IPQ Monthly Update — April 2011 in Review

The GMP regulatory umbrella is expanding around the globe to encompass a more defined body of good distribution practices (GDPs) and increased enforcement of supply chain controls. The Monthly Update for April includes six stories on key developments in the industry/regulator effort to better control the global supply chain.

At the center of the IPQ coverage is a comprehensive survey, performed by Abbott Labs under the direction of its supply chain expert David Ulrich, of the prominent regulatory/inspection initiatives to strengthen the GDP component of GMPs across the globe – from the US and Europe to other regions such as South America and Asia, and encompassing government, industry and international standards setting organizations.

A second story focuses more specifically on the regulatory challenges pharma companies are facing regarding the control/stability of products during shipping and the solutions being advanced.  Included are case studies of Merck’s experience in Latin America and a review of PDA’s current projects to further the quality of temperature-sensitive products during distribution.

One of the PDA projects warranting separate coverage is the formulation of a “stability budget” approach for assuring the quality of pharmaceuticals through the distribution process.  The Pharmaceutical Cold Chain Interest Group (PCCIG) spearheading the project hopes to elevate it all the way to the ICH Q1 level.

Another significant association-driven initiative intended to help address the challenges and hazards of the current pharmaceutical supply chain is the IPAC-RS effort to spread GMP consciousness across the intricate web of inhalation component suppliers. The April issue provides an update of the consortium’s effort to drive forward the implementation of its GMP guidelines for OINDP component manufacturing and supply – including its work with UK’s Pharmaceutical Quality Group (PQG) to extend the reach of its global PS-9000 certification standard into the inhalation arena.

In the other two supply chain-related stories, IPQ delves into recent developments in the serialization component of GDP: ● the challenges pharmaceutical companies face in meeting the evolving serialization requirements that regulatory agencies are imposing, and ● how GS1’s serial number approach is gaining traction as a globally harmonized solution to the track and trace problems posed by the complex global supply chain.

The IPQ Monthly for April also includes an update on how the ICH Quality Implementation Working Group is progressing in its effort to develop a series of six position papers covering issues identified by the industry and regulatory agency participants at the 2010 ICH Q8-10 training sessions as needing further clarification.

In March, IPQ focused on the CMC and GMP regulatory challenges for the expanding array of combination products and technologies.  The April issue explores another component in the CP regulatory picture that is gaining increasing prominence – human factors/usability.  The story focuses on the industry/regulator dialogue on developing a viable approach to HF/usability analysis for combination products in the US and Europe.

The Monthly for April continues IPQ’s effort to keep its readers at the forefront of the dialogue on the regulatory challenges posed by the new generation of biologicals and how regulators are approaching these challenges. This Update calls attention to the increased understanding of the significance of the higher order structure of proteins and FDA’s current thinking about how that understanding should be incorporated into its review process.

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