How to Shift from Reactive Compliance to Strategic Quality Management - A culture of quality that emphasizes business objectives, risk management, and the informed application of technology can


How to Shift from Reactive Compliance to Strategic Quality Management
A culture of quality that emphasizes business objectives, risk management, and the informed application of technology can improve compliance.

BioPharm International
Volume 22, Issue 7


Virtually all companies can increase compliance levels and improve overall quality management through benchmarking. By helping to identify, adopt, and deploy the best practices of diverse life sciences organizations, as well as best internal practices, benchmarking programs make it possible for companies to develop individualized best manufacturing practices.

One specific process—quality management benchmarking—can help companies analyze the costs and risks associated with reaching best-practice compliance. Quality management benchmarking provides a clear view of inter-departmental connectivity, so it helps QA and executive management implement processes and technologies that support an integrated, strategic approach to quality. Quality benchmarking also can help forge links between those responsible for the financial health of the company and those responsible for the quality of products produced.

Quality management benchmarking seeks to answer two important questions. The first question is: Is the compliance effort harmonized across regulatory standards in the markets for the company's products, such as the US, EU, Japan, and China?

Despite the ultimate stringency of regulation, most drug regulations are subject to interpretation. Yet many companies take the gray ink of regulations as the indelible black ink of dogma. They will therefore develop one set of standard operating procedures (SOPs) for their US sites, another set of SOPs for their European sites, and another for Japan. But it is far more efficient and cost-effective to develop and maintain one overarching set of SOPs that harmonizes requirements across all three markets with a sub-set of SOPs that covers any absolutely clear differences.

The second question is: How do specific compliance practices within departments compare with other departments in the same company; other sites in the same company; the competition; other relevant industries in the global marketplace; and other companies in nonrelated industries but with some similar business processes?

If different departments in the same company—such as R&D, manufacturing, and pharmacovigilance—are handling similar compliance matters differently, then compliance can't be managed effectively. Benchmarking across departments enables the enterprise-wide alignment of these activities. For example, information technology is pervasive in biotech companies. Data should be standardized across departments and computer system validation should be consistent.

Sometimes, different sites dedicated to different therapeutic areas in a company will use different SOPs for compliance. This situation is often encountered following mergers and acquisitions. Here, too, benchmarking across sites can uncover opportunities for consistent and strategic management of compliance.

Benchmarking against other biotech companies is difficult because the cultural, people-driven components of various companies differ widely and are difficult to replicate. Although such benchmarking may not enable emulation, it can provide a window into successful business practices. Biotech, despite a plethora of things that make it different from small-molecule pharmaceuticals and other businesses, is still, after all, a business. And many business practices translate well from industry to industry.

For example, consider biotech as a knowledge-based business. Although the end-product is a biologically-derived compound, the research leading up to the development, data in the clinical trials and subsequent applications, information highly relevant to drug safety, and so on, is ... well, information. Successful businesses "tag" this information with certain actions (such as proactively passing it to a colleague, to R&D, to medical affairs or legal, or even to certain parts of manufacturing). This tagging enables a knowledge lifecycle and actually enhances the knowledge by further enabling a state of proactive collaboration. Information has thus been transformed from a static to a dynamic state and becomes a business asset.

Benchmarking against other relevant global industries, such as small-molecule pharmaceuticals or medical devices, can provide additional insights into best practices in regulated industries. Benchmarking against unrelated industries with similar business processes, like oil and gas or automotive, can provide insight into the management of protracted, expensive R&D, or quality programs.

A quality management benchmarking program must begin with the establishment of metrics that help quantify program success and provide a basis for re-assessment. The same metrics also may help QA executives establish cost-bases or estimates to improve their overall quality program. In the process of establishing these metrics, companies must be able to recognize their most critical compliance issues. Do they trend more in the R&D side as opposed to manufacturing, product delivery, or even within QA itself? Also, how is quality currently measured? The most compliance-focused (reactive) companies, for example, often use GMPs as their primary, and even sole measure of quality. Finally, the development of quality metrics helps companies determine cost-reduction "actuals" before implementing complex information systems.

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