180 N Riverview Drive No. 300Anaheim, CA 92808United States

+1 714 996 5302marketing@parsec-corp.comwww.parsec-corp.com

TM

Tackling the Challenges of Pharmaceutical

Manufacturing

By nature, pharmaceutical manufacturing operations are complex, inefficient, and consequently costly. Due to the inherent complexities, the cost of poor efficiency and its root causes are often not well understood by many manufacturers.

Introduction

Contrary to what may be perceived—in most cases—the cost of manufacturing operations significantly exceeds that of research and development. It is imperative to continuously identify the root causes for poor efficiency, classify and rank opportunities for improvement, and to undertake corrective measures to increase the productivity of manufacturing operations.

Kaizen programs use a blitz approach to identify and fix problems quickly. They tend to focus on equipment-related issues and as a result, they are simpler to undertake with faster, localized results.

Continuous

have a defined strategy, valid methodology, and the right process analytical tools. Many pharmaceutical manufacturers have adopted methodologies such as Kaizen, Lean, and Six Sigma as part of their continuous improvement initiatives.

Kaizen programs use a blitz approach to identify and fix problems quickly. They tend to focus on equipment-related issues and as a result, they are simpler to undertake with faster, localized results.

Lean programs tend to focus on topics such as value stream mapping, logistics, waste and cost reduction, inventory management, and cycle-time improvement. Lean programs are typically of medium complexity and require more time and broader reach than the Kaizen approach.

Six Sigma programs use statistical tools and focus on reduction of variability. Typical goals are prevention of defects, improving predictability, and achieving process excellence. These programs are often complex, require significant time investment, and have a broad scope.

Without methodical, continuous, improvement initiatives in place, elevating efficiency in a meaningful fashion is unlikely. Although many manufacturers have active continuous improvement programs in place, many are not reaping the expected benefits largely due to:

• Absence of a committed culture and a defined strategy.

• Unattainable expectations and bad assumptions.

• Insufficient training.

• Poor visibility to accurate, timely and actionable data.

• Focusing on treating the symptoms of inefficiency.

• Lack of understanding of the root causes.

• Unavailability of relevant, real-time, performance indicators on which to base decisions.

• Singular focus on equipment instead of overall production process.

• Inadequate understanding of process variability.

Arguably, continuous improvement is a major goal of PAT. Successful continuous improvement programs must

Knowledge Management and Decision Support Tools

Once an organization has determined their strategy and methodology for continuous improvement, it is imperative to select the right knowledge management and decision support tools. This is not necessarily a simple task; quite often, the existing business systems and manufacturing operations infrastructure are complex and involve incompatible technologies, legacy systems, multitude of suppliers, disjointed connectivity, and insufficient security.

Ideally, the chosen tools:

• Must work regardless of methodology selected for continuous improvement. Best practices often require a hybrid approach.

• Won’t require changes to the existing infrastructure, and must work with existing systems and processes regardless of make, model, vintage.

• Can be deployed quickly and economically without disrupting production and must be non-intrusive.

• Comply with regulatory requirements (e.g., 21 CFR Part 11) and remove regulatory uncertainty.

• Can effectively identify factors affecting quality and performance. Scientifically

determine and rank the root causes for poor quality and performance.

• Provide the type of quality and process improvement recommended by PAT. Making it possible to bring about innovation while managing risks.

• Won’t add complexity disproportional to benefits: Easy to use and manage by those it’s intended for.

• Must be scalable, to allow extensibility commensurate with needs, and localized to the enterprise.

• Must provide the needed intelligence for effective decision making. Poor decisions based on poor information often lead to poor performance.

Process Analytical

system: quality cannot be tested into products, it should be built in or should be by design.

There are many current and new tools available that enable scientific and risk-managed pharmaceutical development, manufacturing, and quality assurance. These tools, when used within a system, can provide effective and efficient means for acquiring information to facilitate process understanding, develop risk-mitigation strategies, achieve continuous improvement, and share information and knowledge. in the PAT framework, these tools can be categorized as:

• Data acquisition and analysis tools.

• Process analyzers or process analytical chemistry tools.

• Process monitoring and control tools.

• Continuous improvement and knowledge management tools.

Effective, continuous improvement programs must leverage subject matter experts, involve cross-discipline teams, use analytical tools, follow best practices, and regularly execute corrective actions.

The US food and drug administration (FDA) has defined a framework—referred to as Process Analytical Technology (PAT)—that promotes voluntary implementation of innovative pharmaceutical development, manufacturing, and quality assurance.

Specifically, PAT is a system for designing, analyzing, and controlling manufacturing through timely measurements (i.e., during processing) of critical quality and performance attributes of raw and in-process materials and operations, with the goal of ensuring final product quality.

According to the FDA, the goal of PAT is to understand and control the manufacturing process, which is consistent with the current drug quality

An appropriate combination of some, or all, of these tools may be applicable to a single-unit operation, or to an entire manufacturing process and its quality assurance.

TrakSYS™ by Parsec is a leading real-time decision support solution that is widely used by pharmaceutical companies to measurably improve asset utilization and productivity. TrakSYS™ is a Service-Oriented Architecture (SOA) application with various components specifically designed to meet the varying needs of users and their unique operational excellence goals.

TrakSYS™ takes the guess work and reliance on intuition out of the decision-making process by providing the required information to the right people—when they need it—regardless of where they are located. By analyzing the impact of a multitude of variables across the value chain on product quality, yield, schedule compliance, goal attainment, and cost, TrakSYS™ empowers the stakeholders to make fact-based decisions that will often deliver on the promise of quality by design.

Ensure Product Quality and Performance with TrakSYS™

Figure 1 - Cost Benefits of a Software Solution

of poor quality attributable to their responsible operations in a timely manner so that improvements will be made to avoid costly losses.

With TrakSYS™ you can expect:

• Innovation that delivers on its promise without regulatory risks, no business or production disruption, and infrastructure independent.

• A responsive and proactive workflow with repeatable good results (lower variability).

• Better Decisions, managing expectation, avoid costly assumptions, don’t simply rely on intuition.

• Improved performance visibility into; internal resources, assets, suppliers, procedures, and materials.

• Increased internal rate of return (IRR), yielding better asset utilization.

• Lower total cost of ownership (TCO) with reduced IT cost to support software.

• Decreased cost of finished goods manufactured (COFGM). Much better quality and higher yield.

• Reduced labor, reduced materials and energy costs, higher on-time completion of quality goods, faster cycle times, lower materials cost, and smaller carbon imprint.

• Improved profitability, create a competitive edge for better shareholder value.

TrakSYS™ non-intrusively gathers the raw data from various sources in real-time. The gathered data is then processed through the configurable and rules-based analytics and then the resulting, personalized intelligence is securely distributed in real-time to the authorized users.

TrakSYS™ effectively models and analyzes the various aspects of the manufacturing process and delivers the findings sorted by rank/impact, discipline, and criteria selected by individual users. This targeted delivery of pertinent information avoids information overload and enables the recipients to focus their decisions to get the most positive impact relevant to productivity and quality enhancement. Ultimately, the workflow is transformed from the usual reactionary practice to a proactive (and preemptive—if warranted) doctrine that inherently supports quality by design. Consider the challenges associated with sustainable quality improvement.

What are the root causes for bad quality? Are they design related? Could they be because of third-party supplies (e.g., components, ingredients, services, etc.)? How about procedures? Would equipment play a role in the quality? What about personnel training? The bottom line is that there are many variables that will absolutely affect the final quality. In order to consistently and effectively manage quality, the adverse impact of all these variables must be assessed continually. Also, the stakeholders must be kept informed of the root causes

TM

About Parsec

Parsec is the developer of TrakSYS™, a proven operations management software application and solution platform designed to significantly improve manufacturing processes. Parsec is committed to providing best-in-class products and solutions to our worldwide community of clients to assist them in optimizing their manufacturing operations. There are thousands of TrakSYS™ licenses in use around the globe in a wide variety of Industries.

TrakSYS™ helps manufacturers to maximize asset utilization and efficiency, increase capacity with no new capital equipment, reduce production costs, decrease lead time, and improve profitability. For more information about Parsec and TrakSYS™ please visit the corporate website at www.parsec-corp.com.

Copyright Parsec Automation Corp. 2016 All trademarks are the property of their respective owners