ISPE and PDA Initiatives on ICH Q8-10 Implementation Begin Bearing Fruit

The parallel efforts by ISPE and PDA to provide practical assistance to industry on how to implement the QbD, risk management and quality system principles outlined in ICH Q8-10 are starting to bear substantial fruit.

Teams from the two associations are focusing on providing implementation advice and guidance through complimentary and cooperative efforts:  ISPE through its Product Quality Lifecycle Implementation (PQLI) initiative, and PDA with its Paradigm Change in Manufacturing Operations (PCMO) project.

Key players in the five-year-old PQLI effort and the two-year-old PCMO project have met to compare the two initiatives, which were determined to be “different, complementary, and not in competition,” Roche external relations official Stephan Ronninger, who co-chairs PCMO, reported at the PDA Annual Meeting in San Antonio, Texas in April.

“With this in mind,” Ronninger emphasized, “we are determined to utilize the expertise of the two organizations to find practical approaches for the changing pharmaceutical environment according to the new paradigm laid down in ICH Q8–11.”

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