Biopharmaceutical Manufacturing: The Challenge of Global Regulatory Compliance - Pharmaceutical Technology

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Biopharmaceutical Manufacturing: The Challenge of Global Regulatory Compliance
This article provides an overview of regulatory issues facing companies that seek to market their biopharmaceutical agents globally, including a trend toward harmonization of requirements as well as the differences in rules concerning applications, GMP standards, and communication with reviewers.

Pharmaceutical Technology


Given the differences in requirements and expectations among US, European, and Japanese regulators, companies must take a global approach to regulatory compliance issues. For companies looking to expand globally, success often requires building strong working relationships with manufacturing partners that possesses the right degree of vigilance, communication and focus on quality. Following are three golden rules that generally help to smooth the marketing authorization process.

Never take compliance for granted. Differing interpretations of simple international guidelines can hinder the approval process. Therefore, it's critical for biopharmaceutical companies to either build expertise in global regulatory affairs or partner with a CMO that has a strong audit history with regulators in the US, Europe, and Japan. Working with a regulatory group that has the capacity to monitor multiple global entities enables a company to remain apprised of any regulatory changes that can affect their products.

At a minimum, smaller biotechnology operations should consider a CMO's familiarity with global regulatory issues. 0thorities can minimize the potential for costly production delays. An experienced facility will be able to smoothly implement processes and procedures that satisfy the needs of multiple international agencies.

Communicate regularly. When a regulatory group works collaboratively with the technical experts in a manufacturing operation, required facility or procedure changes are likely to be completed smoothly and effectively. As a consequence, it's important for biopharmaceutical companies to consider communication practices when building their regulatory capacity, either internally or with a CMO. Regulatory groups need to communicate consistently with the entire manufacturing organization, including technical services, quality groups, and laboratory personnel. Everyone involved in the manufacturing operation not only should understand the changes that are being required, but also should grasp the rationale behind them.

Strive for quality. It's possible, when dealing with multiple regulatory groups, to lose sight of the ultimate goal of ensuring patients get the drugs that give them the best opportunity for treatment. Having a tunnel-vision approach toward GMP standards, in which changes are made only for the sake of compliance, places a company at risk for delaying marketing availability of a product that could potentially save lives.

When working with a CMO, biopharmaceutical companies need to consider the manufacturer's overall approach to quality, rather than just its history of GMP compliance. It's important for companies and their CMOs to understand and appreciate the unwritten expectations behind these requirements. By working on the front end of the development process to ensure facilities, procedures, and products are of the highest quality, companies will be much more effective in getting vital drugs to the patients that need them.

Kelly Davis is the senior manager of regulatory affairs at Baxter Pharmaceutical Solutions (Bloomington, IN), tel. 812.333.0887, fax 812.332.3079,


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