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ICH Q3D Could Provide Model for More Inclusive ICH Process; Focus Continues on Q3D Implementation Challenges, Including Risk Assessments

The development and implementation of the ICH Q3D guideline on elemental impurities could provide a model for a more inclusive ICH process....

Pharmacopeial Modernization and Harmonization Efforts Spurred by Global Supply Chain Regulatory Needs; China’s Pharmacopeia Among Asian Participants

The risks to product quality in an increasingly globalized supply chain – a prime driver of the CMC and GMP agendas of regulatory agencies – are also pushing pharmacopeias around the world to speed up their efforts to harmonize and modernize the compendial standards that support these regulatory processes....

EDQM Publishes Annual Report for 2013

In mid-June, EDQM published its 2013 Annual Report. The report explains the function of the EDQM, its relationship to the European Pharmacopeia, and the major changes that took place within the directorate during 2013. Some highlights include the adoption of 30 new monographs, the addition of 2 new general chapters, and the modernization of quality […]

EDQM Signs Confidentiality Agreement with Taiwan FDA

In late May, EDQM signed a confidentiality agreement with the Taiwan FDA. The confidentiality agreement concerns the “certification of suitability to the monographs of the European Pharmacopoeia,” and includes communications about the quality assessment of APIs and excipients used in manufacturing as well as about GMP inspections of manufacturing sites.

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....

ICH Vets Another Pre-Step 2 Q3D Draft to Strengthen Consensus on Heavy Metal Standards

In mid-December, the ICH Q3D Expert Working Group (EWG) sent out a second, pre-Step 2 draft of its elemental impurities guideline to draw further input from constituent organizations on the challenging, broadly impactful issues it encompasses, with the target of achieving a draft that meets the Step 2 ICH consensus criteria by mid-2013....

The Monthly Update for November is Now Available – A Special Report on the Crisis in Pharmacy Compounding and its Implications

In this Monthly Update, IPQ departs from its usual format encompassing the CMC and GMP developments in the U.S., Europe, and internationally to provide a special report on the causes of the health crisis that has unfolded from fungal contamination in pharmacy compounded injectables and the far-reaching implications that extend across the U.S. drug regulatory arena....

USP and IPEC-Europe Weigh in on GDPs for Excipients

USP and the European branch of the International Pharmaceutical Excipients Council (IPEC-Europe) have both released guidance for pharmaceutical companies on the evaluation and handling of excipient distribution....

USP Publishes First Medicines Compendium Standards

In late November, USP published the first ten standards to be included in its Medicines Compendium (MC).  The new standards cover medicines used as anti-HIV agents, antivirals, analgesics, oral contraceptives and antiparasitic treatments. The recently authorized standards cover: acyclovir, acyclovir topical cream, amlexanox, chloroquine oral solution, chloroquine phosphate, chloroquine sulfate, etoricoxib, nelfinavir mesylate, ormeloxifene hydrochloride […]
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