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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.
This in-depth focus includes articles exploring the 10 key considerations when designing an ATMP manufacturing facility and the potential benefits of implementing continuous bioprocessing and biomanufacturing.
How to replace manual handling of pharmaceutical powders and tablets with automation to pave the way for continuous manufacturing.
This webinar considers the problems bacterial and fungal spores present for contamination control and remediation and disinfection strategies.
This whitepaper outlines the important components of an environmental monitoring programme, providing practical advice and best practice guidance.
All-in-one Drug Anti-Counterfeit Solution for improved pharma product security and brand protection, brought to big pharma companies via tec5USA.
See how QC analysts can easily set up fully compliant 21-sample BET assays in 9 minutes with less than 30 pipetting steps.
Want easy automation of BET assays and high throughput? Watch the video to see fast BET assay setup with centripetal microfluidic automation.
The new general chapter, Balances for analytical purposes (2.1.7), sets out clear requirements for equipment that is the cornerstone of every analytical procedure in the European Pharmacopoeia.
Explore the cost comparisons, risk reduction, and increased support that arise when using Sievers Certified Reference TOC Standards.
This application note addresses the TOC limit changes in USP for packaged water. The new limits account for varying container volumes.
![Researcher looking at an experiment [Credit: Unsplash].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/Bell-advanced-therapies-feature-300x278.jpg)
![Researcher looking at an experiment [Credit: Unsplash].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/Bell-advanced-therapies-feature.jpg)
Advanced therapies are a ground-breaking new class of medicines that use gene therapy, cell therapy or tissue engineering to treat disease and injury. Rachel Bell, Trainee Patent Attorney at Marks & Clerk, and Ceri Roberts, Scientific Training Manager – Cellular and Molecular Therapies at NHS Blood and Transplant, discuss some…
This worksheet can be edited to include specifications discovered during your evaluation of Alternative Rapid Microbiological Method Technologies.
In this whitepaper, C2C’s Product & Process Development Lead explains how using digital modelling in the design process can guarantee results.
Adare’s Optimµm® technology offers a unique and efficient method of fabricating monodisperse microparticles at reduced development time.
Learn how you can go about changing QC test methods and how this can go a long way to helping your lab achieve data integrity compliance.
