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Cover Story
Improving Operations Through
Electronic Batch Records
Bob Lenich
Electronic record keeping can save effort and money.
Director
Data Management Services and Solutions
Emerson Process Management
P
harmaceutical companies are of- in pharmaceutical manufacturing can be
ten on the cutting edge in terms a decided advantage. This article will ex-
of research, but when it comes to plain some of the problems caused by the
manufacturing they are, in many historic paperwork approach, and point
ways tied up with paper. Regulatory re- the way to newer methods and tools that
porting burdens have historically driven improve efficiencies, reduce delays and im-
complex procedures and paperwork in prove revenues.
order to ensure compliance. Once estab-
lished, companies tend to stay with these The Problem
systems even though there are significant A significant problem with historic
efficiencies to be gained by exploring other paper-based systems is that managing the
methods. paperwork takes a great deal of time and
Establishing these benefits are especial- effort, and has substantial financial impli-
ly important in world areas, such as Asia, cations on pharmaceutical manufacturing
where the impact of global regulatory con- operations. For example, while corrective
siderations is relatively new, and institut- actions and associated problem resolution
ing a more efficient compliance culture are being completed, significant inventory
ER0091-July08
(Source: Emerson Process Management)
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Cover Story
of Active Product Ingredients (API) can
remain in a warehouse while all analyses
and documentation reviews are completed
and approved. That product sitting in the
warehouse represents working capital tied
up, fewer inventory stock turns, and lost
profits.
What is needed is a way to eliminate
the paperwork and optimize the paperwork
process: converting to Electronic Batch
Records (EBR). They will electronically
capture and improve workflow activity,
replace paper logbooks, keep track of eve-
rything that has affected a batch, manage
the approval process, and more. Utilizing
EBR would have a dramatic impact on the
process of releasing active pharmaceutical
ingredients if it did no more than provide
better paper handling and record keeping.
Improving workflow management and in-
formation flow can dramatically improve
quality, throughput and reduce manufac- Figure 1: A fishbone diagram is an excellent tool to evaluate None-Value-Add (NVA) activity.
turing costs while satisfying regulatory re- (Source: Emerson Process Management)
quirements.
Harmonization of Regulations
While there are differences among
countries in specific regulations, a fair
amount of global harmonization has al-
ready taken place. The International Con-
ference on Harmonization, which today in-
cludes 33 countries, has aligned many key
elements of Good Manufacturing Practices
(GMP). These harmonized GMPs require
ensuring the approved production process
is followed, the right materials are added
correctly, the equipment is properly cali-
brated, the operating environment is prop-
erly controlled, and the operator is quali-
fied to perform the required tasks.
The historic answer to these regula-
tions was to utilize a paper-based manage-
ment process. However, most countries
have changed their reporting requirements
such that electronic signatures (and there-
fore electronic records) are legally binding.
Chinas acceptance of electronic signatures
as legally binding for e-commerce is one of
the latest examples of this trend.
How Far We have to Go
A benchmarking study published in the
July/August 2004 issue of Pharmaceutical
Engineering showed that the UK pharma-
ceutical industry compared poorly to an
award-winning company in that country
and even worse when compared to world-
ER0091-July08
class benchmarks. For example, a typical (Source: Emerson Process Management)
pharmaceutical company managed three
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Cover Story
to five stock turns per year, compared to telling number was cycle time in hours: arrangement can be found in the Instru-
14 for the award-winning company, and 720 hours for the typical pharmaceutical mentation, Systems and Automation Soci-
50 for world-class benchmarks. Right First company and 48 hours for the award win- ety or ISAs S88 and S95 standards, which
Time (RFT) percentages were 85 to 95 ner. The world-class benchmark was eight cover batch production, and the architec-
for the typical pharmaceutical company, hours. Switching to EBR can deliver signif- ture of information flow among the plant
96 for the award-winner, and 99.4 for the icant improvements in this performance. floor automation systems and enterprise
world-class benchmark. Perhaps the most A good idea of the shape of the ideal resource planning applications. All of this
should be found in a good EBR.
Components of the Ideal System
Todays integrated EBR systems can be
applied from one end of the plant floor to
the other, including the facility design and
day-to-day maintenance. A representative
EBR system includes components for the
following:
A security and audit component that
addresses 21 CFR Part 11 concerns
for electronic records and signatures,
and provides audit trail services of all
production and operations activities for
all modules in the system.
A content repository that provides
controlled access to manufacturing
documentation, and gives the company
full control of all documents and version
information.
A training and development function
that manages training courses and
comprehensive training records,
Figure 3: Root cause analysis of cycle time deviations. including the tracking of GMP training
(Source: Emerson Process Management) courses, scheduling of personnel, and
real-time status confirmation of operator
qualifications.
An equipment tracking function that
maintains the facility equipment hierarchy
model, documents equipment states and
properties, and tracks definable equipment
events like usage, cleaning, and maintenance
in any manufacturing environment. It
should provide paperless calibration records
and equipment logbooks with real-time
updating.
A materials management module that
provides both work in progress and centralized
material management capabilities with
container level tracking, material genealogy,
and quality controls.
A weigh and dispense function that ensures
the proper material has been measured,
containerized, and then added at the correct
time during the order.
A modular recipe authoring function
that simplifies and speeds the process of
generating documents and workflow such
as batch records, test methods, validation
Figure 2: Cycle time deviation during batch production. protocols, and other manufacturing
ER0091-July08
(Source: Emerson Process Management) documents.
Configurable electronic workflow that man-
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Cover Story
ages and sequences batch records, collects
Table 1: Examples of typical measurement. and consolidates all batch data and gener-
ates facility performance metrics, graphs and
charts.
POTENTIAL IMPROVEMENT/ An electronic batch records module that
CATEGORIES CURRENT STATE
FUTURE STATE
provides routing, review and approval of
Quality paperless manufacturing records for current
good manufacturing practices (cGMP)
Deviations Deviations/lot Percent reduction facilities with complete product and activity
Investigations Investigation efficiency Percent improvement in efficiency genealogy.
A scheduling module that provides real-time
On Spec Results Percent right first time Percent improvement production scheduling and updates so that
Correct/Complete Batch Records Percent right first time Percent improvement plant floor events and equipment changes
can be immediately accommodated
Number of deviations due
Training to Comply Percent improvement Easy integration to all existing plant floor
to deficient training
systems and connectivity to high level
applications such as Enterprise Resource
Planning.
Throughput
Yield on process/unit ops Percent yield/unit operation Percent improvement Where to Begin
Variability in critical quality
A good way to begin to develop an EBR
Repeatability (reduced variability) Variability reduction system is to benchmark current or planned
attributes and batch yield
workflow through Six Sigma and Lean Manu-
Unit cycle time Percent improvement facturing techniques. This evaluation will pro-
Reduced cycle times
Batch cycle time Percent improvement vide many opportunities to gain efficiencies.
Excellent tools, including Fishbone Diagrams
and Value Stream Maps, can be effectively
Availability used to evaluate Non-Value-Added (NVA)
activities (see Figure 1).
Percent downtime Percent improvement and
Reducing unplanned shutdowns Examine the roles of equipment, people,
equipment and line increased production revenue
materials, documents and existing informa-
Improving equipment status
Manpower to get information FTE reduction
tion. Using these benchmarks it becomes a
management (clean, calibrated) straight-forward task to see where improve-
Percent planned cleaning ments can be made and, just as importantly, to
Reduced cleaning time and setup time Increased production revenues
and setup time quantify the results.
Examples of typical measurement are in
Reduced changeover Percent planned changeover Increased production revenues
Table1.
Improved planning Manpower to get information FTE reduction
Example
Recent experience with a major pharma-
Operation and Maintenance ceutical site confirms these benefits. This site
has shown significant deviations in overall
Eliminating NVA activity (in operations,
compliance and maintenance)
Hours reduction/improvement cycle time, as shown in Figure 2. Root cause
analysis of the deviations shows various causes,
Reduced overtime (in operations, Overtime hours reduction/ with the largest cause being operator error, as
compliance and maintenance) improvement
shown in Figure 3. Resolving the deviations
Manpower efficiency improvement Hours reduction/improvement during the release approval process is the larg-
est component of the cycle time variability.
Implementing an EBR system has reduced
Capital the deviations by more than 20%. Cycle time
variability reduction has also seen significant
Reduced WIP (normal production) Current WIP Cost reduction
improvement.
Fast time-to-market (new Current calendar from
Time reduction
capital projects) design to conformance lot Conclusion
Current cost from design
The opportunities are real and significant.
Reduced cost of new capital projects Cost reduction Taking advantage of changes in regulations
to conformance lot
and leveraging new technology such as EBR
ER0091-July08
(Source: Emerson Process Management) systems are making pharmaceutical manu-
facturing more competitive. PA
PharmaAsia June July 2008
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