Method Validation Packaging Presentation 
ISPE
MAY 9, 2023
However, existing, or new local regulatory requirements still present hurdles and the regulators’ intention to embrace ICH guidelines or to accept alternate risk-based, scientifically supported approaches may be interpreted negatively by global pharmaceutical companies.
ISPE
AUGUST 29, 2022
Such changes can include increasing batch sizes, adding manufacturing facilities, creating new product presentations, and updating analytical methods. This information package is then submitted in electronic PDF format that health authorities must manually “unpack” or deconstruct in order to perform their assessments.
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