Subscribe
  
IPQ Inside the global regulatory dialogue

Your Search Results

FDA’s Focus On Lab Practices Abroad Continues in Four Recent API Warning Letters

Laboratory practices – a recurrent area of concern in FDA inspections abroad – again took center stage in a series of warning letters issued by the Center for Drug Evaluation and Research (CDER) compliance office to four foreign active pharmaceutical ingredient (API) manufacturers in December....

Laboratory Control Issues Prominent in Recent Warning Letters to Four Overseas Firms

Laboratory control problems are prominent in a bolus of FDA drug GMP warning letters recently issued to companies in Asia and Europe....

FDA Releases Guideline on Animal Drug Substance CMC Filings in CTD Format

FDA’s Center for Veterinary Medicine (CVM) has released a guideline on how to file drug substance CMC information for new and abbreviated new animal drug applications (NADAs/ANADAs) in the Common Technical Document (CTD) format. The CMC guideline was released as a final version rather than as a draft for comment....

ICH Q11 Guideline Structure and Content Taking Shape

The structure and content of ICH Q11 on drug substance development and manufacturing is taking shape as the Expert Working Group (EWG) resolves the challenging issues around the guideline’s breadth and depth and its relationship to the other guidelines in the ICH quality family....

Regulatory Transparency vs. Industry Flexibility at Issue for Starting Materials in ICH Q11

The ICH Q11 Expert Working Group (EWG) has been wrestling with balancing regulatory transparency with industry flexibility in defining the starting material as it moves forward in drafting the guideline on drug substance development and manufacturing....
Pages: Prev 1 2 3 4

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 2021 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

.

©2021 IPQ Publications