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

ly 31% of respondents said they are working with USP's Verified Ingredients Program; with 18% using EXCIPACT; and 10% using either IPEC or APIC.

The lack of action on the part of industry is due to poor communication both internally and with suppliers according to Girish Malhotra, CPhI expert industry panel member. "People who are visiting supplier sites must be familiar with manufacturing and analytical practices and both suppliers and buyers must agree on what certifications are needed. No shortcuts!"

Fellow panel members echoed these thoughts with Emil Ciurczak, commenting "there are inconsistencies because we work in silos", whilst Brian Carlin reiterated these sentiments adding "the combination of concerns over quality, supply and a lack of understanding suggest the need to move to more pharmaceutically aligned suppliers".

In fact, half of the respondents felt quality was a top issue, with 41% adding that supply was a major issue with API and ingredients. However, problems with quality may not be entirely down to a lack of certification of ingredients according to Carlin, "If inconsistency of quality is due to unknown excipient attributes, beyond the certification of analysis, part of the problem may be inadequate feedback to suppliers".

Outsourcing is widely recognised as a major trend across the industry, yet despite this only just over a third of the industry is currently partnering with CMOs and CDMOs, which perhaps reflects a reluctance to outsource new chemical entity development for fear of potential IP infringement. However, over half the respondents are already working with CROs during clinical trials and nearly 40% are currently working with academic groups during development.

The leading formulation issues, according to the survey res
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SOURCE UBM Live
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