Industry Prepares For Emerging ICH Q14 Quality-By-Design Approach To Analytical Methods

 
• By Joanne S. Eglovitch
  
Generate a summary of this article
Listen to this article
Beta

EU industry group advises drug makers on how to prepare for enhanced quality-by-design approaches to analytical methods that the International Conference on Harmonization plans to propose early next year. ICH recently shared its concept, which involves revising its Q2(R2) guideline and adding a Q14 guideline, and its business plan for establishing the guidance.  

Portable Raman Spectrometer - Image

More than a decade after the pharmaceutical industry and leading regulatory authorities adopted the quality-by-design approach to pharmaceutical development, it looks like QbD concepts are finally going to extend to analytical methods. ICH is planning to propose guidance in early 2020 that it hopes to finalize a year later. Meanwhile, a European industry group has provided additional guidance to help industry prepare for the emerging lifecycle management approach to analytical procedures.

A paper from the European Federation of Pharmaceutical Industries and Associations explains how manufacturers can implement some of the enhanced...

Pink Sheet Podcast

Learn what's happening at the US FDA. On the go.

Derrick Gingery and the team bring you a weekly "Drug Fix".

SpotifyApple PodcastsWebsite

More from Manufacturing

Califf: Not Wise To Create Problems Related to Chinese Pharma Supply Chain Dependence

 
• By Sarah Karlin-Smith

The US FDA Commissioner pushed for a rebalancing of the US’s pharmaceutical supply chains while also stressing that there is a role for US-China commerce that would be risky to compromise.

UK MHRA First-Half New Drug Approvals Show Overwhelming Use Of EU Reliance Procedures

 
• By Ian Schofield

The UK regulator approved 16 medicines containing a new active substance in the first half of this year, while the European Commission issued marketing authorizations for 20 NAS-containing drugs.

HTA Regulation: EU Publishes Guidance On Validity Of Clinical Studies For Joint Clinical Assessments

 
• By Francesca Bruce

Joint clinical assessment reports must be descriptive rather than reach definitive conclusions, and must not interfere with national decision making processes, according to new EU guidance.

Draft US FDA Innovative Manufacturing Strategy Takes On Global Inconsistency

 
• By Bridget Silverman

The agency’s plan for advanced manufacturing seeks more harmonization, while also seeking to codify internal practices with guidance and training.

More from Compliance

HTA Regulation: EU Publishes Guidance On Validity Of Clinical Studies For Joint Clinical Assessments

 
• By Francesca Bruce

Joint clinical assessment reports must be descriptive rather than reach definitive conclusions, and must not interfere with national decision making processes, according to new EU guidance.

India And Pakistan Boost Transparency In Industry-Doctor Interactions

 
• By Vibha Sharma

Developments in India and Pakistan are designed to standardize how drug companies disclose their expenses associated with health care professionals.

Draft US FDA Innovative Manufacturing Strategy Takes On Global Inconsistency

 
• By Bridget Silverman

The agency’s plan for advanced manufacturing seeks more harmonization, while also seeking to codify internal practices with guidance and training.