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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.
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
Join our live webinar on 24 November 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
Join us on 18 November where we will provide 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.
Watson-Marlow Fluid Technology Group discusses how the biopharma community is coming together to solve the global vaccine development challenge.
AUC was used to probe the effect of insulin concentration and the zinc chelating agent EDTA on monomer, dimer, and hexamer formation of USP Human Insulin Standard.
There are numerous risks and regulatory requirements that must be considered to ensure appropriate contamination control of sterile medicinal products. Tim Sandle discusses the complexities of sterility assurance and provides guidance for manufacturers to ensure that appropriate risk management processes are in place.
Beckman Coulter Life Sciences has introduced the MET ONE 3400+ portable air particle counter to help GMP cleanroom users simplify their routine environmental monitoring and improve data integrity.
A discussion between experts Roger Haas, Head of Environmental Monitoring Franchise at Merck KGaA, Darmstadt, Germany, and Ronny Zingre, CEO of MBV AG.
