TwitterLinkedin

Contact Us

  • Biopharma Excellence
  • News & Events
    • Industry News Articles
    • Press Releases
    • Webinars
    • Events
    • Blog
    • Podcasts
  • Resource Library
    • Thought Leadership
    • Fact Flyers
    • Case Studies
    • White Papers
    • Webinars
    • Infographics
    • Video & Animation
  • Careers
    • Life at PharmaLex
    • Current Opportunities
  • Training
Top Bar
Search
PharmaLex Logo
MENUMENU
  • PharmaLex Logo
  • PharmaLex Logo
  • About UsAbout Us
    • About Us
    • Management Team
    • Corporate Social Responsibility
    • What Our Clients Say About Us
  • Our Services
    • Discovery / Non-clinical
          • Go to Discovery / Non-clinical section >>

          • Strategy and Consulting

            • Integrated Product Development
            • Market Access
            • Scientific Advice
            • Statistics and Data Sciences
            • Toxicology Services
    • Clinical Development
          • Go to Clinical Development section >>

          • Strategy and Consulting

            • Clinical Program Development
            • Scientific Advice
            • Statistics and Data Sciences
          • Regulatory Affairs

            • Clinical Trial Applications
            • Global Procedure Management
            • Health Authority / Agency Interaction
            • Regulatory Operations
          • Pharmacovigilance

            • Clinical Trial Safety Support
            • Pharmacovigilance Consulting
          • Quality

            • GxP Services
            • Interim / Contract QA
            • Quality Management Systems
            • Tech Transfer / Scale-up
    • Authorization / Approval
          • Go to Authorization / Approval section >>

          • Strategy and Consulting

            • Market Access
          • Regulatory Affairs

            • CMC Services
            • Global Procedure Management
            • Health Authority / Agency Interaction
            • Marketing and Labeling Activities
            • Regulatory Operations
            • Scientific, Regulatory and Technical Writing
            • Statistics and Data Sciences
          • Pharmacovigilance

            • EU QPPV / National QPPV
            • Pharmacovigilance Consulting
          • Quality

            • Commercialization Readiness
            • Commissioning, Qualification, and Validation (CQV)
            • GxP Services
            • Interim / Contract QA
            • PAI Readiness
    • Post-approval / Maintenance
          • Go to Post-approval / Maintenance section >>

          • Strategy and Consulting

            • Market Access
          • Regulatory Affairs

            • CMC Services
            • Global End-to-End Outsourcing
            • Global Procedure Management
            • Health Authority / Agency Interaction
            • Marketing and Labeling Activities
            • Mergers and Acquisitions (M&A) Transfers
            • Regulatory Operations
            • Toxicology Services
          • Pharmacovigilance

            • EU QPPV / National QPPV
            • ICSR (Individual Safety Case Report) Management
            • Literature Monitoring & Screening
            • Pharmacovigilance Quality & Compliance
            • Signal Management
          • Quality

            • Commissioning, Qualification, and Validation (CQV)
            • GxP Services
            • Interim / Contract QA
            • Quality Management Systems
          • Medical Affairs

            • Healthcare Compliance and Medical Approval
    • Program Management
          • Go to Program Management section >>

          • Program Management

            • Global End-to-End Outsourcing
            • Global Procedure Management
            • Integrated Product Development
            • Mergers and Acquisitions (M&A) Transfers
    • Featured Expertise
          • Industry Expertise

            • Biopharmaceuticals
            • MedTech Services
          • Service Expertise

            • ATMP / Cell and Gene Therapy
            • COVID-19 Support
            • GxP Services
            • Market Access
            • Pharmacovigilance Consulting
            • Post-Brexit Regulatory Support
            • Statistics and Data Sciences
            • SMARTPHLEX - technology-enabled services
  • Global ReachGlobal Reach
  • Contact usContact us
  • News & Events
    • Industry News Articles
    • Press Releases
    • Webinars
    • Events
    • Blog
    • Podcasts
  • Resource Library
    • Thought Leadership
    • Fact Flyers
    • Case Studies
    • White Papers
    • Webinars
    • Infographics
    • Video & Animation
  • Careers
    • Life at PharmaLex
    • Career Opportunities
  • Training
Home > News & Events > Blog > Is quality documentation an asset or a burden in regulatory affairs?

Is quality documentation an asset or a burden in regulatory affairs?

Martin Knieps-Hastenrath

Quality documentation (QD) defined under GxP principles is a requirement for many departments/functions within the pharmaceutical industry. But in the crucial area of Regulatory Affairs (RA), there is usually very little incentive to commit resources to detailed quality documentation, with most seeing it as a burden rather than a strategic asset.

One area of particular note is training, where approaches based solely on QDs are outdated, don’t reach the right target group in- and outside of RA or are not understood. The challenge is there has been no real commitment to investing the time and effort in maintaining updates to training material. There are several reasons for this, including that modern training approaches must cope with increasing employees’ expectations of on-demand knowledge delivery and interactive training; that the target group for the QD training is constantly changing in line with changes in the organization; or because of the time involved in updating the QD.

Currently the overall number of QDs in RA is historically high in a lot of global pharmaceutical companies. RA would do well to consider strategies, such as to develop less rigid but no less valuable documentation on business processes and for training outside the Quality Management System instead of further investing in QDs where not needed and to design smart QDs only when needed. This will enable RA to save costs and time in the mid-term.

Consider the main driver for changes in RA

The difference between RA and other functions is that the legislation refers to what has to be done and even the timelines in which data and information must be delivered to Health Authorities. The how has usually been defined in rather technical or content guidance, with the technical requirements rapidly increasing in the digital area (see blog on Navigating New Digital Regulatory Requirements).  But how exactly to most effectively achieve a submission-ready dataset or dossier has still been a matter of flexible internal processes and operating models matching these requirements. This flexibility in the “how” aspect of RA explains why there has been little impetus when it comes to developing QD.

Global pharmaceutical companies are constantly trying different operating models to determine which is most efficient for the business – e.g. from handling everything at a global level to moving to local or regional reporting to sending everything to low cost offshore hubs.

From the QD management perspective a core question is whether it is principles or processes that are impacted by a change or rather the operating model. For example, while there may be major regulatory developments, the high-level principles and processes of how to prepare a dossier or a dataset for a regulatory submission have not changed for many years.

To save resources, documentation in RA requires a smart design

Indeed, quality documentation might even present hurdles for RA due to the fact that it must be maintained within the quality system, which means every process deviation, every change in operation model, every adaptation to KPIs in the QDs has to be reported, justified, and documented.

Many companies define/specify internal timelines and key performance indicators in their QD. The question is, why? Recording and tracking all these data and non-core process-related changes in the QD is pointless and time-consuming because it means the QD has to be continuously – yet unnecessarily — updated. Ideally, companies should establish a target timeline rather than a fixed timeline to avoid falling into non-compliance if a timeline isn’t met and should avoiding defining internal KPIs in their QDs.

Instead, companies would do well to develop documentation for RA outside the Quality Management System to identify the activities that need to be carried out whenever there is a change to the operating model, the KPIs or the target timelines, with the relevant change information communicated through these supplemental documents.

The objective should be to steer the workforce to support a defined operating model and to work to meet timelines and KPIs while ensuring the business isn’t locked into a rigid approach that will require constant and ongoing documentation updates.

Focus on Documenting and Optimizing processes

The best practice processes described might best be understood through an example.

A biopharma company sought to find ways to better manage its processes. The organization had implemented a Lean Six Sigma business process management approach that it wanted to introduce across the entire business area. The challenge was that the process didn’t fit seamlessly with the way RA operates. Unlike other functions, RA doesn’t run linear work processes. Regulatory activities are not generally handled in defined consecutive steps, so the department requires flexibility to carry out activities as required – sometimes sequentially, sometimes in parallel and not always in the same order.

From a resource perspective, regulatory activities require different roles and responsibilities, a submissions expert, someone with local knowledge, a strategist, a person to plan the submission and so on. The challenge was how to put this on paper without creating barriers and limitations for the department. The solution was to thoroughly define single processes but keep the connection points of the processes flexible. This allows for the flexibility between the workstreams while ensuring the processes required for successful preparation of a submission remain clearly defined.

This is a gamechanger for RA since it ensures the objectives of business process management are met while allowing for flexibility in terms of how the regulatory team works and carries out activities.

Managing this more flexible and efficient approach within the context of Six Sigma ensured the whole approach began with a better understanding of the function and how it operates by asking key questions: Why does this process need to be run? What are the goals and outputs when running this process? How does the process need to proceed? And how can or should efficacy and efficiency be measured?

People first

As companies look at how best to move forward with their process documentation, top of mind with the operating model should be how people within the function operate and develop processes to meet those needs. What expertise do the employees have and how is it used? How can that knowledge be maintained and developed? And how can the organization ensure its people are appropriately trained? It starts with having the best training concepts in place to enable employees to carry out the processes, rather than requiring people to adapt to the processes.

 

Given the limitations quality documentation can impose if a company incorporates all activities and operating models, it’s advisable to take a more holistic change approach to optimization processes and their documentation, QD management and trainings in RA. This should include:

  • Map the RA process landscape
  • Determine which processes have to be covered in QDs, limiting the number of QDs
  • Before adapting the documentation, evaluate how people are trained on processes and QDs and how that training is perceived
  • Determine how compliant employees are to what is written in the documentation and whether they understand the process
  • Determine how to improve the training approach and the processes
  • Adapt the documentation
  • Implement

About the author:

Martin Knieps-Hastenrath, Director, Principal Consultant, Regulatory Affairs at PharmaLex, has 15 years of experience in RA with focus on interfaces in post-marketing surveillance. Martin is a biologist/biochemist by training with deep understanding of the expert requirements regarding proper regulatory document, system and information management.

Related posts
Navigating the impact of the IVDR on marketed products
Navigating the impact of the IVDR on marketed products
24th March 2022
Minimizing risk during the transport of medicinal products
Minimizing risk during the transport of medicinal products
21st March 2022
Next Steps for EUDAMED implementation within MDR
Next Steps for EUDAMED implementation within MDR
7th March 2022
How Advanced Therapeutic Mergers & Acquisitions Impact Negotiations and Integration
How Advanced Therapeutic Mergers & Acquisitions Impact Negotiations and Integration
26th February 2022
Planning for Post-Emergency Use Authorization (EUA) for Medical Devices and IVDs
Planning for Post-Emergency Use Authorization (EUA) for Medical Devices and IVDs
24th February 2022
Navigating New Digital Regulatory Requirements
Navigating New Digital Regulatory Requirements
7th February 2022
Recent Blogs
  • Is quality documentation an asset or a burden in regulatory affairs?
    6th April 2022
  • Navigating the impact of the IVDR on marketed products
    24th March 2022
  • Minimizing risk during the transport of medicinal products
    21st March 2022
  • Next Steps for EUDAMED implementation within MDR
    7th March 2022
  • How Advanced Therapeutic Mergers & Acquisitions Impact Negotiations and Integration
    26th February 2022
  • Planning for Post-Emergency Use Authorization (EUA) for Medical Devices and IVDs
    24th February 2022
Recent News
  • Addressing Limitations of Sterility Testing
    9th May 2022
  • Are virtual audits sustainable post-pandemic?
    6th May 2022
  • Orphan Drug Designation: Securing the Significant Benefits
    28th March 2022
  • PharmaLex expands pricing & reimbursement and health economics platform with EBMA Consulting merger
    9th March 2022
  • PharmaLex extends reach to Japan, East Asia and Southeast Asia with Ascent Development Services merger
    8th February 2022
  • Virtual Audits: To be, or not to be, that is the question
    26th January 2022
Upcoming Events

September 28 - May 29th, 2022

NLS DAYS 2022

Visit us at booth X51

Biopharma Excellence Website Image

PharmaLex Brings You Biopharma Excellence

Biopharma Excellence is a fusion of three scientific powerhouses, PharmaLex, ERA Consulting and Biopharma Excellence – all under the PharmaLex brand. This global team of scientific, regulatory and commercial professionals provide strategic product development and proactive regulatory services to developers of biopharmaceuticals, cell and gene therapies, monoclonal antibodies (MABs), vaccines and biosimilars.

Visit Website
USEFUL LINKS
  • Home
  • Contact us
  • Imprint
  • Data Protection
  • Terms and Conditions
RECENT TWEETS
PharmaLexGLOBALPharmaLex@PharmaLexGLOBAL·
15h

At PharmaLex, one of our core values is expanding our global community. In March, we welcomed Japan, East Asia, and Southeast Asia into our global pharmaceutical #productdevelopment as a result of a merger agreement with Ascent Development Services.
https://lnkd.in/eGFf_AKv

COVID-19 NEWSLETTER SIGN UP

SIGN UP NOW

WHAT OUR CLIENTS SAY
  • Provided honest feedback and collaborative working solutions to obstacles

    South Korea based medium sized company
    Manager
PharmaLex
©2022 PharmaLex GmbH. All rights reserved.

ISO9001:2015 LogoEnergie Audit LogoSGS Logo

Suspicious Emails

We are aware of a number of suspicious emails about recruitment in circulation purporting to be from PharmaLex. Emails sent by PharmaLex will originate from @pharmalex.com. Should you receive an email and are unsure as to its validity, please report it to contact@pharmalex.com.

Many thanks for your understanding.

The PharmaLex Team

    Please DO NOT send us event/conference information.
    We will not respond and these will be deleted immediately.





    Select your state:

    .
    If you do not wish to receive any communication from us, you may unsubscribe at any time.

    #AskTheExpert #TogetherBEYONDCOVID19





      Select your state:

      .
      You can unsubscribe at any time at data.protection@pharmalex.com

      If you do not wish to receive any communication from us, you can unsubscribe at any time at. Click here to view our Privacy Policy.

      #TogetherBEYONDCOVID19

      We closely monitor developments and updates surrounding the current outbreak of Coronavirus Disease 2019 (COVID-19) from official sources including the World Health Organisation and are following the guidance and direction of the governments and the local authorities. We are taking this situation very seriously and our number one priority is the safety and business continuity for our customers and colleagues. As ever, we will do everything we can to ensure that services are delivered within the required time and the trusted quality PharmaLex is known for