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Archive for ‘July, 2011’

J&J Board Report Explores Causes of McNeil’s Compliance Breakdowns

A report on an inquiry by a committee of J&J board members into the firm’s recent compliance problems provides insights into how staff reduction, acquisition integration, and communication gaps between operations, company management and the board can contribute to compliance breakdowns in a big pharma organization....
July 27, 2011 | Posted in Consent Decrees, GMP Deviations/Warning Letters, GMP Enforcement Activity, Recalls, The News in Depth, US/Canada | Read More »

New EU Draft Guideline Clarifies, Broadens and Deepens Expectations for GDPs

The EU’s new draft guideline on Good Distribution Practices (GDPs) makes a substantial contribution to the product manufacturer-to-patient component of the global regulatory community’s effort to clarify, broaden and deepen GDP regulatory expectations....
July 26, 2011 | Posted in Europe, General, Shipping & Storage, Supply Chain/GDPs, The News in Depth | Read More »

IPQ’s Monthly Update for June is Now Available

The progress that industry and regulators are making in implementing the ICH Q8-10/QbD-based regulatory paradigm and where further work needs to be done is the focus of a series of four stories included in the IPQ June “Monthly Update.”
July 24, 2011 | Posted in The News in Depth | Read More »

IPQ Monthly Update — June 2011

The Monthly Update covering the key CMC and GMP developments in the US, Europe and internationally during June is now available....
July 24, 2011 | Posted in Current Issue, Issue Archive, Monthly Update | Read More »

ICH “Points to Consider” on Implementing Q8-10 Addresses Control Strategy Development and Filing

ICH’s newly-released “Points to Consider” (PTC) on implementing Q8-10 underscores the need for QbD-based marketing applications to provide a scientific justification for the proposed control strategy, including enough information, clearly enough organized, for regulators to understand how the firm developed it....
July 18, 2011 | Posted in CMC Standards, ICH Q8-10/QbD, International, International Harmonization, QbD, The News in Depth | Read More »

Control Strategy is Nexus for QbD Regulatory Paradigm, US and EU Regulators Affirm

CMC review policy makers in the US and Europe are focusing increasing attention on the control strategy as the nexus for the advancing pharmaceutical quality-by-design regulatory paradigm....
July 18, 2011 | Posted in CMC Standards, ICH Q8-10/QbD, International, International Harmonization, QbD, The News in Depth | Read More »

QbD Imperatives Reaffirmed by Industry Expert Berridge at ISPE Conference

Quality by design is a critical tool in navigating the complex manufacturing and supply chain shoals through which pharma is now moving, expert John Berridge reaffirmed at the ISPE Washington Conference in June.
July 18, 2011 | Posted in ICH Q8-10/QbD, International, International Harmonization, The News in Depth | Read More »

ISPE and PDA Initiatives on ICH Q8-10 Implementation Begin Bearing Fruit

The parallel efforts by ISPE and PDA to provide practical assistance to industry on how to implement the QbD, risk management and quality system principles outlined in ICH Q8-10 are starting to bear substantial fruit....
July 14, 2011 | Posted in ICH Q8-10/QbD, International, International Harmonization, The News in Depth | Read More »

FDA Micro Lab Data Concerns Continue with Warning Letter to Second Indian Firm

A warning letter to Ahmedabad, India-based Cadila Healthcare, issued by FDA’s drug compliance office in late June, is the second in as many months to cite an Indian sterile product manufacturer for recording air sampling plate counts that did not match what agency investigators observed during the inspection....
July 11, 2011 | Posted in Asia, GMP Deviations/Warning Letters, GMP Enforcement Activity, Injectable, The News in Depth | Read More »

EU Moves to Revise its GMP Annex 16 to Clarify QP Role

The EMA’s Inspector’s Working Group (IWG) is working on a concept paper for revising EU Annex 16 with the aim of better defining and harmonizing the role of the QP across the EU member states....
July 7, 2011 | Posted in Authorities, Europe, GMP Policy, Production/Validation, The News in Depth | Read More »
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