European Pharmaceutical Review

JANUARY 25, 2024

Leachable studies leachables can stem from different sources and be formulation dependent” “Because leachables can stem from different sources and be formulation dependent” sufficient data should be provided to identify and characterise the potential risks associated with the leachables from the CCS.

FDA 98

FDA Documentation Method Validation Packaging 98

Pharmaceutical Technology

AUGUST 24, 2022

To ensure the quality of FCM assay performance in preclinical and clinical applications, several scientific organizations developed recommendations for FCM instrumentation and method validation. The FDA and/or other regulatory agencies typically request validation reports to evaluate the assay performance for the intended purpose.2,3.

Method Validation 52

Method Validation Immunization FDA 52

ISPE

MAY 10, 2023

The ISPE QC/Analytical CoP was established in 2022 to provide a forum for knowledge sharing on a range of topics including out of specification (OOS) investigations, method validation, compendial harmonization, analytical methods lifecycle management, and implementing innovations, such as real-time release.

Method Validation 52

Method Validation FDA 52

ISPE

JANUARY 11, 2023

The cleaning validation life-cycle approach consists of three stages: design, qualification, and continued verification. Often referred to as the validation stage, stage two: qualification confirms that the cleaning procedure under normal conditions meets preestablished acceptance criteria.

Method Validation 52

Method Validation Documentation Packaging Compounding 52

ISPE

MAY 9, 2023

ANVISA’s analytical method validation 15 and forced degradation 1 requirements are examples of those local regulations that bring additional technical requirements and make a Brazil dossier different from a US or EU dossier (both ICH member countries) and drive the divergence between harmonized global registration process.

Documentation 52

Documentation Packaging Pharmaceutical Companies Pharmaceutical Companies 52

ISPE

AUGUST 29, 2022

As part of the change management process, personnel must manually find, view, and interpret the older data sets to establish a frame of reference for completing method validation exercises and compare the initial and optimized assays.

Documentation 52

Documentation FDA Communication Packaging 52