Why Industry Wants ICH to Harmonize Process Validation Guidance

Executive Summary After a proposal for harmonized process validation guidance didn't make the cut at ICH, PhRMA and US FDA proponents are making the case to a broader audience. Current ICH guidance is unclear, and regional guidance is conflicting, they told the ISPE annual meeting.

Executive Summary

After a proposal for harmonized process validation guidance didn't make the cut at ICH, PhRMA and US FDA proponents are making the case to a broader audience. Current ICH guidance is unclear, and regional guidance is conflicting, they told the ISPE annual meeting.

boexes marked with green check marks
Source: pink.pharmamedtechbi.com