All GMP and quality management systems (QMS) articles – Page 3
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ArticleEuropean Pharmaceutical Review Issue 1 2025
EPR Issue 1 includes articles on manufacturing, drug delivery, process analytical technology (PAT), RNA therapeutics and more.
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NewsFDA sends warning letter to KVK-Tech manufacturing facility
A warning letter has been sent by the US FDA to KVK-Tech regarding cGMP violations at their drug manufacturing site, including for data integrity.
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WebinarHow a well-orchestrated digital ecosystem drives laboratory efficiency and innovations
Find out how to take advantage of a connected digital ecosystem to enhance quality control, streamline manufacturing and, ensure regulatory compliance
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WebinarBenchtop NMR for continuous process monitoring in PAT
Discover how Bruker Benchtop NMR integrates with synTQ software, enhancing process monitoring and complementing IR and Raman techniques in the PAT framework
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WhitepaperNSF Launches ‘Compliance Unlocked’ Podcast Series
NSF invites pharmaceutical professionals to tune in to its new groundbreaking podcast series “Compliance Unlocked” and join the conversation on critical industry issues.
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WhitepaperNSF’s quality management maturity (QMM) assessment model
NSF’s quality management maturity (QMM) assessment model: future-proofing quality and supporting supply chain robustness
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ReportPharma Horizons: Sustainability
European Pharmaceutical Review’s latest Pharma Horizons report provides insight on key sustainability developments in the pharmaceutical industry and covers topics including regulation, manufacturing and clinical development.
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WhitepaperRegulatory Authority Inspection Comparison
A guide on what to expect during a regulatory inspection and the differences in the approach taken by three of the main regulatory authorities and PIC/S.
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WhitepaperWhitepaper: Optimise organisational culture & quality maturity
Whitepaper - Optimising organisational culture and quality maturity is crucial in promoting consistent, reliable business processes and to minimise supply disruptions.
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WebinarWhen innovative formulations cloud sterility testing
Webinar presented by Miriam Guest, Senior Principal Scientific Advisor at Charles River, to explore how ATP-bioluminescence outperforms traditional sterility testing in complex matrices.
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ArticleAdvancing environmental monitoring systems for CGT manufacturing
Gill Lewis, QP and Chief GMP Consultant, eXmoor Pharma. discusses the company's approach to environmental monitoring and the key challenges faced during integration at its Cell and Gene Therapy Centre in Bristol, a facility which received a GMP license from the MHRA in August.
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ArticleHow ready are you? Preparing for the impact of EU GMP Annex 1 on primary packaging
This feature partnership covers how pharma companies can ensure they are end-to-end compliant with Annex 1 for their primary packaging via a robust CCS.
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ArticleEnvironmental Monitoring In-Depth Focus 2024
This in-depth focus explores environmental monitoring of compressed gas ports and best practice for minimising contamination risks.
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ArticleEuropean Pharmaceutical Review Issue 4 2024
European Pharmaceutical Review Issue 4 includes articles on regulation, bioproduction, environmental monitoring, packaging and drug delivery.
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NewsPharmaLab Congress 2024 - what’s new for the third year in Düsseldorf/Neuss
Find out what is on offer for pharma professionals working in analytical development and microbiology QC at the 12th PharmaLab Congress being held in Germany in 2024.
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WhitepapereBook: Successfully navigating complex and evolving regulatory environment for combination products
With complex processes and stringent regulatory requirements, the path to developing a combination product can be uncertain and challenging
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ArticleAre we set for the revised EU GMP Annex 1?
This blog is a summary of the key changes of relevance to primary packaging components seen in the latest iteration of EU GMP Annex 1.
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WhitepaperScience of scale for spray-dried intermediates
Speed to market is a critical aspect of developing new pharmaceutical products, and scale-up – or scale-down – can play a key part in that process.
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WebinarSimplify your move from a vial to a prefilled syringe
This webinar explores the key considerations in component selection when moving from a vial to a prefilled syringe during biologic drug development.
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WhitepaperSynthesis and Route Design to Tackle API Complexity
These longer synthetic pathways present challenges for process chemists hoping to achieve an efficient API manufacturing process.