The leading journal for specialists and managers in pharmaceutical manufacturing and quality assurance
22.11.2021
Why even highly qualified auditors can still be incompetent. Please read more here
Read more … What makes a good GMP Auditor?
Why a practical framework is key to the R&D process of any cell-based ATMP. Please read more here
Read more … Cell by Design (CbD)
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 … Demonstrating Method Suitability for an ATP-bioluminescence Rapid Microbial Detection Method for Biologic Products
Requirement Landscape across Europe from a QP's Perspective. Please read more here
Read more … Compassionate Use and other Managed Access Concepts
Concept and Establishment of Established Conditions (EC) and of the Product Lifecycle Management (PLCM) Document. Please read more here
Read more … ICH Q12 Pharmaceutical Product Lifecycle Management
02.08.2021
When does a marketing authorisation holder have to comply with GMP? Please read more here
Read more … Good Manufacturing Practice and the Marketing Authorisation Holder
Specifications for labelling with machine-readable codes. Please read more here
Read more … Prescription medicines in Japan
A summary of the last APIC/Cefic Global GMP & Regulatory API Conference, which took place in October 2020. Please read more here
Read more … Highlights of the 23rd Active Pharmaceutical Ingredients Conference of APIC
This article based on the presentation by David Cockburn, EQPA Board, at the QP Forum 2020. Please read more here
Read more … Frequently Asked Questions by QPs - the EQPA Discussion Forum
Recognising and influencing three of the key features of quality culture. Please read more here
Read more … Quality culture
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