Gens

Managing Partner of Gens and Associates

Steve Gens (MSOD) is the Managing Partner of Gens & Associates Inc., A Life Science benchmarking and advisory firm specializing in performance improvement, strategy, regulatory information management, and organizational transition. His early career was spent at Johnson and Johnson in a variety of management positions and then transitioned to consulting where he led global Life Science consulting practices for First Consulting Group and Booz Allen Hamilton.

His organization is well known for their insightful industry benchmarks, World Class RIM industry performance standard, and thought leadership. Steve has a Bachelor of Science in Business Computer Science and a Master in Organizational Development. He is a frequent speaker, has many publications, and was named to the 2017 PharmaVoice 100 and as an innovator in the 2021 Innovations in Pharmaceutical Development™ for his contributions to industry.

Agnes Cwienczek

Agnes Cwienczek

Head of Product Management and Consulting, Amplexor Life Sciences

Agnes has been in the position of ALSS Head of Product Management and Consulting since May 2017. Her main responsibilities are the contribution to the development and enhancement of the Amplexor Life Sciences Suite, supervision of the Life Sciences Consultants as well as the provision of business process and data management expertise to Amplexor clients in Regulatory Information Management, Document Management, and Submission Management.

Before joining Amplexor, Agnes worked at Merck KGaA in Global Regulatory and Quality Assurance, where she was acting System and Process Owner for all regulatory owned systems, providing global leadership for the management of submission documents, regulatory data and archiving within the Merck Biopharma organization.

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Be The Expert Day 1

Cloud control: maintaining compliance as regulated apps move off premise

Cloud control: maintaining compliance as regulated apps move off premise

As pharmaceutical companies become more confident and ambitious in their use of the cloud to host, run and source applications, more recently extending the model to regulated applications, important considerations arise – particularly around associated systems validation and data governance.

At Amplexor BE THE EXPERT 2022, I will discuss the different levels of cloud use and the best approaches to ensuring compliance in each case, as regulators pay closer attention to cloud-based data management.

The general trend toward cloud-based IT and cloud-hosted applications use shows no signs of abating, and the life sciences industry – albeit behind the curve – has been making its own steady progress in moving its systems off premise.

Now that they have tested the water with unregulated applications, many of these companies are exploring the potential to move more sensitive systems off site, in the expectation that this will enable greater flexibility, collaborative potential, productivity and efficiency, and improved dynamism in an environment that is evolving continuously.

Balancing risks & rewards

As team leaders and/or IT departments become more persuasive about the benefits of running more activities via the cloud, it’s important that companies are not exposed to increased risk, however. New measures may need to include additional levels of protection as data travels across the Internet and more ‘open’ systems (for example, harnessing end-to-end data encryption).

While sharing much of the enthusiasm about the potential for cloud-based process transformation, regulators too are well aware of the associated scope for data breaches, data losses/corruption, and other new vulnerabilities – and the changing emphasis of their inspections reflects this.

Neither the regulators, nor company Quality managers, want to risk data quality, process continuity, or patient safety in the rush to make more comprehensive use of the cloud. There is a balance to be struck, they realize, between greater agility, system security, and data integrity. After all, even if ownership of the IT systems is transferring to a cloud-based system provider, legal accountability for the data and what happens to it remains squarely with the regulated company.

Not all cloud deployments are equal

It’s this delicate balancing act that I’ll be speaking about in my session at BE THE EXPERT 2022, with consideration for the different levels of cloud use.

That’s because internal system and data controls will vary depending on whether the company is merely taking advantage of a cloud-based infrastructure (via Infrastructure as a Service, or IaaS); whether they are harnessing a cloud-based platform (Platform as a Service, or PaaS) as the means to develop or integrate applications; or whether they are subscribing to an application under the ownership and control of a third party (Software as a Service, or SaaS).

Given this granularity, it follows that validation and data integrity/governance strategies will need to be developed or adapted according to the specific cloud approach, to ensure that companies retain – and can demonstrate – appropriate levels of control.

More often than not, pharma companies will lack the nuanced knowledge and resources to cope with all of this, but there is help available and it’s important that they draw on this as needed to fulfil their obligations.

 I look forward to discussing these themes with you. Register for the event here!

Dr. Thierry Dietrich

Dr. Thierry Dietrich

Founder & Owner, pharm@dviser

About the author

Dr. Thierry Dietrich serves in leading and consulting positions within the pharmaceutical and medical devices industries for more than 20 years. He founded pharm@dviser in 2016, and acts as management consultant.

His areas of focus are data integrity auditing, auditing of IT suppliers and IT organizations, leading of large IT projects in GxP regulated areas, validation of computerized systems, as well as the building and optimization of quality management systems with focus on IT and data quality.

Thierry Dietrich was/is leader resp. member of several GAMP® SIGs and ISPE. He also is the author of numerous technical publications, co-author on data integrity related books, and speaker on technical conferences. He received his PhD in natural sciences and master degree in chemistry from Johann Wolfgang Goethe University Frankfurt.

Be The Expert Day 3

Dynamic digital labels: from local pilot to regional reality

Dynamic digital labels: from local pilot to regional reality

The potential of truly digital, data-driven product labeling in life sciences is huge, allowing companies to tailor and update their information more readily, unencumbered by space restrictions or print/production line deadlines. But what will it take for today’s discrete, local pilot projects to evolve into something more permanent and transformational for patients and healthcare professionals?

At Amplexor BE THE EXPERT 2022, I will assess the latest developments, the emerging challenges that need to be resolved, and what’s needed now to maintain and build momentum.

Although digital labeling is widely available today across the globe through regulatory agency, trade association and company websites, this is largely in the form of static, unstructured content presented as published pdfs. While this option offers patients and healthcare professionals the convenience of easy lookup (in the event that packets and patient information leaflets have been mislaid, for instance), as well as the ability to make text larger, the broader benefits are limited. That’s because the content isn’t dynamic – based on the very latest data, reflecting updates as they happen. Or not yet, anyway.

Industry is faced with a perplexing array of implemented and emerging regulations, alongside an increasing variety of pilots and intitiatives, and whilst all will contribute to the evidence base for a more dynamic, data-driven labeling reality, balancing the complexity within an already fragmented labeling regulatory environment remains a challenge.  So, the question is, how do we deliver the best labeling experience for each, and every patient based on their needs?

In my presentation at BE THE EXPERT 2022, I’ll take us through some of the latest digital labeling pilots currently underway around the world – from the Benelux region of Europe, which is testing digital labeling at a hospital prescribing level; to Singapore, which has moved past the pilot phase to embrace e-labelling nationally (but without the Regulator acting as the online hub for approved content). I’ll also ask what can be learned from the example of Australia, as a country which defaulted to online labeling for most products a great many years ago.

Each model currently being trialed or rolled out introduces its own benefits, and challenges. Practical considerations include:

  • What is patients’ readiness for this fundamental change in how they access information about their medicines and/or medical devices, and what are the technical hurdles?
  • How will patients be notified about updates to digital information (e.g. revised safety guidance)?
  • Which code should be the standard for unlocking digital information? (QR codes are well supported by popular makes of smartphone, but harnessing the GS1 serialization code would minimize physical label ‘clutter’.)
  • What will need to happen at a supply chain level/from a validation perspective, given that the paper label is part of the structural integrity of a product?

Certainly, there is much to be excited about as advances in technology converge with regulator openness to drive the current wave of pilot activity – from which there can be no going back.

The overarching challenge now is how to convert current momentum into something with broader impact and greater global coordination, so that practices are transformed irreversibly, and sustainably – with critical mass.

 I look forward to discussing these themes with you at BE THE EXPERT.

Tris Nockles

Tris Nockles

Regulatory Industry Thought Lead at Navitas

About the author

Tris Nockles has been leading the Navitas Regulatory Industry Networks for the last two years, with 18+ years of industry exp in Life Sciences, Devices & Consumer Products.  She specializes in strategy, process improvement and development initiatives focusing on Regulatory, E2E labeling & RIM. Tris is located in the UK, and is fortunate to live near the coast where she loves to walk on the beach with her partner and her three dogs.