In the broadest sense, the purpose of a quality agreement is to clearly define, establish and delineate the responsibilities of the respective QA departments from the service provider and its customer, in order to clearly communicate the responsibilities of each party, with the ultimate goal of assuring patient safety and regulatory compliance. An added benefit of implementing a clear, concise quality agreement is that it creates a more effective and efficient working relationship between service provider and customer.
In 2014, the contract manufacturing market for solid dosage forms is anticipated to be $19.6B, representing 58% of the total CMO market value of $33.7B. While the market value percentage for solid dose has been drifting downward — likely related to the shift towards biologics, which are more expensive to develop and manufacture — the propensity to outsource oral solid dosage forms continues to grow modestly.
Several recent trends in capsule filling offer pharmaceutical manufacturers the possibility of doing more than just filling capsules. New developments in capsule filling technology can improve efficiencies as well as yields. The latest machines have on-board diagnostics and the ability to perform corrective actions during processing that directly address QbD principles, while increasing production efficiency.
This article presents guided wave radar level measurement as an acceptable, less expensive alternate to load cell systems. By David Ladoski and Dan Klees
Maintaining sterile process conditions is a vital but daunting task for manufacturers. Separation processes like filtration and chromatography place considerable demands on sterile systems and must be done properly to ensure the purity of media.
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