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ICH Q11 Guideline Structure and Content Taking Shape

The structure and content of ICH Q11 on drug substance development and manufacturing is taking shape as the Expert Working Group (EWG) resolves the challenging issues around the guideline’s breadth and depth and its relationship to the other guidelines in the ICH quality family....

Regulatory Transparency vs. Industry Flexibility at Issue for Starting Materials in ICH Q11

The ICH Q11 Expert Working Group (EWG) has been wrestling with balancing regulatory transparency with industry flexibility in defining the starting material as it moves forward in drafting the guideline on drug substance development and manufacturing....

Regulatory Import of Non-critical Parameters Among Issues Under Debate at ICH Q8-10 Workshop

The expectations for non-critical parameters in communicating with regulators on process design, control and change management drew significant attention at the ICH Quality Implementation Working Group (IWG) training workshop in Tallinn, Estonia in early June....

Generics Industry Outreach Urged at Q8-10 Implementation Workshop in Estonia

The importance of pulling the generics industry more directly into the QbD/ICH Q8-10 implementation process was stressed by key regulatory and industry officials during the concluding session at the ICH Quality Implementation Working Group (IWG) workshop in Tallinn, Estonia in early June. The workshop was sponsored by the associations PDA and ISPE....

Senior Management Involvement is Critical for ICH Q8-10 Implementation Success, Regulators Affirm

Regulators from all three ICH regions participating in a Q8-10 training workshop in Estonia in early June stressed the need for pharma company senior management support of quality system principles – pointing to the improved quality, compliance, communication and relationships with regulators that result from this commitment....

ICH Q8-10 IWG Making Adjustments Based on Estonia Workshop and Follow-up ICH Meeting

The ICH Q8-10 Implementation Working Group (IWG) has concluded, based on its industry/regulator workshop in Tallinn, Estonia in early June and the IWG’s internal meeting the following week, that refinement of the training model used in the workshop, additional Q&As, and further evaluation of the other ICH quality guidelines for inclusion of Q8-10 principles are needed....

Pfizer Finds QbD a “Large Value Proposition,” VP Migliaccio Tells DIA Annual Meeting

Pfizer’s assessment of its data on the impact of implementing quality by design indicates that QbD is “a very large value proposition,” Global Manufacturing Network Performance Senior VP Gerald Migliaccio reported at DIA’s Annual Meeting in Washington, D.C. on June 16....

QbD is Changing the Quality Regulatory Landscape in the US and EU

The quality regulatory initiatives underway as the new decade begins show the strong imprint of ICH Q8-10 at both the agency and international levels. The May 2010 issue of International Pharmaceutical Quality (IPQ) provides an in-depth analysis of how quality by design and the new Q8-10 paradigm is transforming the quality regulatory landscape....

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....

Novo Nordisk QbD Initiative Gaining Traction Faster Than Anticipated

Novo Nordisk’s broad-reaching quality-by-design (QbD) initiative for protein development is gaining traction faster than the company had anticipated, fueled by buy-in from top management and the production department....
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