GMP Trends and Analyses!

28.03.2022

GMP Trends 2021/2022

What has changed in the GMP environment in 2021 and will affect 2022? The highlights are summarised in this article. Please read more here

QP Qualification Requirements in different Member States

QPs are expected to be qualified by education at university degree level and by demonstrating additional defined minimum practical experience. How to they meet these expectations? Please read more here

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