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Archive for ‘January, 2011’

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....
January 31, 2011 | Posted in Europe, GMP Policy, General/Quality System, The News in Depth | Read More »

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....
January 31, 2011 | Posted in Europe, Facilities/Equipment, GMP Policy, The News in Depth | Read More »

ICH Q11 Process Validation Discussion Will Be at High Level Given Guideline’s Scope

The ICH Q11 Expert Working Group (EWG) is settling on a high level approach to addressing process validation in its drug substance development and manufacturing guideline, reflecting the challenges of encompassing drug and biotech products and the evolving expectations across the three regions....
January 27, 2011 | Posted in API, Biotech Therapeutics, ICH Q11, International, International Harmonization, The News in Depth | Read More »

IPQ’s Monthly Update for December 2010 Now Available

The IPQ Monthly Update for December focuses heavily on the the ongoing efforts around the world to build a more harmonized foundation for regulating drug and biologic quality.
January 26, 2011 | Posted in The News in Depth | Read More »

IPQ Monthly Update — December 2010

Now available, IPQ's Monthly Update covering the important CMC/GMP developments in the US, Europe and internationally during December....
January 26, 2011 | Posted in Current Issue, Issue Archive, Monthly Update | Read More »

ICH Q11 Draft Gelling On Lifecycle/Change Management and Control Strategy Components

The lifecycle management section of the newest working draft of ICH’s Q11 guideline on drug substance development and manufacturing provides allowance for applicants to include change management proposals in their original submissions....
January 24, 2011 | Posted in API, Biotech Therapeutics, ICH Q11, International, International Harmonization, The News in Depth | Read More »

McNeil Recalls Products for Cleaning Concerns Based on “Comprehensive Action Plan” Review

McNeil’s findings under its “Comprehensive Action Plan” (CAP) of cleaning issues at its Fort Washington, PA plant has resulted in another round of over-the-counter (OTC) product recalls....
January 19, 2011 | Posted in GMP Enforcement Activity, OTC, Recalls, The News in Depth, US/Canada | Read More »

Immunogenic Potential of Aggregates Affirmed at Biotech CMC Forum

The clear potential for aggregates of subvisible particles (SVPs) to cause immunogenic responses in both animals and humans was affirmed at the biotech “CMC Strategy Forum” held in Washington, DC, in mid-January.
January 18, 2011 | Posted in Biotech, Biotech Therapeutics, CMC Standards, The News in Depth, US/Canada | Read More »

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....
January 10, 2011 | Posted in API, Asia, Europe, GMP Deviations/Warning Letters, GMP Enforcement Activity, The News in Depth, US/Canada | Read More »

CMC/GMP Procedures and Interpretations Can Pose Challenges For Foreign Firms in ICH Member Japan

While ICH has had a strong harmonizing influence on Japan’s CMC review process, outside pharmaceutical firms continue to wrestle with understanding and implementing the interpretations and expectations around timeframes, formatting, level of detail and procedural requirements for licensing products in Japan....
January 10, 2011 | Posted in Asia, International Harmonization, Other ICH, The News in Depth | Read More »
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