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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.
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.
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.
Species-level microbial identification (ID) is a growing requirement under good manufacturing practice (GMP) to ensure patient safety.
High-potency drugs present numerous opportunities for improved drug selectivity, efficacy and safety profiles.
Extractables studies for chromatography resins based on the adapted requirements of the USP support risk evaluation for chromatography steps.
Introduction to BioPhorum (BPOG) raw materials risk assessments tool and an overview on risk assessment regulations for raw materials.
21 October 2020 | By Lonza Pharma & Biotech
Watch our on-demand webinar to learn about liquid-filled hard capsule technology has a proven record for addressing complex active pharmaceutical ingredient (API) formulation challenges, including bioavailability enhancement.
The identification of N-nitrosodimethylamine (NDMA) in an active pharmaceutical ingredient (API) in 2018 not only led to regulatory warnings and product recalls, but wider recognition that pharmaceutical manufacturers should adopt a proactive approach to risk assessment and mitigation in relation to genotoxic contaminants.
Specialising in chromogenic and turbidimetric reagent technologies, ACC has been a global leader in endotoxin and (1→3)-ß-D-glucans detection products and services for more than 45 years.
Data integrity (DI) continues to trend as a hot topic for pharmaceutical manufacturers, despite the fact it is an expectation that has been present for years.
5 October 2020 | By Merck KGaA
This on-demand webinar provides an overview of a holistic approach to achieve compliance with good manufacturing practice (GMP) requirements for environmental monitoring (EM) in aseptic manufacturing areas, such as ISO 5 cleanrooms in traditional setup, RABS or isolators.
