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Your endotoxin experts
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.
List view / Grid view
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.
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Data integrity: an opportunity to improve classical microbiological methods
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.
webinar
Roadmap to compliance in environmental monitoring
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.
whitepaper
Whitepaper: How will COVID-19 accelerate vaccine development?
Watson-Marlow Fluid Technology Group discusses how the biopharma community is coming together to solve the global vaccine development challenge.
whitepaper
Whitepaper: Characterising insulin as a biopharmaceutical using Analytical Ultracentrifugation
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.
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Release of sterile medicinal products – looking at the focal points
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.
product
Product hub: New MET ONE 3400+ air particle counter
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.
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Expert view: Our air samplers are designed to perfectly match customer needs
A discussion between experts Roger Haas, Head of Environmental Monitoring Franchise at Merck KGaA, Darmstadt, Germany, and Ronny Zingre, CEO of MBV AG.
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Expert view: Realising real-time TOC testing and Pharma 4.0 improvements in pharmaceutical grade water systems
This expert view from SUEZ discusses how total organic carbon (TOC) and conductivity monitoring are crucial aspects of purified water system quality and control.
news
FDA releases guidance on bioavailability and bioequivalence study samples
The FDA has released guidance on its compliance policy on reserve samples used in bioavailability and bioequivalence studies.
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Video: JRS Pharma – The global MCC manufacturing network
Discover JRS PHARMA's industry leading manufacturing network for Microcrystalline Cellulose.
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Brochure: GMP Manufacturing
Quality control testing instrumentation solutions for GMP manufacturing. From raw materials QC through production QC and final product QC.
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Whitepaper: GMP Cleanrooms Classification
This whitepaper from Beckman Coulter discusses GMP Cleanrooms Classification and Routine Environmental Monitoring.
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Whitepaper: GMP Cleanroom Environmental Monitoring
This whitepaper from Beckman Coulter explores GMP cleanroom routine environmental monitoring and data integrity.
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Infographic: Maintaining data integrity
Maintaining Data Integrity. Did you know that lack of data integrity has been a top reason for FDA Drug GMP warning letters?
