GMP Trends and Analyses!

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

Successful Communication in Audits

Successful Communication in Audits

Using verbal and non-verbal communication goal-oriented. Please read more here

Read more …

What makes a good GMP Auditor?

What makes a good GMP Auditor?

Why even highly qualified auditors can still be incompetent. Please read more here

Read more …

Cell by Design (CbD)

Cell by Design (CbD)

Why a practical framework is key to the R&D process of any cell-based ATMP. Please read more here

Read more …

Demonstrating Method Suitability for an ATP-bioluminescence Rapid Microbial Detection Method for Biologic Products

Demonstrating Method Suitability for an ATP-bioluminescence Rapid Microbial Detection Method for Biologic Products

This article addresses the perceived limitations using ATP-bioluminescence as an alternative test method for detecting microbial contaminants in samples that contain cells or cellular material. Please read more here

Read more …

Compassionate Use and other Managed Access Concepts

Compassionate Use and other Managed Access Concepts

Requirement Landscape across Europe from a QP's Perspective. Please read more here

Read more …

ICH Q12 Pharmaceutical Product Lifecycle Management

ICH Q12 Pharmaceutical Product Lifecycle Management

Concept and Establishment of Established Conditions (EC) and of the Product Lifecycle Management (PLCM) Document. Please read more here

Read more …

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

Read more …

Prescription medicines in Japan

Prescription medicines in Japan

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

Read more …

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 October 2020. Please read more here

Read more …

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

Read more …

To-Top
To-Bottom