GMPSOP

MARCH 4, 2023

According to FDA Guidance for Industry – Q9 Quality Risk Management , “Quality risk management is a systematic process for the assessment, control, communication and review of risks to the quality of the drug product across the product lifecycle. If my cleaning methods are not validated would they cause contamination of my products?

Documentation 52

Documentation Communication Method Validation Packaging 52

GMPSOP

JULY 23, 2023

Challenges include inadequate preparation, poor documentation, insufficient resource allocation, and lack of clear communication. Validation of testing methods: Validate all testing methods used during the qualification process to ensure the accuracy and reliability of results.

Documentation 52

Documentation Method Validation Packaging Labelling 52

FDA Law Blog: Biosimilars

FEBRUARY 13, 2025

The manufacturer should, in addition to stating whether the modification will be implemented manually or automatically, include details such as: End user actions needed, if any to implement the change, Timing of implementation, Extent of implementation in the install base, and Include references to expected labeling changes.

Documentation 71

Documentation Labelling Method Validation Communication 71