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IPEC Continues to Urge Family Approach in Dialogue with FDA on Improving Inactive Ingredient Database

IPEC-Americas and the Generic Pharmaceutical Association (GPhA) are continuing their advocacy of FDA incorporating a family approach in the toxicology assessment of excipients as they work with the agency on further improving the inactive ingredient database (IID) to support better drug development and more efficient FDA reviews.

IPQ Monthly Update, June 2015

In focus are: ● FDA’s CDER on the role of the control strategy in application approval recommendations and the challenges reviewers face in piecing the story together ● the key role a novel excipient played in the development of a new insulin inhalation product and the broader implications of the experience, and ● ICH’s effort to address the pressing questions on API CMC and GMP through Q&As on Q7 and Q11....

ICH’s API Coverage Deepening with a Newly Released Q&A on Q7 and a Q11 Q&A Project on Starting Materials Underway

A newly released Q&A from ICH on its active pharmaceutical ingredient (API) GMP guideline Q7 and another Q&A being prepared on the more recently issued API development and submission guideline Q11 are intended to address issues that have surfaced in implementing the two guidelines and drive more uniform interpretation across industry and regulators worldwide....

Novel Excipient Enables Successful MannKind Inhaled Insulin Formulation; Formulation/Device Inhalation Technology Offers Platform Potential

The development, testing, and use of a novel excipient as part of its formulation enabled MannKind to develop a viable inhaled insulin product after other firms’ insulin inhalation projects had not been successful....

Implementing the ANSI NSF-IPEC 363 Standard on Excipient GMPs Will Help Ensure Compliance with FDASIA, FMD and EU’s New Excipient Risk Assessment Guideline

Implementation of the ANSI NSF-IPEC 363 standard on GMPs for excipients by pharma and excipient manufacturers will help ensure that they are compliant with the supply chain mandates of the FDA Safety and Innovation Act (FDASIA), the EU Falsified Medicines Directive (FMD), and the newly-completed EU excipient risk assessment guideline....

IPQ Monthly Update, March 2015

During March, IPQ focused on the dialogue that has been intensifying at public forums on the daunting manufacturing and control challenges regulators and industry face in guiding the expanding array of cell and gene therapy (CGT) products now under development to commercialization. The five stories in the Monthly Update for March explore the CMC issues the new therapies pose from the European, US and Asian perspectives and where the emerging approaches are converging and diverging. Two of the stories delve further into the especially challenging but critical task of developing potency assays for the advanced therapies, and another spotlights Novartis’ advancing efforts to adapt biotech manufacturing and control technology and systems to make CGT commercialization a reality....

FDA Urges Improving Characterization, Manufacturing Control, and Potency Assay Design for Cell and Gene Therapies

FDA is advising companies developing cell and gene therapy (CGT) products to focus on improving the characterization of products, control of the manufacturing process, and design of the related potency assays....

Novartis Exploring Boundaries of Biotech Manufacturing and Control to Make Cell and Gene Therapy Commercialization a Reality

Novartis is among the major global pharmaceutical companies that are taking a hard look at how the advancements in biotech manufacturing and control technology and systems can be adapted to help make cell and gene therapy (CGT) commercialization a reality....

Potency Assay Challenges and Pathways for Cell and Gene Therapies Explored by Industry/Regulator Expert Panel

Putting in place a QC-friendly potency assay to support commercialization of cell and gene therapy (CGT) products will require an iterative process that needs to be thought out early in development with regulator input, experts involved are advising....

EU Excipient GMPs Guideline

The European Commission (EC) released a final risk assessment guideline on GMPs for excipients in late March. The guideline points to ICH Q9 for basic principles and goes on to emphasize the need for focus on impurities risks as well as excipient traceability.
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