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USP Draft Chapter on Visual Inspection of Injections

In February, USP published a draft general chapter, <1790>, on Visual Inspection of Injections. This chapter expands on methods and concepts in chapter <790> on Visible Particulates in Injections. USP’s focus on its visual inspection coverage parallels the high number of recalls industry is experiencing due to particulates in sterile products.

Hospira Heparin Recall

A recall by Hospira of heparin in mid-September is the latest in a string of particulate-related recalls of Hospira injectables. Other of the firms products recalled for particulates over the past year include lidocaine, bupivacaine, and propofol.

USP Official Chapter <787> and <1787> for Particulate Matter

USP issued a new official general chapter <787> in early August on particulate matter for sensitive protein formulations. Chapter <787> includes a testing framework for issues regarding the immunological effects of sub-10µm particles. Informational chapter <1787> accompanies the general chapter to provide guidance on sub-visible particles in the 2 to 100µm range and will become official […]

PDA Releases Revised Technical Report 13 on Environmental Monitoring

A revised version of the PDA Technical Report 13 was released in late May. This technical report serves as a resource on controlled environmental test methods for sterile product manufacturing. The revision updates the previous 2001 version, reflecting the changes to regulatory guidelines, international standards, and scientific advances in environmental monitoring. The report is available […]

FDA Data Integrity Findings Continue at Indian Firms, Highlighting Challenges in Changing a Facility’s Quality Culture

FDA investigators are continuing to uncover serious data integrity issues at facilities in India, including repeat citations – highlighting the challenges regulators face in getting companies to make changes in their quality culture....

International Panel of Regulators Spotlights Current Biotech CMC Regulatory Problems and Convergence Pathways

The limitations, constraints and disconnects in the current CMC regulatory processes around the world are emerging into high relief as the biopharmaceutical community wrestles with how to get new medicines that fill critical healthcare gaps more rapidly to patients and how to facilitate manufacturing adjustments that better assure the quality of marketed products....

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....

Biotherapeutics Developers Are Wrestling with Challenges of Connecting Quality Attributes to Immunogenicity

The developers of biotherapeutics are intensifying their efforts to understand the complex relationships between the structure of their molecules and immunogenicity and to expand the predictive power of their CMC toolbox. However, there is also a growing recognition of the long-term nature of the project and the difficulties in validating the quality analytical tools against the less than solid ground of immunogenicity assessments in the clinic....

Industry is Exploring How to Empower Pharmacovigilance Programs to Find GMP Root Causes

Building a system capable of finding quality problems through a firm’s pharmacovigilance program must begin early in development, one of the leading experts in the field, Lilly Global Patient Safety Senior Director John Ayres, is advising industry....

Vetting of ICH Q3D Pre-Step 2 Impacts Final Draft; LVP and E&L Issues Could Warrant Further Public Comment

Large volume parenterals (LVPs) and extractables and leachables (E&Ls) from container closure systems were two issues on which the ICH Q3D Expert Working Group (EWG) requested input from stakeholders during the Step 2 drafting process without getting much feedback, and may warrant attention during the draft’s public comment phase that runs through December, EWG members are advising....
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