Whitepapers/App Notes/Posters
Whitepaper: Turbocharging Raman measurements
This whitepaper describes the proprietary HyperFlux™ optical spectrometer designs developed by Tornado Spectral Systems.
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Good Manufacturing Practice (GMP)
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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.
video
On-demand webinar: Best practices for cleaning and disinfection
This on-demand webinar focuses on the importance of cleaning & disinfection, covering legal requirements & the global guidelines for disinfection in cleanrooms.
Whitepapers/App Notes/Posters
Factsheet: Total Organic Carbon (TOC) back to basics
Total Organic Carbon (TOC) analysis is used to comply with compendia water testing requirements. Read this document to learn the basics on TOC.
article
QA/QC & Analytical Techniques In-Depth Focus 2020
In this in-depth focus find out why deep ultra-violet (DUV) handheld devices could replace current onsite cleaning verification applications and how Raman spectroscopy could be used to improve COVID-19 detection.
Whitepapers/App Notes/Posters
Fact sheet: 5 Secrets to a successful cleaning validation program
Here are five ways to ensure a successful and compliant cleaning validation program.
article
Regulatory response to the COVID-19 pandemic
Dr Ash Ramzan, founder and principal consultant at Woodley BioReg, discusses how the COVID-19 pandemic has forced regulatory processes to adapt, focusing on the regulatory flexibilities introduced by the UK’s MHRA.
Whitepapers/App Notes/Posters
Fact sheet: CFS 1200® capsule filling and sealing machine
At Lonza, we have developed our CFS 1200® capsule filling and sealing machine as part of our Lonza Engine™ portfolio. Used with our Capsugel® capsules, pharmacies can automate this process to optimise operations and accuracy. This fact sheet will introduce you to its handling and sealing capabilities, key benefits, performance…
Whitepapers/App Notes/Posters
Interactive PDF: Risk mitigation and quality requirements interactive tool
Risk mitigation interactive tool to guide you through the challenges and quality requirements of your bio-manufacturing process.
Whitepapers/App Notes/Posters
Whitepaper: BPOG extractables data in single-use systems adoption
An overview on the role of BPOG extractables data in the effective adoption of single-use systems in biomanufacturing
webinar
How to master raw material ID testing in 2021
11 November 2020 | By Thermo Fisher Scientific
In this on-demand webinar we explore the evolving role of handheld and portable instruments to drive quality improvements and manufacturing success in 2021.
Whitepapers/App Notes/Posters
Fact sheet: TOC monitoring efficiency quiz
Take our 10-question quiz to find out how efficient your Total Organic Carbon (TOC) monitoring programme is for your applications.
news
News: Microbial solutions product portfolio updates
Charles River provides essential products and services to help pharmaceutical and biotechnology companies, government agencies and leading academic institutions around the globe accelerate their research and drug development efforts.
article
Expert view: Mitigating risk with modern microbial identifications
Species-level microbial identification (ID) is a growing requirement under good manufacturing practice (GMP) to ensure patient safety.
article
High-potency drugs – challenges and factors
High-potency drugs present numerous opportunities for improved drug selectivity, efficacy and safety profiles.
video
On-demand webinar: Extractables profiles for chromatography resins
Extractables studies for chromatography resins based on the adapted requirements of the USP support risk evaluation for chromatography steps.