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Continuous Manufacturing does not Present Regulatory Hurdles, FDA Experts Say

The regulatory definitions of “batch” and “lot” do not present hurdles for implementing continuous manufacturing, FDA is stressing in highlighting the potential the new processing approaches offer to advance the objectives of its 21st Century quality initiative....

Quality System Adjustments Needed for Continuous Manufacturing

The quality system adjustments needed to accommodate continuous manufacturing are getting attention at regulator/industry forums where the dialogue on how to drive forward the new processing technologies is underway....

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....

EU Documentation GMPs Updated to Reflect Electronic Records and Quality Systems Mindset

The European Union has updated its GMP expectations for documentation to reflect the realities of electronic record keeping and the evolving quality systems-based regulatory framework....

EU GMP Annex 11 Revision Adds Risk Assessment, Contractor and Validation Coverage for Computer Systems

The revision of Annex 11 to the EU GMPs on computerized systems, released in mid-January, calls for the application of risk management principles through the system lifecycle and clarifies the expectations for third party service providers and validation....

Analytical Method Transfer In Focus in EU Effort to Revise GMP Chapter 6 on Quality Control

The transfer of analytical laboratory methods within and between companies is being targeted by the European Medicines Agency (EMA) to receive more attention in a revision to its EU GMP Guide Chapter 6 on quality control....

Active Ingredient and Starting Material Supply Chains in Focus in Draft Revision to EU GMP Guide Chapter 5

The European Commission (EC) has released for comment a revision to EU GMP Guide Chapter 5 on production that provides new requirements for control of active ingredient and starting material supply chains, including reports documenting periodic supplier audits for inspector review....

New Draft Broadens EU GMP Guide Chapter 7 from Contracting to All Outsourced Activities

The European Commission has released for comment a revision to Chapter 7 of the EU GMP Guide on outsourced activities that expands the scope of coverage and incorporates quality system and risk management principles from ICH Q9&10....

House Committee Surveying FDA’s Puerto Rico District 2000-2010 Oversight Activities

The House Committee on Oversight and Government Reform is requesting that FDA provide a wide variety of documents pertaining to the last decade of compliance oversight by its Puerto Rico field office....

FDA-Wide Effort Underway to Clarify and Harmonize CAPA Definitions in Line with New GHTF Guide

FDA Center for Devices and Radiological Health (CDRH) GMP expert Kimberly Trautman is spearheading an effort to clean up and harmonize the definitions around corrective and preventive action (CAPA) across the agency in line with a Global Harmonization Task Force (GHTF) guideline on CAPA that is nearing release....
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