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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.
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…
A new project funded by Swedish innovation agency Vinnova, will help develop an AI-based quality control method for ATMP manufacturing.
Learn how a US influenza vaccine manufacturer concerned with intermittent positive plate counts used rapid microbial monitoring to save time and money.
Dr Joe DiCapite, Vodori Director of Strategy, discusses why he believes a revolution in material review software is coming.
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…
Discover the significance of accurate microbial identifications in building an effective contamination control strategy to keep up with the latest regulatory requirements.
Plate counting falls short in reducing the risk of contamination during pharmaceutical production. Learn more about rapid microbiological methods.
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.
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.
Achieve digital lab transformation by becoming future ready with the 100% paperless lab requisites. Check the wish list for a better tomorrow lab.
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.
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.
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.
As biopharmaceuticals become an increasingly important part of the drug development pipeline and market, EPR discusses key trends in the outsourcing of their manufacturing.
Here AMR Industry Alliance representatives Melissa Gong Mitchell and Steve Brooks discuss how the Alliance is mobilising the life sciences sector in combatting antimicrobial resistance (AMR). They present the newly established antibiotics manufacturing standard that aims to minimise pharma’s contribution to AMR in the environment, considering the critical considerations and…
