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SFDA Releases Revised “Good Supply Practices” Guideline

China’s State Food and Drug Administration (SFDA) has released a revision of its good distribution practices guideline – which SFDA terms “good supply practices” (GSPs) – that will take effect at the beginning of June. Firms will have three years to come into full compliance.  After that time, non-compliant firms will no longer be able […]

Iowa, Massachusetts, California and Virginia Intensify Compounding Pharmacy Crackdown

The crackdown on pharmacy compounding in the wake of the fungal meningitis crisis continues to intensify as states such as Iowa, Massachusetts, California and Virginia pursue a combination of tougher licensing requirements, more frequent inspections, aggressive enforcement, and a better understanding of the operations of compounders selling in their states....

QP Review of More Complex Supply Chains and Applications, EU Member State Differences, Among Issues Facing EMA in Annex 16 Revision

EMA’s GMP/GDP Inspectors Working Group (IWG) is wrestling with how to build into EU GMP Annex 16 the assurance that the Qualified Person (QP) understands the complexities of a globalized supply chain in certifying that a batch complies with GMP/GDP requirements and the new mandates of the Falsified Medicines Directive (FMD)....

EMA GMP Chapter Draft Revisions Focus on Current Compliance Focal Points from Shared Facilities to Defect Investigations

The European Medicines Agency (EMA) has released draft revisions of four of its GMP chapters, intended to communicate its expectations regarding current compliance focal points including supply chain oversight, shared facilities, starting materials, lab method transfers, and investigating and reporting quality defects....

Alleged Use of “Gutter Oil” to Produce Antibiotic Intermediate in China Probed

The government of Central China’s Jiaozuo city sent a team in early September to a subsidiary of Joincare Pharmaceutical Group to investigate allegations that the firm is manufacturing an antibiotic intermediate using reprocessed cooking oil, called “gutter oil,” China Daily reports. China’s State Food and Drug Administration (SFDA) announced that it would investigate the truth […]

FDASIA Title VII Empowers FDA in Supply Chain Arena; Congress Adds Other Tools to Help on Drug Shortages and Theft

Title VII of the Food and Drug Administration Safety and Innovation Act (FDASIA) gives FDA additional tools it has been seeking to better confront the challenges of regulating a global supply chain....

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....

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.”...

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....

GDPs, APIs, and non-European GMPs on PIC/S Radar Screen as Membership Expands

The Pharmaceutical Inspection Cooperation Scheme (PIC/S) is taking a close look at the developing global guidance on good distribution practice (GDP), including the new guidance that has been emerging from Europe and WHO, in assessing its expansion into the GDP arena. Also on PIC/S’ radar screen are active pharmaceutical ingredients (APIs) and the organization’s relationship to the GMPs of its expanding membership – in particular, those of FDA....
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