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USP’s proposed new Chapter < 86 >, which offers additional information on Bacterial Endotoxins Tests (BETs) using non-animal derived reagents, has been published as a General Announcement in advance of public consultation.
This white paper looks at the environmental impact of plate count testing and how on-line microbial detection supports sustainable pharma manufacturing.
Nitrosamine genotoxins in several pharmaceuticals has led to monitoring of manufacturing practices for products considered at risk.
Nitrosamine impurities have become a concern in the bio/pharmaceutical industries, due to their carcinogenic properties and presence in medications.
Discover the benefits of liquid-filled capsules for the formulation of highly potent APIs and drugs that benefit from slow or extended release.
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.
Several FDA warning letters distributed to pharmaceutical manufacturers in 2023 have warned of numerous corrective and preventive action (CAPA) compliance concerns.
The European Pharmacopoeia (Ph. Eur.) Commission's new European monograph for Cannabis flower will enter into force in July 2024.
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.
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.
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.
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.
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”.
EPIQ is a single platform for Quality, Document, and Learning Management. It offers integration across departments for a seamless quality management.
The European Medicines Agency (EMA) has updated its guidance on nitrosamine impurities in human medicinal products, amending Q&A 10 and adding three appendices.
