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The News in Depth

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....

CBER Releases Updated Compliance Program Guide on Inspection of Biological Drug Products

The Center for Biologics Evaluation and Research (CBER) released in June a revised version of its Compliance Program Guidance (CPG) 7345.848, “Inspection of Biological Drug Products,” which combines and replaces previous versions of CPGs covering related biological products and provides inspectional guidance to investigators for conducting biennial or for-cause inspections across the biologics spectrum....

FDA Seeing Wide Variation in Drug Application Manufacturing Submissions, Causing Approval Delays

Manufacturing information that is inaccurate, incomplete, inconsistent, or in the wrong section in new and abbreviated new drug applications (NDAs/ANDAs) as well as facilities not being ready for an inspection continue to be problem areas causing delays in application approvals, Center for Drug Evaluation and Research (CDER) officials are reporting....

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....

Genzyme Allston Plant Resumes Normal Operations Although Shortages Continue

In a June 29 update, Genzyme clarified its current production status and the impact remediation efforts are having on its ability to release product and supply the market....

New FDA Draft Guidance Reduces Reporting Burden for CMC Postapproval Changes

A new draft guidance from FDA specifies 40 types of low-risk manufacturing changes that will now quality for annual report filing and represents a significant step in the agency’s effort to reduce the number of supplements that have to funnel through the Center for Drug Evaluation and Research (CDER) clearance process....

USP Upgrading Bioassay Coverage; FDA Weighs In on Bioassays at AAPS’ National Biotech Meeting

The US Pharmacopeia (USP) is upgrading its coverage related to bioassays to keep pace with the evolving science and technology. In its July/August Pharmacopeial Forum, USP is proposing revisions for public comment to General Chapters <1032>, <1033>, and <1034>, which address the design, validation, and analysis of bioassays respectively....
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