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