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FDA Begins Secure Supply Chain Pilot

FDA has begun its Secure Supply Chain Pilot Program, which will permit 13 participating companies to import up to five products into the U.S. with an expedited clearance. Announced last August, the pilot is intended to allow the agency to focus its surveillance on shipments that are at higher-risk of adulteration or counterfeiting (IPQ September […]

Rx-360 Expanding Presence in China

Rx-360 is introducing a number of initiatives in China. According to Rx-360 Asia Work Group co-leader, Janice Berman, quality assurance VP at Takeda Pharmaceuticals USA, the objective is to set up work groups to help drive activities that have been going on in the US for several years, such as shared resources for supplier audits, […]

IPQ Monthly Update, October, 2013

The Monthly Update for October includes three stories on FDA's draft guidance on quality agreements with CMOs, more on the FDASIA supply chain implementation efforts, as well as in-depth coverage of ICH’s release of its Step 2 draft of Q3D on elemental impurities. An update on CBER’s compliance initiatives is also provided....

Vetting of ICH Q3D Pre-Step 2 Impacts Final Draft; LVP and E&L Issues Could Warrant Further Public Comment

Large volume parenterals (LVPs) and extractables and leachables (E&Ls) from container closure systems were two issues on which the ICH Q3D Expert Working Group (EWG) requested input from stakeholders during the Step 2 drafting process without getting much feedback, and may warrant attention during the draft’s public comment phase that runs through December, EWG members are advising....

IPEC and a Broader Coalition of Industry Associations Identify ICH Q3D Implementation Challenges and What is Needed to Meet Them

The International Pharmaceutical Excipients Council (IPEC) and the Coalition for Rational Implementation of the USP Elemental Impurities Requirements, of which IPEC is a member, have been taking a hard look at where the key challenges lie in implementing the elemental impurity standards in the new Step 2b draft of ICH Q3D and what tools they can provide to assist the pharmaceutical regulatory community in addressing them....

Industry Weighs in on FDASIA Title VII Importation Provisions; Participants Sought for Secure Supply Chain Pilot

Confirming a manufacturer’s state of compliance in advance of its product entering the US, and establishing a risk-based tiered system with correspondingly different documentation requirements for each tier, are among the suggestions the pharma industry is making to FDA regarding the implementation of the importation provisions in Title VII of the FDA Safety and Innovation Act (FDASIA)....

IPQ Monthly Update, July/August 2013

The IPQ Monthly Update for July/August 2013 is now available....

NSF-IPEC 363 GMP Standard Will Provide Risk-Based Approach for Auditing and Certifying Excipient Manufacturers

NSF International is working with the International Pharmaceutical Excipients Council (IPEC) and FDA to turn the IPEC excipient GMPs into a risk-based, certifiable standard with global applicability by the end of 2013, as recognition of the importance of excipient control continues to grow....

Revision of EU Annex 16 Clarifies QP Responsibilities in the Face of an Increasingly Complex Supply Chain

A clear distinction between the release of a batch and its certification by the Qualified Person (QP), directions for what responsibilities the QP can share and how, and a template for use by a QP to sign off on a subset of manufacturing steps are among the significant changes EMA has incorporated into a revision of its Annex 16, which was released for public comment in early July....

FMD Implementation in Europe Drives Better API Sourcing Knowledge and Interagency Communications

Implementation of Europe’s Falsified Medicines Directive (FMD) has shed important light on what the active pharmaceutical ingredient (API) part of the global pharmaceutical supply chain actually looks like and has led to enhanced communication between the countries that participate in it....
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