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NATURAL ENGLAND’S PRELIMINARY VIEWS ON THE PROPOSED TERMS ...
NATURAL ENGLAND’S PRELIMINARY VIEWS ON THE PROPOSED TERMS OF SETTLEMENT Introduction 1. Natural England is grateful to have been granted Rule 6 status in this inquiry.
Determining Criticality Process Parameters and Quality ...
As the pharmaceutical industry tries to embrace the methodologies of quality by design (QbD) provided by the FDA’s process validation (PV) guidance (1) and International Conference on Harmonization (ICH) Q8 Q9 Q10 (2 4), many companies are challenged by the evolving concept of criticality as applied to quality attributes and process parameters.

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