It is human nature to want to be acknowledged for excellent work that would be considered a “benchmark” for others. Such a benchmark is the regulation of the pharmaceutical markets in the US and the European Union, which have shaped manufacturer work processes, staff training and customer expectation.
Benchmarks such as Good Manufacturing Practice, Good Clinical Practice and International Conference on Harmonization are sending the industry clear signals to comply and embrace the standards and site evaluations for common expectations and control of risks. Many companies are embracing these standards, which, when applied to any facility throughout the world, enable local and foreign players to compete on a common platform. They minimize “guess-work” in what should go on in a facility and enable easy entry of certified professionals into the work process.
A manufacturer from the US could build a GMP-approved facility in Vietnam if the environment and workforce are geared toward fulfilling the requirements. Apart from language and cultural differences, this facility in Vietnam could operate no differently from those in regulated markets.
Even if an Asian facility has no immediate plans to enter the regulated market, it is important to consider embracing these benchmarks. At the International Society for Pharmaceutical Engineering (ISPE) conference held in conjunction with Interphex Asia in Singapore in June, there was much emphasis on benchmarking against standards available.
Likened to academic credentials, these standards give the industry a common platform to understand the level of competency, consistency and growth of a facility. This sets the facility apart in terms of competition, branding, quality and ultimately, profits and patient benefits.
