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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....

EMA Process Validation Draft Targets Filing Requirements and Assessor Needs

The European Medicines Agency (EMA) has released a draft process validation (PV) guideline that mirrors FDA’s PV guide in principle, but is aimed more at the content and assessment of marketing authorization applications rather than the execution of validation in a manufacturing facility....

Congressional and FDA Hearings Throw Spotlight on Drug Shortage Problems and Potential Solutions

The increasing number of shortages of medically-necessary pharmaceuticals, and of generic injectable drugs in particular, drew the attention of the US Congress and FDA in separate public hearings held in late September....

EU Moves to Revise its GMP Annex 16 to Clarify QP Role

The EMA’s Inspector’s Working Group (IWG) is working on a concept paper for revising EU Annex 16 with the aim of better defining and harmonizing the role of the QP across the EU member states....

Early Dialogue on Annex 16 Revision Raises Questions About QP/Quality System Relationship

Key issues for industry as the EU moves to revise Annex 16 will include how much responsibility can reasonably be placed on the QP, how those responsibilities dovetail with the quality system and its management, and the definition of the term “personal knowledge” as used in the current version of the annex and its relationship to auditing....

Extensive Vetting of FDA’s Draft Process Validation Guidance Smoothes Its Transition to Final Form

The extensive vetting process on FDA’s draft process validation guidance confirmed to the agency that only a relatively few clarifications were needed to bring the draft into final form....

WHO Updating Sterile Processing Guide to Align with US, EU, and Japan

The World Health Organization (WHO) is updating its Annex 4 “Good Manufacturing Practices for Sterile Pharmaceutical Products,” replacing its 1999 version of that document to align with more recent guidance issued by the three ICH countries....

FDA Touting Benefits of Continuous Manufacturing

One area, in particular, that FDA is focusing on as a significant opportunity for advancing its quality-by-design objectives is continuous manufacturing. CDER officials’ have been highlighting their interest in continuous manufacturing at recent conferences, noting the recent progress that has been made in converting the concept into practice....

IPQ Special Report — May/June 2009

ANALYSIS OF FDA AND EU GMP ENFORCEMENT ACTIVITY shows inadequate investigation of manufacturing and product nonconformances to be the most pressing concern on both sides of the Atlantic. FDA warning letters and injunctions are frequently linking GMP problems with the manufacturing of products that do not have the required new drug approval or do not […]
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