As part of a maturing industry, pharmaceutical companies are under significant pressure to both innovate and successfully manage increasingly complex operations, more stringent regulatory requirements and frequent consolidations. Many are rethinking their quality management systems (QMS), recognizing the imperatives to enhance agility and improve responsiveness to market needs without increasing quality-related costs.
Creating a lean and agile QMS will be a key source of competitive advantage for these companies. Lean and agile systems have three characteristics:
- The ability to capture customer feedback and regulatory changes, build them into operations and launch new products rapidly.
- A streamlined structure that enables both compliance and operational efficiency, even when faced with increased business complexity.
- The flexibility to incorporate different modalities easily.
While the benefits are clear, a misalignment between the QMS and a company’s operational requirements can have downsides and drive costs. For example, a major U.S. automotive company with a strong quality reputation saw its JD Power IQS ranking fall by more than 15 places after introducing a new entertainment system in its vehicles. The system was complex to operate and frequently malfunctioned. The company responded with a multiyear effort that fundamentally changed how it thought about quality. In pharma, a similar misalignment can result in major quality or compliance issues that lead to hundreds of millions of dollars in remediation costs.
INDUSTRY TRENDS DEMAND A NEW APPROACH
Recent pharma industry trends have significant implications for QMS.
- Technology advances have increased the diversity of products and processes. Products may have more elements (for example, the drug itself, software and a device), while traditional product lines (small and large molecules) have matured and new processes are increasingly more complex.
- Mergers and acquisitions are bringing more and new modalities under the same corporate roof. It is fairly commonplace for companies to face the challenges of integrating QMS from multiple businesses.
- Regulators are using technology to gain access to data and tools that enable more frequent and more in-depth audits with an end-to-end scope. This increased scrutiny demands more extensive sharing of information and a greater emphasis on its integrity. At the same time, advanced analytics are greatly enhancing the ability of regulators and industry players to process this information and derive new insights.
Creating a lean and agile QMS to respond to those trends is not easy:
- Understanding end-to-end processes is challenging in a larger and geographically dispersed organization.
- Legacy QMS have become unnecessarily bulky over time and misaligned with business processes, due to incremental changes in response to quality incidents or audit observations. A pharma site has, on average, 100 to 500 change controls per year.
- Digital technologies and sophisticated data mining have changed the nature of products and innovation in the industry. Companies are increasingly moving toward providing end-to-end solutions comprising products and services.
- The widespread adoption of cloud-based solutions creates new challenges in redefining the paradigm applied to control changes and new-version releases without impeding innovation.
HOW TO DESIGN/IMPLEMENT A LEAN, AGILE QMS
Companies must take a set of steps to implement each element of a lean and agile QMS.
1. Capturing feedback and applying new insights in operations and development. Recent research shows that pharma companies lag behind other industries in capturing customer feedback and incorporating it into future designs. Many companies struggle with the implementation of regulators’ guidelines, resulting in multiple citations over the past few years.
Capturing voice of the customer. Customer feedback is no longer restricted to formal channels, such as product quality complaints and service reports. Capturing information from other avenues is increasingly a formal part of the QMS across industries, though pharma is lagging in this. For instance, consumer companies routinely track and respond to product issues on social media even before a formal complaint is raised. Digital tools can process large amounts of social media data to identify emerging quality issues early. These other avenues are also increasingly monitored by regulators and could trigger increased scrutiny.
Applying lessons across network operations. To avoid a repetition of issues, CAPA and governance systems are critical for enabling an organization to rapidly share lessons learned across the network. One company adopted a systematic process to evaluate the relevance of each audit observation to all sites, regardless of whether the observation involved central or site SOPs. The resulting “CAPA implementation matrix” not only reduced risk but also helped in harmonizing processes across sites.
Integrating and harmonizing QMS with development and operations. A company can facilitate speed to market by harmonizing the reviews (for example, through the use of similar metrics and formal forums in which R&D and operations participate) and using similar procedures during later stages of product development. For example, automotive manufacturers have developed shared modules and platforms across different car models to significantly accelerate the development process.
Leveraging the power of advanced analytics. Advanced analytics is enhancing companies’ ability to understand critical process parameters and material attributes during the commercial phase, resulting in demonstrated reductions in batch failures and deviations. It is equally important for companies to feed these insights back to the early development phase.