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.
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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.
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.
news
Trends in biopharma contract manufacturing 2022
As biopharmaceuticals become an increasingly important part of the drug development pipeline and market, EPR discusses key trends in the outsourcing of their manufacturing.
article
Tackling the silent pandemic: AMR Industry Alliance sets the Standard
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…
whitepaper
Whitepaper: Viral vectors as a gene delivery vehicle
Innovations in the use of viral vectors as a gene delivery vehicle are a key factor in the growth of the gene and cell therapy field.
video
On-demand webinar: The advantages of cartridge technology
Why do pharmaceutical manufacturers still believe older methods are reliable for quality testing when there’s superior technology available on the market?
video
Video: Free 10-minute pharma data integrity training
Ex-MHRA inspector and NSF expert, Rachel Carmichael, takes a high-level look at why Data Integrity matters in this online introduction training.
whitepaper
Whitepaper: Maintain product integrity in biologic clinical studies
Cold chain shipping challenges & root causes of common reference product sourcing problems.
news
What can we learn from contamination control failures?
Here EPR summarises the key points of Jeanne Moldenhauer’s article on what can be learned from warning letters and regulatory inspection observation reports.
