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IPQ Monthly Update – February / March 2016 in Review

IPQ continues its in-depth exploration of the changes FDA is making to its quality regulatory structure, processes and expectations – their impact and global significance. Focal points include: ● a progress report on OPQ’s first year ● the manufacturing innovation taking place in the more nourishing regulatory environment ● other key issues on the current OPQ agenda ● CDER’s new risk-based API review process, and ● reviewer concerns with biotech product excipients. Also covered on the international front are EDQM’s efforts to drive API regulatory harmonization.

EDQM’s International API Convergence Efforts Encompass Generics Regulator Forum IGDRP, Monographs and Inspections

The efforts by the European Directorate for the Quality of Medicines (EDQM) to further API quality regulatory harmonization include its participation in the International Generic Drug Regulators Program (IGDRP), which released in March a common form for submitting drug master files for active substances (ASMF/DMF), a common template for reviewing them, and a lexicon of common […]

FDA is Advising Biotech Product Applicants to More Clearly Justify Their Excipient Usage

FDA’s Office of Pharmaceutical Quality (OPQ) is asking biotech product sponsors to fully explain the process used to select excipients and to provide a risk assessment on potential interactions between the excipients and their proteins.

The Most-Read IPQ Stories of 2015

As a retrospective on 2015 – a year full of impactful developments in the pharmaceutical quality regulatory arena – IPQ is providing a listing of the stories that generated the largest readership. The two stories that led the 2015 list are provided in full. While the two have an FDA orientation, both have important implications for the international efforts to advance quality regulation and better connect its review and inspection components. The stories that follow in our “most read” listing (see p. 2) speak clearly to the depth and breadth of IPQ’s coverage and its mission of supporting the global dialogue.

Dissolution Testing and the BCS Among Quality Topics High on the OPQ/PQRI Agenda

Making dissolution testing and the Biopharmaceutics Classification System (BCS) it supports more meaningful is high on the agenda of the Office of Pharmaceutical Quality (OPQ) as it works with the Product Quality Research Institute (PQRI) to advance the quality regulatory process.

Pharma Manufacturers are Making Progress Down the Six Sigma Pathway

Pharmaceutical manufacturers are starting to find the process-capability holy grail of six sigma – a goal that many thought not long ago was unattainable for pharma.

Continuous Manufacturing/QbD Relationship Explored by Industry and Regulators at FDA/PQRI Conference

The impact of continuous manufacturing (CM) on the ability of pharma to fully implement quality by design (QbD) and realize its benefits is becoming clear as the technology moves into full operation.

Emerging Technology Approvals Among FDA Office of Pharmaceutical Quality’s First-Year Achievements

The positive impact that FDA’s Office of Pharmaceutical Quality (OPQ) has had during its first year in operation includes the extra support the agency has been able to provide for emerging technologies, as witnessed by the agency’s first approvals of drug products using continuous manufacturing and 3D printing.

FDA’s OPQ Adapts ANDA Risk-Ranking Model for Drug Substance Reviews

FDA’s Office of Pharmaceutical Quality (OPQ) has adapted the risk-ranking model developed for abbreviated new drug application (ANDA) reviews to its review of drug substances, with the goal of improving communications internally and with industry regarding API risks and deficiencies, and in turn, the overall efficiency and predictability of the process.

IPQ Monthly Update – January 2016 in Review

FDA’s vision of a quality regulatory process that would be more efficient, science-based, review/inspection coherent, and process improvement and product supply friendly took more concrete shape during 2015. The January Monthly Update explores what the progress looks like across CDER’s Offices of Generic Drugs and Pharmaceutical Quality. Also in focus is the complex web of challenges that a global drug distribution system presents in trying to identify and trace products and what regulators and industry are trying to do to deal with it.
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Front page Nov.Dec. 2015Click here for the November/December 2015 Monthly Update


IPQ’s Mission:

IPQ is dedicated to helping advance the dialogue on evolving and harmonizing the regulation of pharmaceutical and biologic quality and manufacturing.

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Subscribe today and get 24/7 access to the IPQ family of publications: In the News — breaking stories on our website; Weekly News Alert — sent via email; Monthly Update — the key CMC and GMP developments in the US, Europe and internationally; Special Reports — in-depth analysis of specific, emerging issues of regulator/industry concern; and Documents and Archives — live links to all the documents referenced in our stories and full access to IPQ’s valuable archive library.

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