Whitepapers/App Notes/Posters
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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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.
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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?
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Brochure: MET ONE 3400+ Air Particle Counter
The new MET ONE 3400+ Series PortableAirborne Particle Counter automates environmental monitoring for GMPcleanroom compliance.
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CureVac recieves €75 million loan for vaccine development and manufacturing expansion
The European Investment Bank (EIB) will provide three €25 million instalments to support CureVac’s vaccine development and expansion to mRNA production facilities.
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Application note: Ozonia Ozone Technology for ultrapure water disinfection
Learn why Ozonia MEMBREL electrolytic ozone technology is the ultimate solution for ultrapure water disinfection applications.
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Infographic: Benefits and applications of Ozone Technology
Learn the benefits of Ozonia MEMBREL electrolytic ozone technology in ultrapure water disinfection applications.
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Application note: Pharmaceutical analysis using UV-Vis: compliance with USP Chapter <857> and European pharmacopoeia (Ph. Eur. Chapter 2.2.25)
USP general chapter and Ph. Eur. chapter 2.2.25 guide instrument operational qualification protocols for UV-Vis spectroscopy. This technical note demonstrates how to ensure qualification as per global pharmacopoeias' requirements.
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bioBoaVista manufactures customised media for COVID nasal diagnostic tests using the Flexicon PF7
bioBoaVista showcases its viral transport medium, that can stabilise samples, for efficient nasal tests for the diagnosis of COVID-19.
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How confident are you that your data is complete, secure and accurate?
Reliable data integrity tools to take control of your equipment and data.
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Application note: Nitrosamines by GC-MS in Valsartan
Determination of nitrosamines including gentoxic NDMA analysed by GC-MS in Valsartan using direct injection and headspace methods, below required LOD.
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Application note: Organic acids in solutions by IC-MS
A simple, sensitive and selective direct method using IC coupled to a single quadrupole MS to analyse organic acids in drug solutions.
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Application note: Nitrosamines in drug product by HRAM-LCMS
HPLC with HRAM MS method for the determination and quantitation of nitrosamine impurities in drug products consistent with FDA requirements.
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Global regulatory authorities COVID-19 policy and regulations meeting
Global pharma regulators met to discuss measures to ensure supply continuity, flexible regulatory policies and their expectations for COVID-19 clinical trials.