news
Using UHPLC-MS/MS for trace detection of β-lactam antibiotics
Researchers demonstrate ultra high performance liquid chromatography with triple quadrupole mass spectrometry to detect and quantify trace amounts of cephapirin and ceftiofur.
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Good Manufacturing Practice (GMP)
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.
article
Innovation in pharma manufacturing quality systems
Over the last 10 years, there has been an important change of focus in pharma towards biotech products and personalised therapies. These important new treatments are now emerging into manufacturing, with implications for the way that quality is monitored, managed and assured. Dr Eduard Cayón sets out some practical advice.
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GAMP 5 update: computerized system expectations for pharma manufacturers
The International Society of Pharmaceutical Engineering’s GAMP® 5 guidelines steer validation practices for pharma companies to meet computerized system expectations. Members of the GAMP steering committees, Lorrie Schuessler, Charlie Wakeham and Stephen Ferrell, share the some of the key changes in the second edition update and how these should be…
news
Swedish innovation agency invests in new ATMP QC method
A new project funded by Swedish innovation agency Vinnova, will help develop an AI-based quality control method for ATMP manufacturing.
whitepaper
Case study: Reduce plate counting costs and delays
Learn how a US influenza vaccine manufacturer concerned with intermittent positive plate counts used rapid microbial monitoring to save time and money.
whitepaper
Under the microscope: How AI can help minimise compliance risks
Dr Joe DiCapite, Vodori Director of Strategy, discusses why he believes a revolution in material review software is coming.
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Economics and risks of FDA’s Quality management maturity rating programme
Ensuring that pharmaceutical manufacturers not only adhere to current good manufacturing processes but go beyond to embrace a culture of quality has far-reaching consequences for the industry, the health care community and consumers. A focus on quality across many sectors of the economy has demonstrated direct economic benefits accruing to…
video
On-demand webinar: Effective contamination control strategy
Discover the significance of accurate microbial identifications in building an effective contamination control strategy to keep up with the latest regulatory requirements.
whitepaper
Guide: Rapid microbial detection methods
Plate counting falls short in reducing the risk of contamination during pharmaceutical production. Learn more about rapid microbiological methods.
webinar
Validation and implementation of a novel automated PCR technology for mycoplasma testing
22 September 2022 | By bioMérieux
This on-demand webinar presents the regulatory submission strategy for implementation and validation of a new PCR-based technology for mycoplasma testing of different products.
whitepaper
Whitepaper: PAT leads the way in the adoption of continuous manufacturing processes
Martin Gadsby, CEO & Director at Optimal Industrial Technologies and Flavio Belvedere, Co-Founder of ABCS Srl, look at the benefits of PAT and the aspects to consider when deploying it.
whitepaper
Whitepaper: Building a tomorrow-ready lab with CaliberLIMS
Achieve digital lab transformation by becoming future ready with the 100% paperless lab requisites. Check the wish list for a better tomorrow lab.
whitepaper
Whitepaper: Annual PQR: A thing of the past
Anytime PQR is the new way of generating APQR by automating the reports anytime in 3 easy steps. Now make the entire process system driven with CaliberAPQR.
podcasts
EPR Podcast Episode 13 – QC spectroscopy compliance – Garry Wright and Julia Griffen, Agilent
Discover the common compliance concerns encountered when using spectroscopy instruments for QC, as well as how to rectify them in this episode with Agilent Technologies.
news
Common pharma compliance concerns cited by FDA warning letters
A review of the last decade of FDA warning letters finds quality control operations, manufacturing process validation, and data record and integrity are the key points of scrutiny.
