Denise Queffelec
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For the biopharmaceutical industry, product quality and regulatory compliance are fundamentals of business operations and profitability.
In recent years, the industry has become increasingly global. Factors contributing to this globalization include dispersed
physical manufacturing locations, the reliance on outside partners such as contract manufacturing organizations (CMOs), and
the use of multiple active pharmaceutical ingredient (API) suppliers. As the biopharmaceutical manufacturing industry becomes
increasingly global, it faces new quality and compliance challenges.
Many biopharmaceutical companies maintain decentralized, global networks of virtually independent plants with the following:
varying operational and management processes; diverse monitoring and reporting systems; dissimilar equipment or infrastructure;
and multiple local or regional suppliers, contractors, and vendors. However, these companies recognize that, just as their
sales and distribution programs have evolved to meet global opportunities, their quality assurance and regulatory compliance
programs must change.
With ultimate responsibility for assuring the quality and compliance of their products, sponsoring companies must manage a
complex web of assets in an ever-changing regulatory framework. Biopharmaceutical companies are confronted with a growing
list of requirements imposed by organizations such as the European Medicines Agency (EMEA), and the US Food and Drug Administration
(FDA). The US, the European Union, and Japan have an ongoing goal of creating a harmonized regulatory compliance standard,
and the International Conference on Harmonization (ICH) has produced its Q8, Q9, and Q10 guidelines to address quality assurance
and risk management issues. Meanwhile, in the US, two FDA programs—Pharmaceutical cGMPs (current good manufacturing practices)
for the 21st Century, and the Pharmaceutical Quality Assessment Pilot—both of which focus on risk-based analysis, remain works
in progress. The FDA is also revising its cGMP regulations, and it intends to publish the revisions this year.
Some biopharmaceutical companies have already turned away from the traditional methodology of assigning quality and compliance
responsibilities to individual facilities or partners, because this approach often produces inconsistent results. These companies
have embraced a new, enterprise-wide strategy for quality assurance and regulatory compliance. This strategy helps achieve
quality and compliance goals and creates a competitive advantage.
BEST PRACTICES FOR INTEGRATED QUALITY AND COMPLIANCE
The Return on Investment (ROI) of Best Practices
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Companies pioneering enterprise-wide quality and compliance initiatives maintain a series of best practices anchored by centralized
quality-management controls. Returns on investment arise not only from product quality and regulatory compliance, but also
from optimized resources and profitability. Company experiences, combined with the observations and knowledge of industry
experts, provide a blueprint for implementing best practices in achieving a global GMP compliance program based on quality.
Key elements of that blueprint include: consistent messaging and common nomenclature, certifications of employees and subcontractors,
enterprise-wide training, centralized documentation and distribution, vendor certification, integrated systems management,
and quality systems inspection approach.
