The Regulatory Walls are Falling Down!

For the longest time, pharmaceutical and other life science companies have had to deal with the FDA when selling their product in the US.  If they wanted to sell into other countries, they would have to deal with a new set of regulators.  Manufacturing sites were treated as separate entities, and were inspected by local districts, or regulators from different countries, depending on where a product was shipped. In recent years though, the pharmaceutical industry has been globalizing, opening sites worldwide.  They are using multi-tiered material suppliers where identifying the actual source can prove to be difficult.  While this has been going on for years, the regulators were, and actually still are separate entities, serving their individual country's needs.  However, a change is upon us. 

ICH Q 8 Q 9 and Q 10 have been finalized and are the current thinking at most of the major regulatory agencies including the US FDA.  These agencies are sharing information, co-inspecting sites, and collaborating.  They understand that they cannot all individually inspect and assure the quality of our global supply chain.  There are cases where one agency has inspected a site of a company and discovered issues.  Within days, another country’s regulators show up at another location of the same company, with the other’s inspection report in hand.

ICH Q 10 is the updated standard for GMP quality systems.  While 21 CFR 210 & 211 are still regulation, or law, the previously released “CGMP’s for the 21st Century – A Risk Based Approach” Final Report (April 2004), “Quality Systems Guidance” (September 2006), and the “Q10 Pharmaceutical Quality Systems” (April 2009) provide the evolution of FDA’s current thinking.  Q 10 is truly an international standard, and US FDA embracing it as their standard goes a long way towards a global harmonization of regulatory inspection standards.

ICH Q 10 brings to the forefront management responsibility within a Pharmaceutical Quality System.  This means regulatory authorities hold corporate management ultimately responsible for product quality, no matter the source, or where in the tiers of the supply chain the problem originated.  Inspectors no longer are looking at individual manufacturing sites, but now have help globally in discovering the source. 

It’s a globalized industry, and the regulators are catching up!

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