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IPQ-International Pharmaceutical Quality is a UNIQUE group that is on the scene always whenever the US FDA or DIA or PDA meetings happens as they happen , i.e. their reports lets  you get an INSIDERS PERSPECTIVE direct from the US FDA !

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THIS FREE REPORT COVERS A NUMBER OF TOPICS AS DESCRIBED BELOW:

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.
 
 
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