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FDA and EMA Will Launch Collaborative QbD Application Review Pilot

FDA and EMA will be conducting a pilot program for joint review of the quality-by-design component of new drug marketing applications – bringing the once-distant vision of a common review process a significant step closer to reality....

Value of Attribute Risk Ranking in Process Development Recognized by ICH Q11 EWG

The current working draft of ICH Q11 promotes the use of risk ranking of quality attributes as a valuable tool in applying quality-by-design (QbD) principles to biotech drug substance development and manufacturing....

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....

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....

PIC/S Site Master File Guide Updated on Quality Management System Expectations

The Pharmaceutical Inspection Cooperation Scheme (PIC/S) has adopted a rewrite of its site master file (SMF) guide for industry that upgrades the expectations on quality management systems (QMS) – and the quality risk management (QRM) and supply chain components in particular – to keep pace with ICH Q9 and Q10....

Membership & US Entry, GDPs, QRM Guidance and Traditional/Herbal Medicine Inspections Draw PIC/S Attention

FDA’s entry into the Pharmaceutical Inspection Cooperation Scheme (PIC/S) at the beginning of 2011 will be marked by the participation of Commissioner Margaret Hamburg at PIC/S’ upcoming 40th anniversary symposium on “Challenges and Future Perspectives” in Geneva, Switzerland in late May....

WHO Guideline on QRM Taking Shape

The World Health Organization (WHO) asked specific stakeholders in August to comment on a working draft of a detailed guideline it is preparing on the expectations for quality risk management (QRM) in pharmaceutical manufacturing. The guideline will update WHO’s advice to industry and regulatory bodies in the risk assessment area and align it with more recent documents published by other international regulatory authorities....

FDA Could be a PIC/S Member by Year’s End

The evaluation committee for the Pharmaceutical Inspection Cooperation Scheme (PIC/S) is expected to recommend FDA’s acceptance into the 37-member organization at the next PIC/S meeting in Kuala Lumpur, Malaysia in November. Membership accession could follow by year’s end.

ICH Q4B Annex 13 on Powder Density and Annex 14 on Bacterial Endotoxin Testing Out for Comment

FDA has made available for comment the Step 2 drafts of ICH Q4B Annex 13 covering the bulk density and tapped density of powders and Annex 14 on bacterial endotoxin testing. The drafts were cleared for release by the ICH Steering Committee meeting in June....

WHO Proposes New Guideline for Microbiology Labs and Adjustments to Site Master File, Water and HVAC Guides

WHO is expanding its guidance library to focus specifically on GMP expectations for microbiology labs and is adjusting its existing guidelines on drafting site master files, on water used in pharmaceutical manufacturing and on heating, ventilation, and air-conditioning (HVAC) systems....
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