whitepaper
Whitepaper: Are nitrosamines a concern for biologic manufacturers?
Nitrosamine genotoxins in several pharmaceuticals has led to monitoring of manufacturing practices for products considered at risk.
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QA/QC
whitepaper
Whitepaper: Navigating nitrosamine impurity testing
Nitrosamine impurities have become a concern in the bio/pharmaceutical industries, due to their carcinogenic properties and presence in medications.
whitepaper
ebook: Benefits of liquid-filled capsules for pharmaceutical development
Discover the benefits of liquid-filled capsules for the formulation of highly potent APIs and drugs that benefit from slow or extended release.
webinar
Advantages of automated microbial colony counting
16 August 2023 | By Rapid Micro Biosystems
Watch this webinar with independent microbiology expert Dr Tim Sandle to explore the different technologies, regulatory concerns and validation requirements for automated colony counting methods.
news
FDA warning letters highlight CAPA concerns
Several FDA warning letters distributed to pharmaceutical manufacturers in 2023 have warned of numerous corrective and preventive action (CAPA) compliance concerns.
news
New European monograph for Cannabis flower adopted
The European Pharmacopoeia (Ph. Eur.) Commission's new European monograph for Cannabis flower will enter into force in July 2024.
news
Harnessing continuous improvement in the CAPA process
In a risk-based framework for implementing a corrective and preventive action (CAPA) process, a continuous improvement approach is proposed as a way to drive higher product quality and improve patient safety.
news
MHRA authorises new COVID-19 vaccine
The new COVID-19 vaccine authorised by the Medicines and Healthcare products Regulatory Agency (MHRA) contains an adjuvant and is indicated to be given to patients over 16 years.
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Accelerating biomanufacturing with automated PAT systems
Experts at Amgen have highlighted a micro sequential injection (µSI) process analyser and automatic assay preparation platform (A2P2) as an autonomous process analytical technology (PAT) platform to enable rapid testing and release of biopharmaceutical products.
webinar
Analysis of impurities in pharmaceuticals using ion chromatography
2 August 2023 | By Metrohm
This webinar highlights the importance of impurity testing in pharmaceuticals and how ion chromatography can provide excellent sensitivity and selectivity when testing for ionic impurities.
news
Paper reports on QbD in bilayer tablet development
A paper has stated that applying the quality by design (QbD) principle during development of bilayer tablets will “help improve product design while also enhancing the quality, safety, and efficacy of drug products”.
whitepaper
Whitepaper: EPIQ – Solution Brief
EPIQ is a single platform for Quality, Document, and Learning Management. It offers integration across departments for a seamless quality management.
news
EMA revises guidance on nitrosamine impurities
The European Medicines Agency (EMA) has updated its guidance on nitrosamine impurities in human medicinal products, amending Q&A 10 and adding three appendices.
news
Establishing quality assurance in personalised preparations
A paper has highlighted a drug product quality assurance programme for personalised preparations, including application of a preventive or corrective measures (CAPA) system.
news
Determining accurate estimation of true endotoxin concentration
Research suggests that performing LAL gel clot tests and narrowing the dilution range can provide good estimation of endotoxin concentration in pharmaceuticals.
