Clinical development plan quality assurance

It is interesting to note how PV and quality assurance (QA) have expanded to include not only technology transfer but also some of the development activity namely, PV associated with clinical supplies production. Another factor that has influenced the need to validate the manufacturing process is the involvement of the contractor, whose site has become the primary or alternate location for the sponsor to manufacture the clinical or commercial product. With this expansion it was inevitable that organizations would formalize the master validation plan as a building block of TQM. Furthermore, it is appropriate to include the validation plan for each clinical production process in the master validation plan. 

Establish procedures for segregating sick people from exposed but asymptomatic people at clinics. Develop quality assurance plan. 

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