IPQ Inside the global regulatory dialogue

The News in Depth

Culture and Process Capability Continue In Focus as FDA Releases Its Draft Quality Metrics Guidance

FDA is asking for industry input on how quality culture and process capability evaluations can contribute to the “baseline” metrics it has put on the table for review in its draft quality metrics guidance.

Wave 2 of ISPE’s Quality Metrics Pilot Will Explore Metric Relationships and How to Deepen Industry’s Role in Advancing the Regulatory Process

Wave 2 of ISPE’s quality metrics pilot is being designed to enhance the understanding of the relationships between the metrics that emerged into relief during Wave 1 and to provide further support for FDA in developing a more data-driven regulatory process.

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....

FDA CMC Reviewer Recommendations for New Drug Approval Depend on Control Strategy Understanding, CDER is Stressing

CDER is stressing that a clear picture of the control strategy is pivotal for CMC reviewers to make a meaningful application approval recommendation and meet the shrinking timelines under which they are operating....

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....

IPQ Monthly Update, April/May 2015

IPQ’s coverage during April and May was heavily focused on how the GMP/quality system thought processes in the pharmaceutical regulatory arena are advancing, and the April and May issues have been combined to bring the stories under one roof. Included in the April/May Monthly Update are stories covering: ● CDER Director Woodcock on the philosophy behind FDA’s “quality revolution” – why fear is antithetical to its goals and why measurement is key ● a Deming Institute expert on where pharma is in applying Deming’s quality philosophy ● a compliance official on what FDA’s foreign inspection findings indicate about pharma’s current risk modeling overseas ● the impact of the new risk-oriented ANSI NSF-IPEC 363 excipient GMP standard on excipient suppliers and drug manufacturers, and ● Sanofi’s effort to coordinate the lifecycle management of its automation systems to head off manufacturing breakdowns…

Sanofi is Coordinating the Lifecycle Management of its Automation Systems to Head Off Manufacturing Breakdowns

Sanofi is focusing more attention on coordinating the lifecycle management of its automation systems to head off the major threats to the continuity of manufacturing operations that ensue from not having a well thought-out planning process in place....

Pharma May be Missing 80% of the Power of Deming’s Methods, Deming Institute Expert Maintains at PDA/FDA Q10 Workshop

Deming Institute Advisory Board Chairman Kelly Allen maintained at a PDA/FDA Pharmaceutical Quality System (ICH Q10) Workshop on Quality Risk Management that the pharmaceutical industry has, in general, been missing 80% of the power of Deming’s management methods, which involve understanding: ● the organization as a system ● variation ● the theory of knowledge, and ● human psychology....

High Foreign Inspection Failure Rate Indicates Need for Better Pharma Risk Modeling and Supplier Oversight Abroad, FDA Compliance Official Stresses

The current high FDA foreign inspection failure rate points to the need for the pharmaceutical industry to develop better risk models and intensify supplier oversight abroad, a senior official at the Center for Drug Evaluation and Research (CDER) Office of Compliance (OC) is stressing....
Pages: 1 2 3 4 5 6 7 8 9 10 ...45 46 47 Next

Subscriber Login

Subscription Benefits

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
  • Documents and Archives — Live links to all the documents referenced in our stories and full access to IPQ’s valuable archive library






Click to Enlarge

Click to Enlarge

Click here for the June 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.

IPQ takes its readers from:

  • ● the headlines to the forces driving them
  • ● regulations and policies to their underlying intent
  • ● the pieces of the puzzle to their interconnection
  • ● requirements to implementation pathways
  • ● random data to critical trends
  • ● the sidelines to helping shape the outcome
  • ● compliance problems to proactive quality tools
  • ● information to intelligence


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.

©2015 IPQ Publications