Draft Guidance for Industry on Contract Manufacturing Arrangements for Drugs: Quality Agreements; Availability

PDA commends FDA on writing this guidance which highlights common gaps which have occurred in the past between CMOs and Owners and clearly points out many elements of current best industry practice. PDA suggests that FDA further emphasize in this guidance, the importance of establishing a collaborative relationship between the parties in addition to clearly assigning and defining the appropriate responsibilities. In some instances the guidance appears to be asking that the Quality Agreement include listings of parts of the CMO's quality system. We recommend clarifying that the intent is for the Quality Agreement to assign responsibilities to parties by general categories rather than a restatement of individual GMP elements. PDA also recommends against requiring specific procedures to be included in the Quality Agreement since such an approach might inhibit the effective functioning of either party's quality system with respect to continual improvement.