Pharmaceutical Process Design and Management
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Pharmaceutical Process Design and Management

Kate McCormick, D. Wylie McVay Jr

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eBook - ePub

Pharmaceutical Process Design and Management

Kate McCormick, D. Wylie McVay Jr

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About This Book

A quality product or service is the successful and profitable outcome of organising resources, as judged by the final customer. Every business unit needs processes in order to do this effectively; and all processes must be documented so that achievements can be measured and future improvements planned and implemented. Pharmaceutical Process Design and Management takes a step-wise approach to process management. It presents the various elements comprising a process (man, machine, materials, method and environment); it looks at quality control and quality assurance, tools for quality improvements and ways of structuring a process into discrete, fully accountable elements; it proposes that for processes to run successfully, all operators must be the initial problem-solvers; finally, it illustrates how, with the right tools, every problem can be broken down into solvable elements. Learn how to deploy a science and risk-based approach to pharmaceutical manufacturing, by taking a fundamental approach to process design and management and, as a consequence, keep your customers satisfied and your profits healthy.

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Publisher
Routledge
Year
2016
ISBN
9781317081395
PART I
Evolution of Process Design and Management

1
Why Process Management is Important

We can’t solve problems by using the same kind of thinking we used when we created them.
(Albert Einstein, 1879-1955, German theoretical physicist)

Introduction

The past 50 years of pharmaceutical manufacturing have witnessed significant and continual change in technological speed and precision. There has been an information avalanche created by the internet and high-speed computing. The global patient population has expanded and lifestyles have changed, resulting in continuous identification of unmet medical needs. A busy pipeline has produced new drug product offerings of novel compounds. The structure of the industry has also changed, with mergers and acquisitions turning competitors into colleagues. Yet for all the changes, the basic principles for managing pharmaceutical process design and management have remained constant.
Unquestionably, the overall system has become complex and chaotic, a state that is counterproductive to product consistency and profitability. It is regrettable, but not surprising, to see an increasing number of products that fail to maintain safety and efficacy profiles throughout the life of the product. In this book, we propose the application of proven techniques to simplify and organize business resources and provide accurate information for timely management of product manufacture.

Why Process?

While on the surface this book may seem like another quality programme, we depart from past texts in that we provide a framework for designing and managing processes across the whole organization, beginning with raw material characteristics and ending with release to the marketplace. In addition, we link the process of manufacturing pharmaceuticals to financial reporting considerations.
Throughout the book, we acknowledge that any single change to one process element is likely to have an effect on one or more other process elements. Process elements are intertwined and change, such as improvement, to any single element must be considered in the context of impact on the others, otherwise it is easy to fall victim to the law of unintended consequences.
This book is a blueprint for pharmaceutical companies that wish to design and manage their processes simply and effectively. Our approach is the correct application of existing tools and techniques. The time is right to simplify the convoluted business environment. By doing so, the pharmaceutical industry will be able to make safe medicines more cost-effectively using a more consistent and predictable business model.
The accomplishment of business objectives in an efficient and effective manner is not a new topic. In our industry, as in all others, each generation of business leaders hopes to discover a combination of business strategies and operating techniques to foster economic growth of the business and personal reward for themselves as well as the company’s employees. The measures of success are typically quantified in terms of net profit and safe, high-quality pharmaceuticals to meet patient needs. While these measures are certainly appropriate from a gross financial accounting and manufacturing or marketing sense, the terms ‘profit’ and ‘quality’ are far too general to foster sustained competitive advantage.
A simple, uncomplicated, resource-integrated and transparent system is the only way to assure timely process corrections when necessary. Traditional financial accounting rules mandate cost aggregation in a way that masks process cost issues at the point of occurrence through the grouping of dissimilar business activities for quarterly or annual governmental reporting. A process-synchronized managerial accounting design is necessary to overcome the effects of cost aggregation at the frontline. When a process design is no more than a group of nebulous characteristics that fluctuate to meet short-term goals and objectives on the average, the work effort is aggregated in a manner similar to financial reporting. A discretely designed process, with five defined elements, is the only way to illuminate work efforts to assure timely correction. Product consistency and profit sustainability are reserved for organizations that can accurately identify conditions outside of the planned design process and resolve the issues quickly and completely. In our experience, few organizations within the twenty-first-century pharmaceutical industry have realized this state of operations.
Designing for process excellence is a simple and straightforward task, which requires integration of three general considerations to be successful:
• proper understanding of system capacity range – often referred to as the relevant range;
• system designers with hands-on experience and theoretical understanding;
• effective controls that are consistent with a statistical model of the process.
Simplicity of process configuration cannot be stressed enough. Without this key consideration, the overall control of product quality will be lost amid the chaos of today’s digital media explosion in a globally competitive world.
Consider, for example, Toyota and the numerous recent recalls. Until two or three years ago, Toyota was considered the undisputed leader of process and quality excellence in the automotive industry. However, in the last quarter of 2009 and into 2010, the company temporarily stopped sales of vehicles and conducted major recalls. During the year, the list kept on expanding. The inevitable conclusion was Toyota had quality and process problems. The underlying issue involved Toyota’s single-source supply experiencing a catastrophic closure. The event forced the company to seek a second source of accelerator pedals. Unfortunately, the replacement parts were not functionally identical to the original and would sometimes cause the car to accelerate uncontrollably.
A key reason for Toyota’s problems was a complex management system which obscured the problem and slowed implementation of the appropriate solution. In the context of this book, the process design had flaws in three areas: materials, methods and environment. The accelerator pedal assembly – materials – from a new second source supplier was discovered to fail during operation. Methods may have lacked sufficient sensitivity to identify key differences between the parts and if differences were identified, they were considered insignificant to product performance. Finally, the cultural environment hindered timely and accurate assessment of the accelerator problem, leaving Toyota faced with customer complaints, recalls and US Congressional inquiries into product safety.
Historically, process design has not been directly considered in the development of a pharmaceutical product. Rather, end-product quality control inspection requirements, imposed by governmental regulations, were meant to ensure high standards of the final product. Process design efforts have been historically directed towards the standardization of finished goods or the classification of defective materials and accountability; enforcement was limited to civil or criminal prosecution for poor craftsmanship (Juran 1998). In other words, the legacy of process management has centred on controlling pharmaceutical quality through inspection or other means such as governmental penalties.
Traditionally, the control of quality relied on extensive hands-on training through apprenticeship programmes. This approach developed a complete skillset related to the successful manufacture of a finished product. In the custom furniture industry, for example, the artisan – man – understood the impact of moisture on a particular species of wood – material – for construction and finishing purposes; the artisan provided designs that allowed proper tolerances for potentially destructive movement due to humidity-related changes of size – method – and learned of the need for razor-sharp saws or chisels – machine – to maximize ease of construction, minimize safety hazards and optimize the appearance of the final product. Attention to the environment was limited at best to personal tolerance of temperature fluctuations and a general understanding of gross toxic effects of certain types of wood. The process was an artisan with a virtually complete set of process skills contained within one individual, especially as the skills pertain to process mastery of materials, methods and machines. The experience gained during the apprenticeship period resulted in a merger of contextual understanding of the critical theoretical factors required in order to consistently meet all expectations for product performance. Further, the apprentice developed expertise through repetition.
Contextual understanding is defined as the iterative knowledge gained through the combination of theoretical understanding and direct work experience. In the modern pharmaceutical industry, it is a challenge to locate contextual understanding in the public domain, as little work experience is published. In fact, we have observed that experience is a key element missing in many of our companies today. This is particularly true where rationalization programmes have led to high numbers of redundancies among the older, more experienced employees or where technology transfer has not been recognized as a critical element of a factory closure project. In one case, we observed a complicated manufacturing process for an oral suspension being transferred from one site to another. Little or no attempt was made to capture or transfer the experience of the original workforce and, as a consequence, there were significant start-up problems in the second site.
Designing processes is not a complex activity; it is simple, straightforward and basic. Those assigned to design processes must strive for simplicity and transparency. The relevant theoretical techniques for designing and running agile commercial processes are published and well known and are not the subject of this book. From this perspective, few new concepts can be offered. Our purpose is to present process design and development from a new perspective that integrates diverse and sometimes forgotten concepts in a new and novel manner. By considering our prospective process design approach of new and old principles, a pharmaceutical manufacturing company can achieve agile process design and responsive operational management. It can move away from a rather sophisticated array of final product inspection programmes, the results of which tend to be transient in nature and short-lived.

Universal Principles of Process

Four outcomes may be expected when using the process modelling technique described within this book:
• process-related organizational chaos will be reduced;
• process deviations will become apparent and have a specific, resolvable root cause;
• process data will become more accurate when used for predictive estimations;
• actual product characteristics will closely align to the intended product characteristics.
In other words, results will be timely, accurate and authentic. It is our observation that process design is often considered to be synonymous with ‘in vogue’ quality programmes, such as Total Quality Management (TQM), Six-Sigma or Quality Circles. Stated differently, some organizations believe that if they implement a six-sigma programme, let us say using only certified black belts, that the final result will be the total elimination of problems. However, repetitive and continuing problems across the pharmaceutical industrial landscape in the form of recalled products would suggest that this approach is not universally successful.
Designing for process excellence should and does incorporate current quality techniques as one aspect of the methodology (one of the five elements in process design). However, it cannot be said that widespread use of current quality tools alone on an existing process will necessarily lead to product excellence. Well-conceived process designs will always produce quality product, but quality product can also be made using a poorly designed process where employees have learned to overcome systemic flaws for the most part. It is just that the cost of reject inspection and recalls associated with poorly designed processes happens to be extraordinarily large. The historical response to this fact can be observed with a simple review of the quality techniques that have been implemented since the early 1980s, such as Zero Defects, Quality Circles, Six-Sigma or Lean. Each programme was heralded as ‘the one’ way to fix product problems and reduce cost. Legacy techniques such as histograms, run charts and control charts were deemed less effective or boring and were subsequently put aside.
All too often, business leaders rely on academic research or the latest ‘breakthrough’ business article to meet short-term aims. While academic theory and industry legends may hold key insights, one important building block, pragmatic implementation of the basics, is often somewhat lacking or missing altogether. Pragmatic process management is mundane and deals with tedium, facts and countless simple effective problem resolutions. Academic research and ‘breakthrough’ cost containment are exciting, thrilling and make for lively discussions at business conferences. But experience shows these approaches to be transient in nature. In the past 30 years, we have watched, and even participated in, many of the programmes listed above: in each case, we have aimed at the same benefits – faster time to market, reduced wastage, lower inventories, higher productivity, etc. The presentation slides being shown today mirror exactly those we saw in the 1980s. Our industry does not appear to have advanced significantly as a result of all the different approaches.
Are the operational and financial results as suggested in this book consistently achievable as a long-term strategy? We believe so. In an era of instant digital data, when time-to-market pressures have been elevated and accelerated as the number one priority, decision information is being blurred to the extent that actual results and chaotic noise may look the same. The organization that responds to noise will be unknowingly heading towards premature failure or loss of market share.
We believe it is time to re-evaluate the implementation of simple, time-proven fundamentals that have been pushed into the background for any number of reasons. We will not research the myriad root causes for passing over the simple common-sense approaches; the reasons are not relevant other than to define the boundaries of what works and what does not work. Rather, we will dust off process basics and show them in a new light.
Lessons in principle, which were developed through careful observation and trial and error, form the basis of our model. Process knowledge troubleshooting tools most closely associated with after-the-fact problem resolution, such as the Ishkawa or Fishbone Diagram (Ishikawa 1986), will find use in the initial design of the process. In other words, our approach integrates time-proven design principles in a holistic, understandable, novel and straightforward manner.

Revolutionary Thinkers on Process

Of the significant numbers of astute observers over the centuries, we wish to focus on a group of revolutionary thinkers whose simple messages have been overlooked or even misunderstood. We chose this grouping for one reason: each individual carefully studied and observed process outcomes over a significant number of years before distilling their wisdom in published form. This is a significant departure from today’s fast-paced chaos. As stated earlier, few of the ideas presented in this text are process revelations. Rather, we choose to consider and combine diverse insights for a novel way of defining process management practices. The philosophies of the thinkers presented in this text are relevent to successfully p...

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