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India Reduces Stability Data Requirements

In mid-October, CDSCO established that it would reduce the requirement for long-term stability testing from twelve months to six months. The accelerated stability test requirement will remaining at six months.

USP Proposes New Standards for Organic Impurities

Appearing in the May-June 2014 issue of the Pharmacopoeial Forum (PF) were a draft chapter proposal and a draft chapter revision updating USP’s coverage of organic impurities. The revision of general chapter <1086> on drug substance/product impurities and the proposal for the addition of a chapter <476> on drug substance/product organic impurities, which will align […]

CDER Releases Q&A on Stability Testing for ANDAs

In mid-May, CDER’s generics office issued a Q&A “to more effectively address the public comments” related to the September 2012 draft guidance on “ANDAs: Stability Testing of Drug Substances and Products” (see IPQ Sept. 10, 2012). The Q&A is organized into a general section and specific sections addressing drug master files, drug product manufacturing and […]

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The Monthly Update for October includes three stories on FDA's draft guidance on quality agreements with CMOs, more on the FDASIA supply chain implementation efforts, as well as in-depth coverage of ICH’s release of its Step 2 draft of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....

IPEC/Coalition on USP <233> and PDE Calculator for Elemental Impurities

Coalition for Rational Implementation of the USP Elemental Impurities Requirements has released comments to USP concerning the sample preparation methods listed in General Chapter. The Coalition commented that the chapter should concern only biorelevant analysis rather than focusing on the total content of impurities. A PDE calculator was also released by the Coalition to assist […]

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....

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....

FDA’s Draft ANDA Stability Guidance Applies ICH Expectations to Generics

The Office of Generic Drugs (OGD) has released a new draft guidance indicating that Abbreviated New Drug Applications (ANDAs) and the Drug Master Files (DMFs) that support them will be expected to follow the stability recommendations provided in the ICH Q1A-E stability guidelines....

New FDA ANDA Stability Guidance Will Embody ICH Standards; GPhA Supportive With Some Adjustments

The Office of Generic Drugs will be issuing a new draft stability guideline that will more formally align the expectations for Abbreviated New Drug Applications (ANDAs) and Drug Master Files (DMFs) with ICH and a QbD-oriented regulatory paradigm....

EDQM’s Efforts to Clarify Starting Material Expectations Include Internal Policy Guide; SM Dialogue Continues

The European Directorate for the Quality of Medicines and Healthcare (EDQM) has been working hard to better define its policies around starting materials in view of their impact on the regulation of active pharmaceutical ingredients (APIs)....
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