The methodologies your firm employs in the creation of pharmaceuticals, medicines and similar products designed for human consumption are most likely unique. Even if you follow relatively common chemical or physical manufacturing procedures, for instance, you still have to make modifications that fit your specific product design standards.
When it comes to marketing your output internationally, however, your specialized techniques may pose a problem. Not only do you have to bring your unique work into alignment with quality control standards, you also have to determine which standards to target. Fortunately, ICH harmonization processes can make it a bit easier to implement an acceptable quality risk management system and remain market ready.
Different markets and administrative regions necessarily implement unique legislation governing how certain products can be manufactured, quality checked and marketed. Although bodies like the European Commission have taken steps to unify many different standards, this process requires time and planning. Some GxP-regulated firms may feel as if they’ve been left in limbo in the interim.
Fortunately, the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) has published a number of widely accepted guidelines designed to help unify cGMP standards. Implementing suggestions found within specific guidelines, like ICH Q9, may lead to more adaptable quality risk management systems and help firms align their strategies with the regulations of specific member nations as these are further modified.
Harmonization vs. Standardization
Remember that harmonization is different from standardization. Although the adoption of widespread or standardized methodologies is a common business practice for firms that want to adhere to regulations, harmonization is largely focused on reducing the need for duplicate testing and research during development stages.
Suppose your firm decides to adopt a manufacturing method known to be accepted as safe in two different nations whose markets you’d like to access. Doing so provides no guarantee that you’ll be exempt from having to perform redundant quality checks. Each country could very well have unique compliance requirements for the same method. Because harmonization is specifically designed for more efficient use of resources, it offers more certainty that you’ll be able to streamline your manufacturing processes and preclude wasteful repetition.
Why Implement ICH Guidelines
ICH guidelines have been partially or fully adopted in numerous countries throughout the European Union and Asia. Although the U.S. Food and Drug Administration only considers these suggestions as guidance, the fact it and the Pharmaceutical Research and Manufacturers of America both hold active roles on the ICH Steering Committee means that most ICH guidelines take North American marketability into account.
Harmonization can be a complex endeavor, but ICH processes offer firms the ability to adapt in a fashion that suits their business models. By allowing you to explore different ways that you might use quality risk management instead of forcing you to adhere to very specific manufacturing procedures or test standards, ICH guidelines make it possible to comply more cost effectively.
GxP-CC consultants possess cumulative decades of experience helping successful pharmaceutical firms harmonize their quality techniques with international standards. Discover how they can assist your organization by contacting them.