pharmaphorum

DECEMBER 16, 2021

Gain insight the current state of Endotoxin testing, including alternative test methods and strategic approaches to method validation. Key Reasons to Attend: Discover case studies in establishing holistic Contamination Control Strategies and Real-Time Viable Air Particle Counting with leaders in the pharmaceutical industry.

Method Validation 52

Method Validation 52

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

European Pharmaceutical Review

JANUARY 26, 2023

The European Medicines Agency (EMA) has published an updated Q&A document regarding ICH M10 ‘Bioanalytical Method Validation and Study Sample Analysis’. The ICH M10 guideline provides recommendations on the validation of bioanalytical assays for chemical and biological drugs and their metabolites in biological matrices.

Method Validation 98

Method Validation Documentation FDA 98

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

The FDA Law Blog

FEBRUARY 13, 2025

FDA recommends that the following information be made public regarding the PCCP as appropriate: planned modifications, testing methods, validation activities and performance requirements to meet before implementation, and means by which users will be informed of the implementation of the modification.

FDA 71

FDA Documentation Labelling Method Validation 71