Method Validation, Packaging and Presentation

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Method Validation

Packaging

Presentation

CMC Requirements for New Drug Registration in Latin America

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.

Documentation

Documentation Packaging Pharmaceutical Companies Pharmaceutical Companies

Streamlining Postapproval Submissions Using ICH Q12 & SCDM

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.

Documentation

Documentation FDA Communication Packaging

Pharmacy Technician Pulse

CMC Requirements for New Drug Registration in Latin America

Streamlining Postapproval Submissions Using ICH Q12 & SCDM

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