All GMP and quality management systems (QMS) articles
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ArticleRedefining the standard for recessed lighting in the pharmaceutical industry
Pharmaceutical and chemical manufacturing facilities present some of the most demanding lighting challenges in industry, combining explosive atmospheres, stringent hygiene requirements and complex regulatory requirements. Raytec examines how explosion-protected LED solutions are redefining safety, performance and compliance across hazardous area applications.
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ArticleThe next frontier in nitrosamine testing: detection and risk assessment in packaging and IV infusion bags
Join Waters Corporation on the 23rd September for their webinar on the latest developments in nitrosamines testing, evolving regulatory expectations, analytical challenges, and advanced LC-MS/MS strategies for sensitive detection and risk assessment.
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WebinarFrom passive to active air monitoring in aseptic filling: a risk-based approach to replacing settle plates
In this webinar, Particle Measuring Systems will share a case study of a biopharmaceutical company developing and applying a structured global rationale for the implementation of continuous viable environmental monitoring with a single-use microbial impactor within aseptic manufacturing environments.
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ArticleLab 4.0 balance: connected, compliant and ready to integrate
Combining connectivity, compliance and automation, Lab 4.0 connectivity simplifies workflows, reduces manual intervention and supports secure digital transformation in modern pharmaceutical laboratories.
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WebinarModernising pharma QA/QC laboratories: preparing for a more connected, compliant future
Join this webinar to discover how modern QA/QC laboratories are embracing digital transformation to enhance compliance, workflows and data integrity to build a more connected, future-ready pharmaceutical quality ecosystem.
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WebinarRegulatory shifts ahead: preparing for EU pharmaceutical reform and FDA changes
With the EU’s pharmaceutical legislation reform soon to come into force, regulatory experts outline what is changing across both US and European frameworks and how sponsors can position pipelines ahead of implementation.
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ArticleWhat Annex 22 spells for AI in GMP manufacturing
Europe’s first dedicated framework for artificial intelligence in GMP manufacturing is close to finalisation and it is more demanding and more consequential than many manufacturers may currently appreciate.
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ArticleImplementing horizontal recycling for pharmaceutical release liners
Closed-loop backing paper recycling enables manufacturers to convert release liner waste into circular materials without modifications to existing printers or labellers, meanwhile ensuring EU packaging waste regulation compliance.
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NewsDay one in focus: rethinking QA/QC at The Future of Bio/Pharmaceutical Analysis 2026
The Future of Bio/Pharmaceutical Analysis Virtual Summit returns 23–25 June 2026 with an opening day dedicated entirely to quality assurance and control. Three expert-led panel sessions will address environmental monitoring modernisation, endotoxin testing transformation and contamination control optimisation—examining how QA/QC disciplines are adapting to advanced therapies, sustainability demands and evolving regulatory expectations including Annex 1 implementation.
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ArticleOptimising the downstream process in lentiviral vector manufacturing
Sartorius BIA Separations illustrates a promising alternative approach for efficient lentiviral vector purification that delivers a scalable, GMP-ready biomanufacturing solution.
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WebinarPractical steps for innovating pharmaceutical manufacturing
In this webinar, industry experts discussed practical examples and considerations for transforming manufacturing processes.
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WebinarPractical considerations for aseptic gowning in contamination control strategies
Watch this webinar as we examine the main personnel-related factors that could lead to particle/microbial contamination risks of the product and outline practical measures that can mitigate these risks.
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NewsEMA opens consultation for Annex 15 GMP guidelines
Proposal guideline by EMA anticipated to replace Eudralex Volume 4: Annex 15 Qualification and validation.
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WebinarSmarter Raman QC for biopharma fill-finish with scalable model transfer
Join this webinar to explore how modern Raman spectroscopy is transforming biopharma fill-finish quality control through faster analysis, multi-attribute insight, and scalable model transfer.
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ArticleReiThera on vaccines and remaining nimble around emerging threats
As vaccines are buffeted by political pressures, the CDMO discussed its growth approach and some of its key collaborations.
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NewsChitose and Fujifilm Biosciences sign biopharma manufacturing alliance
The deal will see the companies combine their respective work on CHO-MK cells and GMP-manufactured culture media.
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ArticleA four-step way out of pharma manufacturing's asset management struggles
Here, Hexagon outlines a four-step plan to address silos and scale-up challenges, drawing on the experience of leading pharma firms like Pfizer.
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WebinarIncreasing the effectiveness of pharma endotoxin testing
During this virtual panel, industry experts will discuss the evolution of endotoxin testing, future trends and key risk mitigation considerations for pharma companies.
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ArticleHEATMOS filter technology for depyrogenation tunnels – innovations for extreme conditions
Nippon Muki demonstrates the performance advantages of its innovative HEPA filter for the sterilisation of injectable containers in pharmaceutical manufacturing.
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WebinarRealising autonomous pharmaceutical operations
Is operational complexity limiting your performance? Discover how autonomous technologies are reducing risk and improving quality in pharma organisations.