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IPQ Monthly Update — November/December 2015 in Review

With the ICH Q12 initiative operating as a catalyst, the dialogue has been intensifying on what is needed to make quality regulatory processes across the product lifecycle more coherent, efficient, process improvement and product supply friendly, and internationally harmonized. This IPQ Monthly Update departs from the usual format to provide a series of stories exploring the various dimensions of the lifecycle management regulatory challenge and the international effort to better address it....

IPQ Monthly Update, June 2015

In focus are: ● FDA’s CDER on the role of the control strategy in application approval recommendations and the challenges reviewers face in piecing the story together ● the key role a novel excipient played in the development of a new insulin inhalation product and the broader implications of the experience, and ● ICH’s effort to address the pressing questions on API CMC and GMP through Q&As on Q7 and Q11....

ICH’s API Coverage Deepening with a Newly Released Q&A on Q7 and a Q11 Q&A Project on Starting Materials Underway

A newly released Q&A from ICH on its active pharmaceutical ingredient (API) GMP guideline Q7 and another Q&A being prepared on the more recently issued API development and submission guideline Q11 are intended to address issues that have surfaced in implementing the two guidelines and drive more uniform interpretation across industry and regulators worldwide....

FDA CMC Reviewer Recommendations for New Drug Approval Depend on Control Strategy Understanding, CDER is Stressing

CDER is stressing that a clear picture of the control strategy is pivotal for CMC reviewers to make a meaningful application approval recommendation and meet the shrinking timelines under which they are operating....

EDQM/USP Monograph Harmonization

The European Directorate for the Quality of Medicines and Healthcare (EDQM) and the United States Pharmacopeial Convention (USP) have jointly decided to halt the 2008 “Prospective Harmonization Pilot Project” initiated to develop harmonized monographs and reference standards for drug substances still under patent. The joint press release notes that the collaboration “revealed complexities” as USP […]

Implementing the ANSI NSF-IPEC 363 Standard on Excipient GMPs Will Help Ensure Compliance with FDASIA, FMD and EU’s New Excipient Risk Assessment Guideline

Implementation of the ANSI NSF-IPEC 363 standard on GMPs for excipients by pharma and excipient manufacturers will help ensure that they are compliant with the supply chain mandates of the FDA Safety and Innovation Act (FDASIA), the EU Falsified Medicines Directive (FMD), and the newly-completed EU excipient risk assessment guideline....

Fear-based Relationships Antithetical to Progressing Quality Systems, While Measurement is Key, CDER’s Woodcock Stresses at ISPE Metrics Forum

The principle that fear-based relationships are antithetical to progressing quality systems is pivotal as FDA reshapes its quality regulatory approach, CDER Director Janet Woodcock is stressing....

WHO Report on Suspect Medical Products

WHO issued a report in late March on a meeting held in October to discuss “substandard/spurious/falsified/counterfeit medical products.” The report includes recommendations for health authorities on strategies for detecting and dealing with suspect and substandard medicines, as well as the prioritized actions member states are taking to prevent their production and distribution.

USP Draft Chapter on Visual Inspection of Injections

In February, USP published a draft general chapter, <1790>, on Visual Inspection of Injections. This chapter expands on methods and concepts in chapter <790> on Visible Particulates in Injections. USP’s focus on its visual inspection coverage parallels the high number of recalls industry is experiencing due to particulates in sterile products.

EMA Guide on ICH Q3D Implementation for Existing Products

EMA issued an implementation guide for the ICH Q3D guideline on elemental impurities in late February. Europe’s two-page guide focuses on implementation issues for existing products and lists the classes of elemental impurities. [For a detailed look at ICH Q3D implementation see IPQ October 23, 2014.]
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