New good distribution practice (GDP) initiative for medicines and vaccines will “facilitate regulatory compliance”

The GDP Universal Compliance Initiative (GDP-UCI) is a pragmatic, industry-led reform program that is aimed at all companies and organisations that are involved in, or affected by, the laws relating to the distribution of medicines and vaccines. It has a prime focus of facilitating and simplifying adherence to the various pharmaceutical GDP regulations and guidelines that are in place around the world with the objective of making regulatory conformance more consistent, efficient, and risk-free.

“As medicines and their supply chains become ever more complex, and with regulatory oversight being increasingly onerous and pervasive, our research is showing that patient safety can only be maintained if the system of regulatory conformance is clarified and simplified.” said GDP-UCI Executive Director Alan Kennedy.

According to Kennedy, GDP-UCI is not an attempt to rewrite the regulations relating to good distribution practice. Instead, its plans include introducing new concepts for:

a) achieving, demonstrating and recording GDP compliance.
b) generating meaningful GDP metrics for comparison, benchmarking and continuous improvement purposes.
c) creating a more harmonised GDP training environment.

“The GPP-UCI is not about campaigning for legislative changes,” says Kennedy. “Instead it is prioritising greater commonality and consistency in the interpretation and alignment of the different GDP regulations and guidelines from an operational perspective. This is where there is too much interpretational divergence and significant behavioural irregularities.”

GDP-UCI is a collective body, one that is neutral, fully independent and open to all organisations, large and small, that are involved in the movement and storage of pharmaceuticals. As a democratically-governed collaborative enterprise it is completely free of vested-interests and is not promoting, protecting or controlled by any particular business factions.

Kennedy calls on the industry to come together: “We invite all pharma companies and their distribution partners to join the GDP-UCI program to work with their peers to address shared GDP issues, drive supply chain efficiencies, improve regulatory compliance and to safeguard patient safety through continuous improvement.”

Information about the GDP-UCI can be obtained from info@gdp-uci.org