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NSF’s quality management maturity (QMM) assessment model
10 December 2024 | By
NSF’s quality management maturity (QMM) assessment model: future-proofing quality and supporting supply chain robustness
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Good Manufacturing Practice (GMP)
Good manufacturing practices (GMP) are the practices required in order to conform to the guidelines recommended by agencies that control authorisation and licensing for manufacture and sale of drug products and active pharmaceutical products. These guidelines provide minimum requirements that a pharmaceutical manufacturer must meet to assure that the products are of high quality and do not pose any risk to the consumer or public.
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Pharma 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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Regulatory Authority Inspection Comparison
26 November 2024 | By
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.
whitepaper
Whitepaper: Optimise organisational culture & quality maturity
31 October 2024 | By NSF
Whitepaper - Optimising organisational culture and quality maturity is crucial in promoting consistent, reliable business processes and to minimise supply disruptions.
webinar
When Innovative Formulations Cloud Sterility Testing
30 October 2024 | By Charles River
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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Advancing 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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How 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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Environmental 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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European 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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PharmaLab 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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eBook: 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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Are we set for the revised EU GMP Annex 1?
23 August 2024 | By
This blog is a summary of the key changes of relevance to primary packaging components
whitepaper
Science of scale for spray-dried intermediates
5 August 2024 | By
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.
webinar
Simplify your move from a vial to a prefilled syringe
30 July 2024 | By West Pharmaceutical Services
This webinar explores the key considerations in component selection when moving from a vial to a prefilled syringe during biologic drug development.
whitepaper
Synthesis and Route Design to Tackle API Complexity
22 July 2024 | By
These longer synthetic pathways present challenges for process chemists hoping to achieve an efficient API manufacturing process.
