Subscribe
  
IPQ Inside the global regulatory dialogue

Your Search Results

The Most-Read IPQ Stories of 2015

As a retrospective on 2015, IPQ is providing the two stories that generated the largest readership during the year (available in full to non-subscribers as well as subscribers).

The Most-Read IPQ Stories of 2014

As a retrospective on 2014, IPQ is providing the two stories that generated the largest readership during the year (available in full to non-subscribers as well as subscribers).  

The Most-Read IPQ Stories of 2013

As a retrospective on the past year, IPQ is providing a compilation of the four stories that generated the largest readership. [Available in full to non-subscribers as well as subscribers.]

欧州FMD実施、優れたAPI調達知識と省庁間通信推進

CASSS CMC Strategy Forum Japan の参加者の皆様方に IPQ のレポートの価値をさらにご理解 いただくために、 最近の月例アップデートの中から1つ記事を抜粋し、日本語に翻訳して紹介させていただきます。また、どのような 範囲の話題を月例アップデートに取り上げているのかをご理解いただけるように、日本語に翻訳した第1面の目次 も一緒に送信しました。この記事の日本語PDF版については次のウェブサイトをご覧ください:

IPQ Top Ten Stories for 2012

To kick off the New Year, IPQ is providing a compilation of the ten stories that generated the largest readership in 2012.

IPQ Monthly Update — November 2012

Due to the critical nature of the compounding crisis and to help facilitate the dialogue around how such tragedies can be prevented in the future, IPQ is making this report publicly available beyond its subscription/licensee base....

IPQ Special Report — May 2010

THE QUALITY REGULATORY INITIATIVES UNDERWAY AS THE NEW DECADE BEGINS show the strong imprint of ICH Q8-10 at both the agency and international levels. From CMC application review to GMP inspections, from development to post-market manufacturing, from the ingredient supply chain through product distribution, the quality-by-design, risk management and quality system principles built into the […]

IPQ Special Report — July/August 2009

THE PROCESS VALIDATION PARADIGM IS CHANGING and the implications for the way manufacturers control their process and regulators inspect them is being assessed. An FDA draft guideline has made clear that validation is a journey that extends across the process lifecycle from design to qualification to continued verification. Regulators will be expecting a more coherent and transparent approach to assuring process and product performance and managing the relevant knowledge.

IPQ Special Report — May/June 2009

ANALYSIS OF FDA AND EU GMP ENFORCEMENT ACTIVITY shows inadequate investigation of manufacturing and product nonconformances to be the most pressing concern on both sides of the Atlantic. FDA warning letters and injunctions are frequently linking GMP problems with the manufacturing of products that do not have the required new drug approval or do not […]

IPQ Special Report — March/April 2009

DRUG MANUFACTURERS ARE REASSESSING HOW THEY MANAGE REGULATORY INSPECTIONS as they shift focus onto the challenge of conveying the strength of their quality systems to find and address problems and risks. The diversity of inspectors and regulatory agencies that manufacturers routinely face also is prompting them to clarify and refine their approach to managing inspections. […]
Pages: 1 2 Next

Subscription Benefits

SUBSCRIBE TODAY and get 24/7 access to the IPQ family of publications:

.
● “In the News” — breaking stories on our website

● “News Alerts” — sent via email

● “Monthly Updates” — 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 HERE  for the IPQ Monthly Update – July/August 2020 in Review


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

.

©2020 IPQ Publications