The focus on good distribution practices (GDPs) during regulatory inspections has increased dramatically recently, and the global regulatory community is working on a variety of fronts to refine GDP guidance, standards, regulations and the legislative framework to support them.
The extension of GMP principles from the plant floor to the product distribution chain, and the quality systems needed to support that extension, were explored at PDA’s annual Pharmaceutical Cold Chain Management Conference in Bethesda, Maryland in early March.
At the conference, Abbott Distribution Compliance QA Director David Ulrich provided an in-depth analysis of how the GDP component of GMP regulation and practice is emerging into prominence around the world and the form it is taking in regulations and inspection practice.
Reflecting a significant research effort by the supply chain expert and his Abbott colleagues, Ulrich’s analysis of the progress and divergences in GDP expectations around the world provides a roadmap for the international pharmaceutical community on where its harmonization efforts need to be directed.
[Ulrich’s analysis of the evolving GDP landscape, along with the links he provided to 37 current GDP guidances and regulations from key standard-setting organizations and countries around the world, are provided for subscribers here. The full story can be purchased for $195 by contacting Peter Blachly (Peter@ipq.org). For subscription information click here.]