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CDER Officials Shed Light on Forces Impacting Generic Injectable GMP Compliance and Drug Shortages

FDA’s current engagement with the GMP compliance problems in the generic injectable arena illustrates the tightrope the agency is walking in trying to protect patients against substandard, high-risk products, while at the same time trying to assure that they have access to the critical medicines they need...

Revamped EudraGMP Database May Make GMP Noncompliance Statements Public

In the revamp of its EudraGMP database, the European Medicines Agency (EMA) is considering making GMP noncompliance statements publicly available....

Sponsor/CMO Communication Gaps Will Have Negative Inspection Fallout, FDA Field Investigator Cautions

The lack of communication between sponsors and contract manufacturing organizations (CMOs) – particularly those located abroad – can make the FDA inspection process a difficult one and can jeopardize the compliance position of the CMO involved as well as the approval of the sponsor’s application, agency investigators are warning....

Supply Chains and Customer Service Need Prompt Shoring Up, Veteran Pharma Exec Warns

A veteran pharma executive is sounding a warning call to industry that its current approach to supply chains, outsourcing and customer service needs to be overhauled quickly to address the disruptions causing drug shortages, advance operational excellence, and restore its reputation....

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....

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....
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