GMP Trends and Analyses!

28.03.2022

ICH Q12 Pharmaceutical Product Lifecycle Management – Part II

Concept and Establishment of Established Conditions (EC) and of the Product Lifecycle Management (PLCM) Document. Please read more here

28.03.2022

Ventilation and Air-Conditioning Systems

Performance of Hygiene Inspections according to VDI 6022. Please read more here

28.03.2022

Trends Identification and Analysis

Th e ECA Guidance on OOE and OOT Results. Please read more here

28.03.2022

New Publication - ECA's Good Practice Guideline Integrated Qualification and Validation

A guide to effective Qualification based on Customer – Supplier Partnership Version 2.0. Please read more here

28.03.2022

ICH Q7 Compliance Week

The Live Online ICH Q7 Training Week. Please read more here

Microbiological Suitability Tests of Non-Sterile Preparations

What do the harmonised chapters 2.6.12 of the Ph.Eur.or USP chapter <61> define in terms of testing non-sterile preparations or for microbiological purity? Please read more here

22.11.2021

Successful Communication in Audits

Using verbal and non-verbal communication goal-oriented. Please read more here

22.11.2021

What makes a good GMP Auditor?

Why even highly qualified auditors can still be incompetent. Please read more here

22.11.2021

Cell by Design (CbD)

Why a practical framework is key to the R&D process of any cell-based ATMP. Please read more here

Demonstrating Method Suitability for an ATP-bioluminescence Rapid Microbial Detection Method for Biologic Products

This article addresses the perceived limitations using ATP-bioluminescence as an alternative test method for detecting microbial contaminants in samples that contain cells or cellular material. Please read more here