GMP Trends and Analyses!

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

GMP-compliant equipment design: The GMP Equipment Design Guide

GMP-compliant equipment design: The GMP Equipment Design Guide

There are no specific regulatory requirements for what constitutes as good equipment design. The new ECA GMP Equipment Design Guide provides guidance. Please read more here

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Data flows, Data Lifecycle, and ALCOA+

Data flows, Data Lifecycle, and ALCOA+

This article provides insight into the collection, assessment and application of data. Please read more here

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Cross-contamination and Sustainability: The Trouble with Contamination

Cross-contamination and Sustainability: The Trouble with Contamination

How can the two hot topics of cross-contamination and sustainability in pharmaceutical operations be balanced out? Please read more here

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Developments on GMP Classification of Fiscal Imports

Developments on GMP Classification of Fiscal Imports

How does the new Annex 21 to Eudralex Vol. 4 influence fiscal importation? Please read more here

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Highlights of the 24th Active Pharmaceutical Ingredients Conference of APIC

Highlights of the 24th Active Pharmaceutical Ingredients Conference of APIC

A summary of the last APIC/Cefic Global GMP & Regulatory API Conference, which took place inOctober 2021. Please read more here

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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 FDA Warning Letter Report 2021

The FDA Warning Letter Report 2021

An analysis of the Warning Letters of Fiscal Year 2021 and 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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