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CPhI Report Indicates a Need for Greater Third Party Certification to Ensure GMP Vigilance
Date:7/26/2013

AMSTERDAM, July 26, 2013 /PRNewswire/ --

- QbD and PAT only being used by a third of the industry currently

- CPhI Pharma Insights: formulation and ingredients report

Report highlights:

  • Particle size reduction a major challenge for 60% industry during formulation
  • Bioavailability still a major formulation obstacle- with two thirds listing it as their most urgent challenge
  • India and China thriving as leading API source
    • However quality is still seen as the top issue with APIs and ingredients for half of the industry
  • Over half of respondents outsource clinical work to CROs
  • There is still a reluctance to use CMOs and CDMOs when developing new chemical entities
  • Academic partnerships are on the rise with nearly 40% working with them

CPhI Worldwide and CPhI Pharma Evolution, part of UBM Live's Pharmaceutical Portfolio, announce the conclusions of its first monthly report into the current status of the formulation and ingredients market- conducted amongst high level executives and experts from across the industry over the last month.

     (Logo: http://photos.prnewswire.com/prnh/20130723/629764-a)

The report echoes concerns the regulatory bodies (FDA, EMA) have raised in regards to the necessity of third party auditors to ensure the safety and quality of API and ingredients facilities. Nearly 95% of the respondents agreed that supplier's certification was an important factor, yet despite this only less than a quarter were actively working with third party auditors to vet suppliers- suggesting a greater vigilance is needed to a problem that the industry is still avoiding.

Of those working with third parties, near
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SOURCE UBM Live
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