GMP Trends and Analyses!

The leading journal for specialists and managers in pharmaceutical manufacturing and quality assurance

The Present and Future of Remote Audits

The Present and Future of Remote Audits

How will distant assessments be able to complement on-site audits? Please read more here

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The most Frequent GMP Deficiencies in Quality Control

The most Frequent GMP Deficiencies in Quality Control

An analysis of the Warning Letters of the last 5 years. Please read more here

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Common and Typical GDP Violations

Common and Typical GDP Violations

An Evaluation of GDP Non-Compliance Reports since 2014. Please read more here

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Stability testing for medical Cannabis - What needs to be considered

Stability testing for medical Cannabis - What needs to be considered

Stability is defined as the extent to which a product retains, within specified limits, the same properties and characteristics that it possessed at the time of its manufacture and release throughout its period of storage and use (i.e., its shelf-life). Please read more here

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GMP Trends 2021/2022

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

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QP Qualification Requirements in different Member States

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

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ICH Q12 Pharmaceutical Product Lifecycle Management – Part II

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

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Ventilation and Air-Conditioning Systems

Ventilation and Air-Conditioning Systems

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

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Trends Identification and Analysis

Trends Identification and Analysis

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

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