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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....

FDA’s Focus On Lab Practices Abroad Continues in Four Recent API Warning Letters

Laboratory practices – a recurrent area of concern in FDA inspections abroad – again took center stage in a series of warning letters issued by the Center for Drug Evaluation and Research (CDER) compliance office to four foreign active pharmaceutical ingredient (API) manufacturers in December....

More Guidance on Transport Storage Conditions Targeted by EMA

The European Medicines Agency (EMA) is proposing to expand its guidance on transport storage conditions to better address the challenges of an increasingly complex ingredient supply and product distribution chain....

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....

Contamination Control in Aseptic Processing Draws FDA Warning in U.K.

FDA inspection observations in late July of evidence of mold contamination in a Class 100 aseptic suite and inadequate controls in place to prevent it led to a warning letter to Wrexham, U.K.-based CP Pharmaceuticals at the end of October....

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....

Laboratory Control Issues Prominent in Recent Warning Letters to Four Overseas Firms

Laboratory control problems are prominent in a bolus of FDA drug GMP warning letters recently issued to companies in Asia and Europe....

Temperature and Storage Conditions Top the List of Major/Critical Deficiencies in MHRA GDP Inspections

Temperature and storage conditions were the most common Good Distribution Practice (GDP) deficiencies ranked “major” and “critical” by the UK Medicines and Healthcare products Regulatory Agency (MHRA) during inspections conducted from January to June of 2010....
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