GMP Trends and Analyses!

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

PharmaCongress: On the Pulse of Industry for 25 Years

PharmaCongress: On the Pulse of Industry for 25 Years

What originally began as a pharmaceutical technology conference has grown to become the most important international meeting place for the pharmaceutical industry. And as early as 1989, the 1st PharmaCongress focused on the topic of GMP/FDA-compliant facility design and was very well received. Please read more here

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ECA Qualification and Validation Forum

ECA Qualification and Validation Forum

A look back at the Qualification and Validation Forum in November 2022. Please read more here

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Questions and Answers to Cloud Computing in a GxP Environment

Questions and Answers to Cloud Computing in a GxP Environment

Nine experts from the pharmaceutical industry and regulatory authorities answer frequently asked questions on cloud computing. Please read more here

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Questions and Answers about Cleaning Validation - Part 1

Questions and Answers about Cleaning Validation - Part 1

Speaker Robert G. Schwarz answers frequently asked questions about cleaning validation. Please read more here

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Questions and Answers on (Reduced) Sampling

Questions and Answers on (Reduced) Sampling

Regulatory requirements, sample drawing and prerequisites for reduced sampling. Please read more here

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Annex 1 Revision

Annex 1 Revision

Consideration of some relevant points of the final version. Please read more here

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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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