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In this Q&A, Laure Pomares Voisin, Quality Director, Catalent Biologics and Tony Cundell Principal Consultant, Microbiological Consulting, LLC discuss some of the key microbiology and environmental monitoring challenges and trends in pharmaceutical manufacturing today.
A key part of Annex 1, due to come into effect on 25 August 2023, is the development of a holistic contamination control strategy (CCS). In this article, EPR’s Caroline Peachey summarises an expert panel discussion, which explored common challenges in implementing a CCS and made several recommendations.
An innovative, chemosensor-based method for detection of lipopolysaccharide (LPS) is set to facilitate development of a rapid online-endotoxin monitor.
The pharma industry’s adaptation to Industry 4.0 has been slow, due to the extensive regulatory requirements imposed on manufacturers. However, regulatory agencies are starting to embrace movement towards more rapid/automated systems, as illustrated in the revised EU GMP Annex 1, which entered into force in August. Here, Isabella Jul-Jørgensen from the Technical…
In this in-depth focus, explore how automation is transforming environmental monitoring in line with Annex 1, implementation of contamination control strategies and discover the emerging trends and challenges in pharmaceutical microbiology.
Dave Elder explores evolving concerns surrounding nitrosamine-related impurities while calling for continued collaboration to harmonise regulatory approaches.
EPR Issue 4 includes articles on fridge-free vaccines, dry powder drug delivery, Annex 1, contamination control strategy and more.
IMA Pharma showcases its extensive, all-in-one vaccine production solutions, including the design and development of complete aseptic lines and secondary packaging, all facilitated by the latest advanced technologies.
Advanced analytical technologies in quality control (QC) processes in cell and gene therapy manufacturing is anticipated to help deliver a 24.6 percent market CAGR between 2023 and 2031.
A study incorporating new methodologies has described a stratified sampling procedure used for analyte response evaluation in pharmaceutical migration studies.
The much-anticipated Annex 1 revision is finally operational; manufacturers in the EU must be compliant with the GMP guideline updates when manufacturing sterile medicinal products.
25 August 2023 | By Mastercontrol
Watch this webinar to learn about the current state of digitisation in life sciences and where your peers rank on the quality digital maturity spectrum.
To address the perceived barrier to entry for rapid microbiological methods, new validation packages are now available for Celsis® rapid microbial detection.
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.
