GMP Trends and Analyses!

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

Good Manufacturing Practice and the Marketing Authorisation Holder

Good Manufacturing Practice and the Marketing Authorisation Holder

When does a marketing authorisation holder have to comply with GMP? Please read more here

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Prescription medicines in Japan

Prescription medicines in Japan

Specifications for labelling with machine-readable codes. Please read more here

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Highlights of the 23rd Active Pharmaceutical Ingredients Conference of APIC

Highlights of the 23rd Active Pharmaceutical Ingredients Conference of APIC

A summary of the last APIC/Cefic Global GMP & Regulatory API Conference, which took place in December 2020. Please read more here

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Frequently Asked Questions by QPs - the EQPA Discussion Forum

Frequently Asked Questions by QPs - the EQPA Discussion Forum

This article based on the presentation by David Cockburn, EQPA Board, at the QP Forum 2020. Please read more here

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Quality culture

Quality culture

Recognising and influencing three of the key features of quality culture. Please read more here

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Preparing for a data integrity inspection

Preparing for a data integrity inspection

Data integrity is one of the more recent, though still important, areas of interest in pharmaceutical company inspections. Please read more here

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Cleaning Validation Q&A

Cleaning Validation Q&A

A selection of Q&As answered during the Live Online Training Cleaning Validation in September 2020. Please read more here

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The long and winding Road of the Annex 1 Revision

The long and winding Road of the Annex 1 Revision

The first draft of the current revision was already published for comment on December 20, 2017. What has happened since then? Please read more here

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How to save Time and Money in International Equipment Qualification Projects?

How to save Time and Money in International Equipment Qualification Projects?

The regulations with regard to Qualification and Validation are different in the US, in Europe in China and other countries. Please read more here

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