ISPE

MAY 9, 2023

In an era when the world is accelerating the development of drugs and targeted medicines using innovative technologies, pharmaceutical companies still face registration hurdles for well-characterized molecules because of redundant or additional local regulatory requirements.

Documentation 52

Documentation Packaging Pharmaceutical Companies Pharmaceutical Companies 52

ISPE

MARCH 7, 2023

A pharmaceutical quality system (PQS) is a management system used to direct and control a pharmaceutical company with regard to quality. Guideline on the Requirements to the Chemical and Pharmaceutical Quality Documentation Concerning Investigational Medicinal Products in Clinical Trials.” Published June 2008.

Packaging 52

Packaging Pharmaceutical Companies Pharmaceutical Companies Hospitals 52

ISPE

SEPTEMBER 10, 2023

In the dynamic global environment, the approval times for postapproval changes can be expected to change over time and may well differ between pharmaceutical companies based on different practices and approaches. You may unsubscribe from these ISPE communications at any time. The proposals are consistent with WHO GRP.

Documentation 98

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