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Bob Rhoades
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Against a backdrop where as many as 40 per cent of all drugs taken by Americans are imported, and some 80 per cent of the active pharmaceutical ingredients in those drugs come from foreign sources,1 it is not hard to see why the US Food and Drug Administration (US FDA) is increasing its focus on inspections in emerging markets. India – which has about 200 FDA-approved manufacturing facilities – is the largest exporter of medicines to the US, supplying some 40 per cent of generics and over-the-counter products and around 10 per cent of finished dosages. The country’s drug exports to the US totaled $4.2 billion in 2012, an increase of almost one-third on the previous year2.
The recent crop of warning letters issued to Indian companies is a direct result of this heightened FDA activity, and a reminder of the essential nature of regulatory compliance. To date in 2013, Indian manufacturing plants have received 13 import alerts, compared with seven in China and two each in Australia, Canada and Japan. To protect the market share and reputation of India’s biopharma sector, rapid achievement of baseline compliance – far beyond simple documentation of processes, and instead reflecting true, real-time information about the specifications and compliance of every batch – is essential. This will build the foundation for sustainable, best-in-class compliance practices.
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8 pillars of an effective quality system
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From over 30 years of experience in advising on quality and compliance issues, India is by no means alone in facing compliance challenges. In other emerging and developed markets, economic uncertainty and industry consolidation are forcing biopharma and device companies to do more with less. Without the right attention, systems and processes can weaken, domain and critical thinking expertise can erode, and core quality principles can be neglected, leaving companies vulnerable to compliance lapses and enforcement action.
In today’s heightened regulatory environment, even traditional compliance – where quality assurance and compliance are backroom cost centres – is insufficient. However, good leaders realise that quality and compliance are the ‘tickets to play’ in the global healthcare products space. Enlightened leaders know that best-in-class compliance is an opportunity for market differentiation. By applying systems-based thinking and aligning compliant quality systems with key business processes, practicing the art of compliance, even greater rewards are possible. Such strategies facilitate sustainable compliance as well as systematic, data-driven medical product development.
Traditional compliance: Complex procedures, point polutions
A traditional compliance approach is often distinguished by a complex array of quality policies, standard operating procedures, and work instructions that may bear only passing resemblance to the way work actually gets done. Although the good manufacturing practice (GMP), good clinical practice (GCP) and good laboratory practice (GLP) regulations require some 200 procedures, it’s not atypical for biopharmaceutical companies to have thousands of such procedures. Paradoxically, while a complex network of procedures is designed to compel consistency and compliance, without careful attention, procedural complexity is more likely to result in non-compliance and inefficiency.
Another traditional compliance approach is to rely on reactive, point solutions to address problems. Point solutions typically flow as follows: find a problem, add a procedure, and fix only that problem. Historically, the prescriptive nature of approval and GMP requirements inadvertently reinforced companies’ reluctance to make systemic changes to products or systems, favouring use of more focused point solutions. But point solutions tend to fix symptoms rather than systemic causes. They similarly falter when they do not address the same issues that may be present elsewhere in the company.
The confluence of point solutions with complex procedures makes it impossible to achieve sustainable compliance — with interlinked processes and systems that help an organisation respond to problems, maintain compliance, and prevent non-conformities from occurring. The FDA’s approach to sustainable compliance involves eight pillars (Figure 1).
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Where is your comapny on the compliance maturity curve
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FDA’s focus on supportive management as one of the eight pillars of an effective quality system underscores a principle implicit in the current philosophy of global regulatory bodies.
Consequently, it is both a strategic and sustainable compliance imperative that management teams of today’s healthcare product companies fully engage in their organisation’s quality management and compliance activities.
Moving up the compliance maturity curve
How does a company move compliance from a baseline, traditional approach to a fully effective quality system that is not only compliant but efficient and integrated to key business processes? Think of this in terms of a compliance maturity curve, with four stages of maturity (Figure 2).
At Stage 1, companies have complex, ineffective and impractical quality systems that are typically broken and in fire-fighting mode. Stage 1 companies are reactive and continually remediating processes that don’t work.
Companies at Stage 2 are slightly ahead on the curve. They are more likely to make timely and effective fixes, but all too often slide back down the curve as their processes get increasingly complex or their solutions are not sufficiently systemic.
At Stage 3, a company has an effective, fully functioning and compliant quality system. When done right, the same methodology used to achieve Stage 3 compliance can be taken to Stage 4, a process-driven and sustainable compliance framework integrated with business processes to facilitate business effectiveness, efficiency, and innovation.
Stage 4 is distinguished by applying critical systems and process approaches not only to quality systems, but to other key product development activities and business decision making. Management input and oversight is critical to ensure Stage 4 success. To reach stage 4 sustainable compliance, companies must use a three-step approach involving Assessment, Solution Design, and Implementation (Figure 3).
Step 1: Assessment
Begin with an objective, rigorous assessment of the current situation. Enlist the best critical thinkers and problem solvers in your organisation, or get experts to help. The assessment should include:
Identify and prioritise gaps
Regulatory requirements are constantly changing. Identify the risk areas where processes are not sufficiently robust to consistently meet regulatory requirements. Anticipate regulatory changes that could be proactively addressed.
Prioritise the key gaps compared to the regulatory requirements based on compliance risk and strategic imperatives. Short-term and long-term goals will vary based on the company’s current stage of the compliance maturity curve.
Ask whether all key processes are adequately staffed? Does management make quality a priority – in words and actions?
Examine systems and root causes
Assess what matters most for the product and customer. How does work currently get done? What are the detailed activities, drivers, and owners? What could be eliminated?
Undertake a critical analysis of the root causes of past problems. What systems have failed and why? Get to the root cause of the problem using proven techniques like ‘the five whys,’ causal factor tree analysis, failure mode and effects analysis, fishbone diagrams, contradiction tables, and design of experiments.
Examine all quality subsystems (quality, facilities and equipment, materials, production, packaging and labelling, and laboratory control), with a focus on vulnerable processes such as change control, validation, and complaint handling; consider the entire product life cycle.
Determine opportunities
Define performance improvement opportunities. How do the current approaches align with industry-leading practices and organisational models?
Are communication and decision making linkages between geographies, business units and functions sufficiently strong?
Assess critical drivers
Identify the key drivers for product development ‘stage-gates’ used to make decisions. What information is needed in order to ‘fail fast’ or maintain funding? What are the logical linkages between product development processes and quality system processes?
Are metrics established that are both meaningful and attainable to drive performance and assess effectiveness? How do key performance indicators compare against industry benchmarks? How should quality data feed into business processes?
How engaged are business leaders and do they convey a consistent philosophy?
Step 2: Solution Design Develop the future-state operating model and optimised quality system. Addressing sustainable compliance requires a comprehensive solution, taking into account the company’s strategic priorities, goals, and objectives and typically encompasses the following steps:
- Establish a multifunctional steering committee chaired by a high-level process leader.
- Facilitate strategic design workshops to get insight and buy-in from key stakeholders.
- Systematically develop proposed solutions using techniques like sequential design of experiments to optimise every step of the process.
- Simplify, and where appropriate, reduce the number of procedures and processes that reflect how work actually gets (or will get) done.
- Drive internal control ownership and accountability. Tie updated processes to individual job responsibilities.
- Take a broad approach: focus on the organisation as a whole and not silos, on global harmonisation and not individual facilities or product lines. Regulators increasingly expect solutions to be applied systemically throughout the organisation.
- At the same time, balance the need for consistent compliance against the temptation to apply a ‘one size fits all’ approach. What works for one geography, division or product area may not be effective or possible for another. If customisation is necessary, develop and apply umbrella corporate procedures, and allow individual units the flexibility to develop compliant procedures within the umbrella. A different yet still compliant approach is better than forcing a single paradigm is not consistently followed.
Step 3: Implementation
Never underestimate the importance of a properly planned and executed implementation plan, especially if the solution is transformative in nature. Key areas of focus for implementation include:
- Change management. Involve key stakeholders during the process to ensure engagement. Communicate throughout the organisation to keep staff informed and in step with the transition.
- Continued engagement and regular communication by senior leadership. Consider broadening participation in key review boards, to keep quality and compliance issues visible to business leaders.
- Delivery and process transformation. Allow for staged transition from the current to future state.
- Judicious use of technology. Provide the tools, knowledge repositories, and management support infrastructure to transition from tribal knowledge to fully integrated quality systems and business processes.
- Evaluate effectiveness. All corrective actions must be evaluated to ensure effectiveness. Consider a design of experiments approach to systemically evaluate the effectiveness of new processes. Expect changes to be needed. Think of a Stage 4 sustainable compliance system as a living organism requiring regular care and feeding to remain healthy.
Conclusion: A proactive approach is best
Quality problems or enforcement actions may drive a company to begin its journey up the compliance maturity curve, but the best time to take action is before such problems surface. Timely and proactive efforts to drive sustainable compliance minimise the risk of quality problems or enforcement action. Importantly, when not distracted fighting fires, leaders have the relative luxury to practice the art of compliance – to think more strategically and design and implement a Stage 4 solution.
Sustainable compliance is the art and science of managing a business with a clear view of the regulatory requirements. It is a fundamental requirement– and one that can profoundly affect the financial health of the enterprise. It deserves as much attention to excellent planning and flawless execution as any other activity. Done well, it provides competitive advantage, growth and financial health for the shareholders; done poorly, it can mean interruption of supply to customers, long-term decline of a firm’s credibility and the ultimate demise of the business enterprise. Understanding compliance as a core business process and integrating it into the way the organization lives and breathes is the way to success – in India, and around the world.
The time is now. Regulators typically take enforcement action against a company when they see quality and compliance lapses that lead the agency to conclude the company is ‘just not getting it.’ But they also take action against entire industries—with additional and more onerous requirements—when they view the industry as a whole as having eroded quality principles, weak systems, and with top leadership giving more attention to the bottom line than to fundamental quality and compliance. In this current era of heightened enforcement, it’s more critical than ever to get it right. Sustainable compliance is not just nirvana for the process gurus, it’s an imperative. And getting it right will firmly position India’s biopharma sector for continued global success.
References:
1. http://www.fda.gov/NewsEvents/Speeches/ucm294978.htm
2. Rhoades, R, Sustaining Compliance: Strategies for Maintaining Drug Quality, FDANews, 2005.