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QbD Imperatives Reaffirmed by Industry Expert Berridge at ISPE Conference

Quality by design is a critical tool in navigating the complex manufacturing and supply chain shoals through which pharma is now moving, expert John Berridge reaffirmed at the ISPE Washington Conference in June.

ISPE and PDA Initiatives on ICH Q8-10 Implementation Begin Bearing Fruit

The parallel efforts by ISPE and PDA to provide practical assistance to industry on how to implement the QbD, risk management and quality system principles outlined in ICH Q8-10 are starting to bear substantial fruit....

ICH Position Papers Will Address Pressing Issues in Q8-10 Implementation; EU Experience Helps Shed Light

The ICH Quality Implementation Working Group (IWG) is progressing in its effort to develop a series of six position papers covering issues identified by the industry and health agency participants at the 2010 ICH Q8-10 training sessions as needing further clarification. The IWG is planning to complete the six papers by the end of 2011....

Korea is Pressing Forward on CMC/GMP Harmonization Quest

Korea’s quest to more closely harmonize its CMC and GMP quality regulatory processes with ICH/global norms is creating openings for outside companies and regulators to work with the Korean FDA (KFDA) to resolve remaining differences.

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....

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....

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....
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