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Rx-360 Releases Supply Chain Security Management System White Paper

In mid-April, the supply chain consortium Rx-360 published a “white paper” that describes the concept of a comprehensive supply chain security (SCS) management system.  The goal is to provide a foundation for a maturity model that can drive measurable and sustainable improvement of SCS practices. The paper – created by Rx-360 member company SCS experts – provides industry […]

USP Announces New Pharmaceutical QC Training Center in Africa; IOM Report Details Regulatory Shortfalls in Region

USP is planning to extend its effort to help Africa better assure the quality and integrity of its pharmaceutical supply with a new USP training/laboratory center slated to be located in Ghana....

FDA SOP on Drug Cargo Theft Includes Public Notification Provision

FDA has published an internal SOP covering industry and agency responsibilities when pharmaceutical cargo thefts occur that provides for the agency to make the final decision regarding if and when the public will be notified of the thefts. The new SOP is included in the agency's “Staff Manual Guide.”...

USP Releases New Draft General Chapter on Good Distribution Practices and Supply Chain Integrity

USP has released for comment a new draft general chapter <1083> titled “Good Distribution Practices – Supply Chain Integrity” that will be expand its series of information chapters addressing various aspects of the pharmaceutical supply chain. The formal proposal will be published in March/April issue of Pharmacopeial Forum.  Comments are due by May 31. An advance […]

FDA Expands Efforts on Drug Shortages with Cancer Drug Supply Approval Actions and Event Reporting Guidance

FDA has announced additional steps to increase the supply of critically needed cancer drugs to help prevent current and future drug shortages, including approval of a foreign substitute product and accelerated approval of a new domestic supplier. The agency has also released a guidance clarifying agency expectations for reporting events that could result in shortages of prescription products....

EDQM Launches Harmonized Serialization Program eTACT to Strengthen Europe’s Anticounterfeiting Efforts

On January 26th and 27th, the European Directorate for the Quality of Medicines & Healthcare (EDQM) officially launched its “eTACT” anti-counterfeiting IT-based traceability service with a workshop and live demonstration at its Strasbourg, France headquarters....

A Six-fold Increase in Manufacturing Discontinuance Notices Helps FDA Ease Drug Shortages, Agency Reports at House Hearing

FDA has experienced a six-fold increase in notifications of product discontinuance or other problems that could cause a potential prescription drug supply disruption since an executive order and a follow-up agency letter to manufacturers were issued at the end of October....

Pakistani Supreme Court Orders Creation of National Drug Regulatory Authority

In early February, the Pakistani Supreme Court directed the federal government of Pakistan to establish a “Drug Regulatory Authority” within 10 days, after it was informed that five countries had banned the import of Pakistani medicines after the deaths of over 135 patients in Pakistan as a result of contaminated drugs, according to The News […]

IPEC Announces Launch of EXCiPACT

The International Pharmaceuticals Excipients Council (IPEC) Federation announced in early February the launch of EXCiPACT – its new, voluntary international certification scheme designed and developed to assure cGMP and cGDP standards are being used in the manufacture and supply of pharmaceutical excipients. Over 150 stakeholders representing developers, manufacturers, suppliers, distributors, and users of pharmaceutical excipients, […]

USP and IPEC-Europe Weigh in on GDPs for Excipients

USP and the European branch of the International Pharmaceutical Excipients Council (IPEC-Europe) have both released guidance for pharmaceutical companies on the evaluation and handling of excipient distribution....
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