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 CMO 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 CMO and customer.
The pharmaceutical industry has undergone a sea of change in recent years as manufacturers have adapted to the end of the era of large-volume production of mass-market blockbuster drugs. With firms now focusing in on subpopulations of patients, there is a need for lean, adaptable facilities that can switch quickly between multiple products in multiple formats. Modular facilities can meet this need. While not a panacea, for the right project characteristics, ‘Modularity in Design’ can deliver significant and quantifiable long-term value.
A common problem statement in the pharmaceutical industry is low oral bioavailability of drug candidates with poor aqueous solubility. The literature suggests that a significant majority of new drug candidates are in the Biopharmaceutics Classification System (BCS) class II and IV space, which includes compounds that are dissolution rate, solubility or permeability limited to absorption, or all three. As portfolios across the industry are increasingly focused on these compounds, the need for enabling technologies continues to grow.