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

pondents, are a result of new drug targets becoming more complex and suffering from solubility issues and poor release profiles. Over two thirds of the pharmaceutical sector suggested 'bioavailability' and 'stability' were pressing challenges for the industry today, with 'dissolution' and 'release' profile also being sources of major concerns for over half the industry.

Solid dosage forms of tablets and capsules still represent 70% of the market with particle size reduction (60%) and tableting and compression (20%) seen as the most difficult to control operations. One solution to this problem could be an increased use of cross-functional teams, with 21% actively hiring and 35% planning to hire more material scientists.

"Material science is a good addition to the diverse range of expertise required for good QbD" notes Carlin. Already we are seeing PAT and QbD are being used more in formulation projects with 35% saying they are using both and a further 36% planning to use them in the near future.  

Yet despite these encouraging signs Ciurczak is critical of the industries hesitance "so 65% of the respondents are waiting to see if QbD really works… when the concepts have already been proven to work in every other industry in the world, from cake mixers to cars". However, Carlin has a more optimistic outlook, especially since the FDAs Office of Generic Drugs is encouraging the adoption of QbD. "The ANDA checklist in being updated to include elements of QbD and as such ANDAs will not be accepted for filing without these elements".

The report concludes that overall the pharmaceutical API and ingredients market is becoming more global and competitive and as regulations change the overall business environment and drug manufacturers will have to adopt. "Companies in the EU and the US have to work with their suppliers to emphasize the value of quality. Quality can no l
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