ICH Q6(R1): test criteria and specifications
Dave Elder shares industry thoughts on an ICH Q6(R1) concept paper that aims to revise general principles for uniformity and consistency across ICH Q6 guidelines for test criteria and specifications.
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Dave Elder shares industry thoughts on an ICH Q6(R1) concept paper that aims to revise general principles for uniformity and consistency across ICH Q6 guidelines for test criteria and specifications.
18 December 2024 | By MasterControl
This webinar explores the major trends impacting life sciences in 2025 and how the pharma industry can capitalise on the latest developments shaping quality management.
A total of DKK 8.5 billion will fund the new production facility in Odense, Denmark, which is set to facilitate the manufacture of medicines for rare diseases.
The innovative line of barrier bottles provides unmatched protection against moisture and oxygen and reduces production costs, LOG Pharma Primary Packaging says.
10 December 2024 | By
NSF’s quality management maturity (QMM) assessment model: future-proofing quality and supporting supply chain robustness
9 December 2024 | By European Pharmaceutical Review
During this virtual panel, industry experts will explore the latest advances in environmental monitoring, discuss key challenges within the sector and approaches that can prevent and mitigate these issues.
The partnership will provide biotech companies with accelerated access to clinical development capabilities, including drug development and analytical services.
IMA Pharma discusses approaches to keeping Amoxicillin and Clavulanic Acid tablets stable and effective by addressing moisture sensitivity and preventing degradation.
The Association of the British Pharmaceutical Industry (ABPI) asserts that the recommendations will help generate confidence and predictability in medicine regulation in the UK.
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.
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.
This in-depth focus features articles on environmental monitoring trends such as digitalised management of EM data, as well as endotoxin detection.
This application note explores rapid microbial methods and balancing patient care, quality products, and safe shelf lives for unique formulations.
European Pharmaceutical Review Issue 5 includes articles on bioprocessing, biologics, sustainability, and drug formulation.
With a growing pipeline of biologics, increase in vaccine production, and small batch sizes targeting small patient populations, there’s increasing demand for advanced manufacturing tech.