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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....

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....

IPEC Significant Change Guide

The IPEC Federation announced the availability of its “Significant Change Guide for Pharmaceutical Excipients” in mid-January. The guide is designed to provide a uniform approach in evaluating how changes to the manufacture and distribution of an excipient will impact a product and whether regulatory authorities or manufacturers should be informed. This is the first guide […]

EMA to Share Generics Assessments

EMA announced in mid-January that it would share its assessments of applications for generic drugs with other regulatory agencies. The first phase of its “International Generic Drug Regulators Pilot,” started in July 2014, involves the EU, Australia, Canada, Chinese Taipei, and Switzerland. Initially ten applications for generics will be shared.

USP and Russia to Develop Quality Standards

In mid-December, USP held discussions with experts from the Russian Federation on collaborating on the development of drug quality standards. A press release from USP discusses how the International Training Program (ITP) is being utilized to create more quality regulatory personnel for Russia’s Federal Service on Surveillance in Healthcare.

IPQ Monthly Update, November 2014

In focus are the structure, function and impact of two components of the new Office of Pharmaceutical Quality that will be on the front line of its industry/agency interactions: ● the Office of Program and Regulatory Operations (OPRO), which will play a pivotal role in CMC reviews, and ● the Office of Surveillance, which will be spearheading the agency’s effort to more coherently assess a company’s quality management. Included on the international front are stories on: ● how the Europe-based association APIC is mapping API requirements in emerging countries and working with them to make their processes more effective and user friendly, and ● IPEC’s efforts to narrow the excipient maker/user communication gap on visible particles....

APIC is Mapping API Requirements in Emerging Countries and Working with Them to Create More Transparent, Efficient, and Harmonized Regulatory Processes

The Europe-based Active Pharmaceutical Ingredients Council (APIC) is mapping out the current API registration requirements in emerging countries, defining best practices, and developing strategies for working with the various authorities on creating more transparent, efficient and harmonized regulatory processes....

IPEC Seeks to Improve Excipient Maker/User Communications on Visible Particles

The International Pharmaceutical Excipients Council of the Americas (IPEC-Americas) is spearheading an effort to strengthen the communication pathway between excipient makers and users about the significance of benign visible particles in excipients....

New Zealand and Australia Drop Plans for Joint Regulatory Agency

A joint statement was released by the health ministers of Australia and New Zealand to announce the end of efforts to establish the Australia New Zealand Theraputics Products Agency (ANZTPA). The decision followed a review of the progress and assessment of the costs to each country. The statement notes that the two countries plan to […]

PDA Post-Approval Change Harmonization Initiative

In mid-September, PDA announced that it was forming a task force to work on harmonizing global post-approval change protocols for typical manufacturing changes and providing a template for post-approval change management. [For a review of a PhARMA proposal for a new approach to CMC submissions approach that would better accommodate postapproval changes see IPQ October […]
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