All GMP and quality management systems (QMS) articles – Page 3
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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.
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WebinarSimplifying complex dosage forms with advanced encapsulation
This webinar explores the unique manufacturing challenges of multi-formulation capsules and how these dosage forms can enhance treatment efficacy and patient compliance.
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ArticleEuropean Pharmaceutical Review Issue 3 2024
European Pharmaceutical Review Issue 3 includes articles on microbiology, downstream bioprocessing and drug development. Register your details now to download this exclusive content.
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ArticleDrug approval roundup – May/June 2024
This article highlights some of the key regulatory approvals granted in May and June in the EU and US so far this year, including for oligonucleotide and biologic therapies.
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WhitepaperOne HEK of a viral vector to develop
Viral vector manufacturing presents many challenges related to HEK cell line development, fluid transfer and product viability in the cold chain.
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NewsOptimising iPS cell-based platelet manufacturing scale up
Large-scale platelet manufacturing must consider turbulent energy and shear stress as well as the undesired turbulent flow space within a bioreactor, the paper concluded.
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NewsWHO proposes recommendations for preventing nitrosamine contamination
The World Health Organization (WHO)’s draft guidance on nitrosamines is applicable to manufacturers of excipients, active pharmaceutical ingredients (APIs) and finished pharmaceutical products.
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NewsBenefits of 3D printing for personalised medicine formulation
A study has demonstrated how 3D printing can be used to manufacture tailored, safe, and effective treatments for patients with rare diseases via pharmaceutical compounding.
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NewsSeasonal variation of microbial contamination in pharmaceutical cleanrooms
With the outdoor environment being a primary contamination source in the pharmaceutical cleanroom, measures like good manufacturing practices (GMP) is key to reduce this risk, a paper asserts.
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NewsQuality risk management in radiopharmaceutical production
A quality risk assessment of a Good Manufacturing Practice (GMP) radiopharmaceutical production site found that dispensing was the most critical phase of the process.