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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.
9 February 2021 | By Sartorius
During this on-demand webinar we discuss how to achieve data integrity and give real examples from the US Food and Drug Administration (FDA) warning letters about the most frequent and typical violations.
Strategies for upstream process intensification can be leveraged for cell line development, the seed train, production and cell culture media formulation.
Lyophilised drug product containers and administration devices consist of the primary packaging, the reconstitution solution container, and the drug administration set.
G-CON cleanroom PODs. Reliable, flexible prefabricated cleanrooms for the biopharmaceutical industry. On budget and on time.
This whitepaper describes the proprietary HyperFlux™ optical spectrometer designs developed by Tornado Spectral Systems.
This on-demand webinar focuses on the importance of cleaning and disinfection, covering legal requirements and the global guidelines for disinfection in cleanrooms.
Total Organic Carbon (TOC) analysis is used to comply with compendia water testing requirements. Read this document to learn the basics on TOC.
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.
Here are five ways to ensure a successful and compliant cleaning validation program.
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.
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…
Risk mitigation interactive tool to guide you through the challenges and quality requirements of your bio-manufacturing process.
An overview on the role of BPOG extractables data in the effective adoption of single-use systems in biomanufacturing
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.
Take our 10-question quiz to find out how efficient your Total Organic Carbon (TOC) monitoring programme is for your applications.
