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IPQ Monthly Update, January 2014

In focus in IPQ’s Update for January are: ● the efforts by biotech product manufacturers to get a better grip on the quality/immunogenicity relationship ● the current FDA drug compliance office priorities – including the implementation of DQSA, FDASIA and CDER reorganizing to advance quality oversight, and ● the top problem areas FDA reviewers are seeing in analytical method filings and their advice on how to avoid them....

Post-Approval Change Regulatory Burden Draws Heat at Japan Biotech CMC Strategy Forum

Industry associations have been meeting with Japanese regulators to highlight the problems they are experiencing in Japan’s process for regulating post-approval manufacturing changes, including a lack of flexibility around biotech product changes that results in most requiring prior approval as well as meetings with the agency to resolve unclear expectations....

The Most-Read IPQ Stories of 2013

As a retrospective on the past year, IPQ is providing a compilation of the four stories that generated the largest readership. [Available in full to non-subscribers as well as subscribers.] The attention the stories drew is not surprising as they delve into four key current focal points in the CMC/GMP regulatory arena: ● data integrity ● contract relationships ● quality metrics, and ● process validation.

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The Monthly Update for October includes three stories on FDA's draft guidance on quality agreements with CMOs, more on the FDASIA supply chain implementation efforts, as well as in-depth coverage of ICH’s release of its Step 2 draft of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

IPQ Monthly Update, July/August 2013

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

FDA Data Integrity Concerns Continue in India as Three More Firms Draw GMP Warning Letters

Three warning letters recently issued on findings at facilities in India indicate FDA’s continued focus on data integrity as a central concern of its international inspection program – and in the Indian arena, in particular....

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....

Burden of Pre-Inspection Submission Requests from Agencies Outside the US and Europe is Growing

Pharma industry experts are expressing concern with a new trend of emerging country agencies requesting significant amounts of manufacturing and facility information prior to performing GMP inspections and are proposing that the international community work toward a more clearly-defined, manageable and harmonized approach....

IPQ Monthly Update, June 2013

FDA’s center for drugs recognizes that deeper changes to the quality regulatory paradigm are needed to realize the vision embodied in the 21st Century initiative a decade ago of a pharmaceutical industry set on a pathway of continuous process improvement throughout the product lifecycle....

IPQ Monthly Update — May, 2013

The IPQ "Monthly Update" for May is now available. Read this story for a concise summary of its contents.
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CLICK HERE  for the IPQ Monthly Update – July 2021 in Review


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