ISPE and PDA have performed a detailed analysis of their two key initiatives ‘PQLI’ and ‘PCMO’ in order to ensure coordination and prevent unnecessary duplication. As a result, program leaders have determined that there is no significant overlap between the efforts of each organization. In those cases where overlap has been identified, agreement was reached to realign the scope and to work together to avoid any duplication of effort.
In summary, both ISPE and PDA have agreed that the PQLI and PCMO deliverables are:
With this in mind, we are determined to utilize the expertise of two organizations to find practical approaches for the changing pharmaceutical environment according to the new paradigm laid down in ICH Q8 (Q11), Q9 and Q10.