Definition, Documentation and Method Validation

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Definition

Documentation

Method Validation

What is quality risk management in pharmaceutical?

GMPSOP

MARCH 4, 2023

Additional documents included each month. Quality management system is primarily involved in ensuring good manufacturing practice (cGMP), good laboratory practice (GLP), good documentation practice (GDP), good automated manufacturing practice (GAMP) etc. The quality risk management framework is ingrained in its definition.

Documentation

Documentation Communication Method Validation Packaging

Small Change: FDA’s Final Predetermined Change Control Plan (PCCP) Guidance Ditches ML and Adds Some Details, But Otherwise Sticks Closely to the Draft

FDA Law Blog: Biosimilars

FEBRUARY 13, 2025

FDA provides definitions for the three datasets. Although data scientists sometimes refer to the tuning dataset as the validation dataset, FDA encourages using terminology consistent with the Agencys Artificial Intelligence Glossary. Update practices and training of end users also need to be addressed.

Documentation

Documentation Labelling Method Validation Communication

Pharmacist Digest

What is quality risk management in pharmaceutical?

Small Change: FDA’s Final Predetermined Change Control Plan (PCCP) Guidance Ditches ML and Adds Some Details, But Otherwise Sticks Closely to the Draft

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