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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)....

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...

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....

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....

The Monthly Update for November is Now Available – A Special Report on the Crisis in Pharmacy Compounding and its Implications

In this Monthly Update, IPQ departs from its usual format encompassing the CMC and GMP developments in the U.S., Europe, and internationally to provide a special report on the causes of the health crisis that has unfolded from fungal contamination in pharmacy compounded injectables and the far-reaching implications that extend across the U.S. drug regulatory arena....

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....

Glass Integrity Threats for Injectables Probed at Wholesale and Specialty Pharmacy Levels

Pharmaceutical manufacturers are beginning to probe deeper into the glass integrity threats to injectable products occurring downstream at the wholesale and specialty pharmacy levels, beyond their traditional reach....
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