The leading journal for specialists and managers in pharmaceutical manufacturing and quality assurance
22.11.2021
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
The tricky issue of exposure times. Please read more here
Read more … Validation of disinfection procedures in aseptic manufacturing
16.03.2021
Data integrity is one of the more recent, though still important, areas of interest in pharmaceutical company inspections. Please read more here
Read more … Preparing for a data integrity inspection
A selection of Q&As answered during the Live Online Training Cleaning Validation in September 2020. Please read more here
Read more … Cleaning Validation Q&A
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