Integrated, modular, scalable and
CFR 21 Part 11 enabled
OPTIMIZE WEIGHING AND DISPENSING OPERATIONS USING ELECTRONIC DATA CAPTURE (EDC)
By Jim Sexton, Vice President of Marketing, Rice Lake Weighing Systems
It has been estimated that 50% of all the people in the United States file their taxes electronically. Since
electronic filing is relatively new, how did so many people migrate from manual filing to electronic filing?
What does this mean?
A common adage says that in this life, only two things are certain: death and taxes. Historically, the
annual tax deadline of April 15 in the United States is nothing short of pandemonium with a government
imposed deadline.
The US government has found a way to motivate its citizens to embrace electronic filing. By filing
electronically, those who are due a refund receive it faster than those who file by US mail. If the
government can find a way to entice people to adapt to a new, more efficient way of completing important
tasks, like filing taxes, why hasn’t industry found a way to adapt to new, more efficient ways of completing
important tasks?
Electronic Data Capture (EDC) is the process of collecting data electronically. Generally speaking, EDC
streamlines, replaces or significantly modifies the existing paper-based system in the United States.
Ultimately, the goal is to store data in a centralized data storage repository – safe, secure and redundant
with real-time access.
Drug prices are significantly higher in the United States than in other parts of the world. More and more
US citizens are flocking to countries like Canada and Mexico to get their prescription drugs filled. This is
due in part to all of the research and development performed in the US. This is expensive and drives up
the drug costs. Also, other countries don’t regulate the approvals process to the degree the US FDA
does.
Recent trends that influence the need for operational excellence in the pharmaceutical industry include 1:
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Real market growth is slowing
Pharmaceutical shareholder returns are decreasing
Drugs make a net profit on average of 19% (versus 7.5% for the rest of the S&P 500)
High research & development (R&D) expenditures
It takes 9 years to fully develop and market a new pharmaceutical
Market drivers
Several issues are driving the pharmaceutical market. These “market drivers” include:
 18 major drugs will come “off patent” this year
 4,400 new drugs are in the development pipeline
 “Big pharma” must launch anywhere from $300M to $500M or more per year in projected revenue
drugs just to survive
 Development costs approach $1B for a single drug; typically, only 30% of this is recouped
 Litigation totals in excess of $10B
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Dr. Bruce Maloff, Accelerating Drug Development Expectations and Opportunities utilizing Electronic Data Capture (EDC)
Odds of FDA Drug Approval
Lab Animals
1:10,000
Safety Dose
1:10
Pre-Clinical
Phase 1
Efficacy
1:5
Long Term Effects
1:2
FDA Review
1:1.5
Phase 2
Phase 3
Phase 4
“Significant potential and need exists for improving the efficiencies of pharmaceutical manufacturing and
associated regulatory processes.”2
Technological opportunities (e.g. Process Analytical Technology or PAT) are available for realizing this
potential. However, industry is reluctant due to regulatory uncertainties. PAT provides an opportunity to
move from the current testing and document quality paradigm to a continuous quality assurance
paradigm. This paradigm shift could greatly improve our ability to ensure quality is “built-in” or is “by
design”. This is the ultimate realization of cGMP or current good manufacturing practices 3.
Process Analytical Technology (PAT) is a system for designing, analyzing, and controlling the
manufacturing processes based on two principles:
1) understanding of the scientific and engineering principals involved; and
2) identification of the variables which affect product quality4.
The PAT initiative is consistent with the current FDA belief that quality cannot be tested into products, but
should be built-in or by design. According to the FDA draft guidance, the desired state of pharmaceutical
manufacturing is that:
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product quality and performance are ensured through the design of effective and efficient
manufacturing processes
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product and process specifications are based on a mechanistic understanding of how
formulation and process factors affect product performance
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quality assurance is continuous and real time
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relevant regulatory policies and procedures are tailored to accommodate the most current
level of scientific knowledge
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risk-based regulatory approaches recognize both the level of scientific understanding and the
capability of process control related to product quality and performance
The primary goal of PAT is to provide processes that generate products of predetermined quality. In so
doing, improved quality and efficiency are expected from:
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reduction of cycle times using on-, in-, or at-line measurements and controls
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prevention of reject product and waste
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real time product release
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increased use of automation
Dr. Ajaz S. Hussain, FDA Director Office of testing and Research, May 8, 2002
For more information on this topic, see the website-www.cgmp.com
4
www.fda.gov
3
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facilitation of continuous processing using small-scale equipment, resulting in improved
energy and material use and increased capacity
Tracer Pharmaceutical and Dispense Optimization Matrix5
Regulatory
Compliance
Production
Planning and
Scheduling
Quality, PAT,
Corrective and
Preventive Action
(CAPA) Audit
Trail
Electronic Batch
Record (EBR)
21 CFR Part 11
Remediation
Plant
Warehousing
Optimization
WEIGH AND
DISPENSE
SOLUTION
PREPARATION
COMPOUNDING
FILL FINISH
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Traceability weighing and dispensing optimization systems represent a comprehensive solution to reduce
drug manufacturing costs, increase productivity and efficiency, improve time-to-market and drive
regulatory compliance.
Traceability systems optimize weighing and dispensing by reducing validation efforts and enabling 21
CFR Part 11 compliance. “Tracer” is a co-branded traceability system developed by Rice Lake Weighing
Systems and UK-based Stevens Group. This system is modular, open-architected, and scalable to
several thousand clients. Tracer’s embedded diagnostics ensure repeatability and proactive event
management if there is a problem with the network or components (e.g. balances, scales, printers,
thermometers). Tracer easily becomes the “traffic cop” for integrating micro-analytical lab balances, top
loaders, bar-code readers, printers, and precision floor scales networked on the manufacturing floor. It is
intuitive and has a large easy-to-use color Human Machine Interface (HMI) including impressive graphical
displays. An extensive library of API links to ERP/MRP system is available. The system has previously
been linked to SAP and JD Edwards.
In detail, Tracer reduces validation through:
 Extensive, pre-defined macro functions and ingredient formulations
 Precise weighing and dispensing
 GAMP4 project methodology6
 Making a full audit trail available
 Standard documented test specifications and real time embedded diagnostics algorithms
Further, Tracer is 21 CFR compliant by virtue of integrating:
 Electronic signatures
 Electronic record of materials, personnel and equipment
 Strict version and document control
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Rockwell Automation Encompass partner Rice Lake Weighing Systems
ISPE
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Impenetrable security with built-in redundancy
Audit trail
Business record archiving
Signature/record linking
Multi-tier security levels
Tracer is modular, scalable and open:
 ERP/MRP and WMS integration via API – 1000’s of references globally
 Standard support for any make or brand of balance/scale apparatus
 Integration with hand-held bar code scanners and RFID “Smart Label” printers
Productive and Efficient Business Process Workflow
Tracer ensures batch uniformity time after time through:
1. Accuracy and documentation of material additions
 Calculation of quantity of active ingredients based on desired potency
 Consistent tolerance checking
2. Traceability
 Assures materials are quality approved prior to production
 Real-time inventory control
 Captures lot, sub lots, containers and material properties for each production order
 Accurate, auditable and readily available records of material, equipment, production order,
formulation and batch personnel
3. Improved business process workflow efficiency
 Standard, electronically managed work instructions
 Increased visibility of plant operations top to bottom
BENEFITS OF A TRACER SYSTEM
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Reduces risk and waste/real time inventory
Improves consistency of quality
Improves operations efficiency/productivity
If you are considering a traceability investment, please contact Glenn Zalusky at Rice Lake Weighing
Systems and discuss a site audit. Glenn can be reached at 800-472-6703, ext 5165.
This paper was produced by Jim Sexton, vice president of marketing for Rice Lake Weighing Systems in
Rice Lake, WI. Jim received his Bachelor of Science degree in Business Administration from Ohio State
University in Columbus. Jim also holds a MBA from the University of Tampa. Jim can be reached at
jim.sexton@rlws.com.