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Lean compliance and adopting a true risk-based approach to validation
By Mark Stevens, GxPi
Word count: 1974
Overview
With the increasing need for businesses to reduce cost and demonstrate value, there is a requirement
to look at all aspects of the pharmaceutical and biopharmaceutical industry to achieve improvements
in efficiency, including how quality and compliance is managed. This article will investigate how GXP
best practice should be implemented and how lean methodologies, originally developed for
manufacturing operations, can be utilised to achieve improvements in efficiency and compliance.
Introducing Risk Assessment
Risk assessment is a frequently used term and today almost every industry sector has adopted this
as a standard working practice in some form. The healthcare industry is required to manage the
balance between increased regulation with the need to be more efficient and effective at each stage
of the drug development and manufacturing process. Both sides of this are driven by the need to
achieve continuous improvement. If done correctly and consistently, these business, regulatory and
legislative requirements can be aligned. It is important to understand what truly represents a risk to a
patient (or critical information that is ultimately associated with the care of a patient).
The process of identifying and quantifying a GXP risk within any component of the drug development
and manufacturing process is often done inefficiently, most often due to the focus of the exercise not
being correct or as well defined as it could be. In many cases, this can be due to the process being
used to conduct the risk assessment being inappropriate and / or over-complicated. The purpose of
the process is not to generate comprehensive reports, it is to identify where there is potential risk to
the patient and to eliminate or minimise this risk.
The International Society for Pharmaceutical Engineering (ISPE) Baseline® Guide and Good
Automated Manufacturing Practices (GAMP®) documentation provides an excellent foundation upon
which to base risk assessment. In order to maximise this, it is necessary to conduct an objective
assessment of each system and each activity. It is important to challenge the way things have been
done historically, as well as the way things are done in different parts of the organisation as this may
not always be the most appropriate solution.
For instance, the classification of environmental conditions for a work area can have a significant cost
impact in terms of design, installation, validation and ongoing monitoring. For pharmaceutical
companies, it is important to consider whether reducing the classification across elements of the drug
manufacturing process can have an impact on product safety. By challenging the classification
necessary in order to conduct Good Manufacturing Practice (GMP) / Good Laboratory Practice (GLP)
operations within an environment that is adequate for the operation, companies may be able to
achieve significant savings. A value engineering study must challenge all areas of the drug
development and manufacturing process, including quality and must not be restricted to new facilities,
as the robust review of existing facilities is often beneficial.
Introducing Lean Compliance
Lean compliance involves the process of clearly identifying what an organisation does to achieve
GXP compliance. This includes factors such as how the organisation measures success, what can be
measured in order to quantify success and improvement and identifying tools to seek better and more
efficient ways of either improving performance or maintaining performance with less resource. In
terms of quality and compliance, this means driving a bigger margin between the resource needed to
achieve and demonstrate the appropriate and applicable level of compliance. Using the
manufacturing analogy, improvements in efficiency can be driven through economies of scale, for
example having more products in the development pipeline or marketed products that are managed
by the quality and compliance functions. However, this presents a number of challenges as not every
company is a multi-national, multi-product organisation able to achieve savings in this way. Secondly,
larger organisations with manufacturing capabilities have already seen the benefits of applying lean
thinking to their production operations, so it is important to examine how this can be applied to other
parts of the business. In other words, how can the same level of resource be used to support an
increasing pipeline or increasing regulatory requirement or, how can a reduced level of resource
support the current level of regulatory requirement? This is represented in Figure 1 below.
Lean compliance is a means by which all parts of an organisation are aligned to contribute to
achieving optimal performance. Each component of the business process is also made truly
accountable. Lean compliance addresses the costs and return of QA compliance and how this
improves the quality or confidence in a product or process. It also questions how much effort is given
to ensuring the ultimate safety of the patient, that the applicable regulations are fulfilled and can be
demonstrated, that regulations are generally fulfilled to provide a feeling of security and that
corporate policy is adhered to.
The focus of such a process is to conduct an objective assessment of the quality, compliance and
validation functions in order to categorise each process and sub-section of a process as shown in
Table 1:
Value-adding Activity that transforms or adds value to the quality / compliance operation
Make as effective as possible
Business Value Activity that does not add value but is necessary to the business
Reduce and Minimise
Waste Activity that uses resources but creates no value
Eliminate and Prevent
Table 1: Summary of function value categorisation
In order to maximise the value of this overall process, it is essential that the focus is on the
identification and elimination of waste. As demonstrated in Figure 1, the savings of waste prevention
will typically far exceed the savings from efficiency improvements. To achieve this, it is necessary to
challenge the quality and compliance activities that the business is performing. For example, if a new
enterprise resource planning (ERP) system is to be deployed within an organisation, one must
consider which components of this actually have any GXP impact and require validation. It is
important to determine how many of the „Business Value‟ elements are truly necessary and if any can
be downgraded to waste. This approach can quickly facilitate real savings in cost and time, both in
terms of implementation and ongoing use of systems within the GXP environment. It is therefore
important that a risk assessment process not only looks to identify what is required to ensure
compliance but also enables clear identification of what is not required.
Figure 1: Lean compliance resource savings identification and cost benefit diagram
As with any quality system, the route to success involves setting out the „policies‟ to communicate
what the organisation wishes to achieve, the „guides‟ for how this should be done (principles), the
details of how this must be completed (methods) and the measurement system and expected results
by which success and adoption will be measured. Fundamental to the success of any lean
compliance programme is the buy-in from the organisation and readiness to change. This is a change
management project and must be managed appropriately – a brilliant idea will remain just that if it is
not clearly communicated and adopted with the necessary understanding of its purpose and benefit.
The objective of lean compliance is to enable organisations to focus on those elements that truly
impact upon patient safety and eliminate those that do not. If an organisation successfully adopts a
leaner approach to compliance then they will have a significant commercial advantage over
competitors.
Whilst traditional lean methodologies can be easily transposed to a manufacturing operation for a
marketed product, this is not always the case with clinical manufacture or GLP and GCP operations.
These require a smart adaptation of those tools that actually work for a „project-based‟ approach, as
there will be a level of uniqueness in each study, project and activity performed.
In order for the lean compliance process to be successful, it is essential to have the correct blend of
internal knowledge and ownership of the operations combined with the right amount of sympathetic
expertise to drive the overall success. Depending upon the size and internal capabilities of an
organisation, this may require secondment of personnel from a different business unit or the use of
third party GXP consultants. This is a people process which requires expert guidance to ensure
communication, coaching, cooperation, consistency and a collective and clear understanding of the
results and success. The roadmap to success is shown below in Figure 2.
PhilosophiesWhat drives me at work?
- Customer First
- Elimination of Waste
- Respect for the individual
PrinciplesWhat approach should we apply?
- Standardised way of working
- Continuous improvements
- Focus on the process flow
- Visual Management
MethodsWhat tools do we need?
- DMAIC, PDCA
- 5S
- Value Stream Mapping
- Visible Planning
ResultHow do we measure success?
- Clear KPI
- e.g. Cost / time benefit analysis
- e.g. Delivery performance
Figure 2: Lean Compliance process overview
Lean Compliance case study:
Lean compliance is a methodology that GxPi uses within the provision of its solutions and services. It
is built upon those same principles and processes that have been used to great effect within
traditional manufacturing industries. The following real life example demonstrates how lean
compliance can result in significant cost and time savings for the release of Clinical Trial Material
(CTM).
A lean compliance initiative has been implemented within a leading Contract Manufacturing
Organisation (CMO) in order to reduce the time and cost needed to review and release CTM. In order
to be successful, the lean compliance process was mapped, documented and explained to all key
stakeholders to create a collective understanding of the operation. Through the use of lean
methodologies, the QC / QA cycle time was reduced from 200+ days to 56 days, a reduction of 72%
of the original time taken. These process improvements were incorporated into standard operating
procedure (SOP) for release of CTM and have enabled knowledge sharing between different sites of
the CMO, significantly enhancing business processes.
Recent debate: eCTD demonstrating lean compliance?
Regulatory submissions using the Electronic Common Technical Document (eCTD) guidelines are
becoming increasingly common in the pharmaceutical industry and a greater number of national
agencies have begun to insist upon this method. Whether eCTD demonstrates lean compliance,
saving time and costs during product registration, has become a matter of debate. In a recent survey,
Pharma IQ 1 asked members of the pharmaceutical industry if electronic submissions saved time in
the laboratory. The majority of respondents said yes (62.1%) but some either did not notice a change
in time or said that time spent on submissions had increased. One respondent highlighted the need
for processes and training, saying that while managing applications electronically has given their
organisation the potential to be more efficient, it is up to the business to create, train and support
processes that can leverage the strengths the technology has to offer. Like any new method, it is
expected that the benefits of eCTD will become clearer once people are fully trained in using the
system.
Conclusion
Using a true risk-based approach to quality and compliance is an essential component of ensuring an
organisation not only fulfils its regulatory requirements but also does so with a clear understanding of
the priority and relative resource that should be given to each element. It also enables the
identification of those areas that do not have any notable impact upon patient safety or GXP data
integrity, giving justification for eliminating or ignoring these.
Lean compliance is a business process efficiency concept used to ensure that GXP best practice is
achieved as efficiently and effectively as possible. By carefully using proven and established lean
methodologies and tools, the quality and compliance functions of an organisation can be challenged.
Lean compliance establishes the true value-adding operations within a business and looks at how
these can be maximised. It decides which business value operations are necessary to ensure
compliance and how these can be simplified and reduced. It also highlights the non value-adding
operations that can be eliminated and prevented to save time and cost.
The objective is to truly challenge each component of a process and determine if it is really essential.
The main question is whether something is being validated because it has always been done that way
or because it really has an impact on quality and compliance.
The key to success with any lean compliance project is the same as any good business or project
management practice – establishing the key objectives, clear communication throughout the group,
maintaining the focus and support needed to drive success and measuring that success. Companies
such as GxPi provide access to skills and experience that can help enable lean compliance projects
but it is the energy and ideas within the organisation that are the key to delivering success.
Reference
1. http://www.pharma-iq.com/article.cfm?externalID=2928
For more information on GxPi, please call +44 (0) 115 924 8475 or email [email protected]. Alternatively
please visit www.gxpi.com for further information.
About GxPi
GxPi makes regulatory compliance leaner, by providing products and services to the biotechnology,
pharmaceutical, consumer healthcare, medical devices and veterinary industries, that are “simply
compliant”. GxPi‟s services arm delivers High Value, High Impact consulting services which cover all
aspects of regulatory compliance (GMP, GAMP, GLP, GEP, GCP, GDP), qualified person (QP),
quality assurance (QA), validation services (process engineering, computer systems, laboratory
equipment), clinical technology, training and project management. GxPi‟s solutions arm, provides
electronic Document Management solutions (eDMS) to the life sciences sector via the x-docs™
platform. x-docs™ is a new class of document management software which is powerful and practical
in enabling organisations to comply with increasing regulatory requirements. x-docs™ is easy to
configure, requires little IT support, is cost-effective for organisations of all sizes and are entirely
intuitive to use with minimal training.
For further press information please contact: Fiona Robinson, The Scott Partnership, 1 Whiteside,
Station Road, Holmes Chapel, Cheshire CW4 8AA, United Kingdom Tel: + 44 1477 539 539 Fax: +44
1477 539 540 E-mail: [email protected]