Even the FDA acknowledges there is a disconnect regarding a common agreed upon understanding about exactly what GMP compliance means. Aligning standard operating procedures and implementing quality controls company-wide is a daunting task that is made infinitely more difficult when investment in technologies isn't sufficient to support operational imperatives that drive quality and mitigate risk, not to mention compliance. This is why the 482 issuance rate should be considered a highly valuable decision-making metric in which to judge the quality performance of a prospective CMO.
The ever-increasing importance of quality and compliance in the CMO selection processing is well documented. This white paper, first in a series of three, will provide a framework in which to make a solid, objective evaluation of overall operational excellence as it relates to quality when it comes to evaluating prospective contract manufacturing partners.