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IPQ Monthly Update, January/February 2015

During January and February, IPQ explored several impactful initiatives that are underway in different areas of the pharmaceutical manufacturing and control arena to create standards and databases that will make both industry and regulators more effective and allow them to communicate better.  These include the efforts of: ● the industry-driven Allotrope Foundation to create lab data standards and the “lab of the future”● FDA in cooperation with industry to continue to implement the 2013 Drug Supply Chain Security Act ● regulators, industry and academia to upgrade pharmaceutical excipient databases, and ● Asian regulators, in line with those in the US and Europe, to address a new generation of regulatory challenges....

New FDA Biotech Inspection Program Will Mine Ten Years of Industry Data to Enhance Targeting and Execution; Field Refining Risk Ranking Process Across Pharma Spectrum

The Center for Drug Evaluation and Research (CDER) is working to update its biotech inspection compliance program to make better use of the process, product, and compliance information it has collected from the industry in the decade since the previous version went into effect and better target its inspection efforts....

Amgen “Analytics of the Future” Initiative Develops MS-based “Multi-Attribute Methodology” to Streamline Biotech Development and QC Testing

Amgen is among the major biotech companies working hard on empowering, while at the same time streamlining, their analytical toolbox at the development and quality control testing levels as the next frontier of quality by design....

Warning Letters Go To Anti-venom and Allergenic Extract BLA Holders

In mid-April, FDA issued warning letters to Instituto Bioclon’s Mexico City anti-venom facility and Greer Laboratories allergenic extract plant in North Carolina. Both biologics facilities were cited for deficient environmental monitoring and failure to conduct investigations.

FDA Finalizes Guidance on Interpreting Sameness of MAbs Under Orphan Drug Regs

In late April, FDA released a guideline on how to interpret “sameness” in the molecular structure of MAb products, antibody conjugates, fusion protein products, and bio-specific antibodies. The guideline was released as a draft in 1999 in response to the related language used in the 1992 orphan drug regulations. The final version remains similar in […]

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....

IPQ Monthly Update, February 2014

In focus are the nexus of problems facing industry and regulators in the global CMC arena. The stories explore: ● the post-approval change constrictions in Japan and how they compare and interface with those globally ● the discussions among a panel of global regulators on expediting reviews, and the implications for the CMC review process ● the impact that the global regulatory maze is having on vaccine suppliers, and ● the challenges the biotech industry faces in making even minor, low-risk changes post-approval, and what needs to be done to address them....

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....

Australia to Adopt EMA Biosimilar MAb Guideline

Australia’s Therapeutic Goods Administration (TGA) announced in mid-February that it is carrying out public consultations on its adoption of the EMA 2012 guideline for biosimilar Mabs.

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....
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