whitepaper
Whitepaper: GMP Cleanroom Environmental Monitoring
This whitepaper from Beckman Coulter explores GMP cleanroom routine environmental monitoring and data integrity.
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QA/QC
news
Report calls for development of new cannabis testing technologies
According to research, the rise in demand for high-quality cannabis will also drive growth in the cannabis testing market, where new technologies are needed to overcome current limitations.
news
New MET ONE 3400+ air particle counter automates routine environmental monitoring for GMP cleanroom compliance
Integrated electronic SOPs and maps are “all in the box” to help reduce errors.
whitepaper
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?
whitepaper
Brochure: MET ONE 3400+ Air Particle Counter
The new MET ONE 3400+ Series PortableAirborne Particle Counter automates environmental monitoring for GMP cleanroom compliance.
article
FMD alerts in 2020 – where we are a year into legislation
Over a year since the EU FMD came into force, false alerts remain a problem preventing the realisation of the full benefits of the directive. Grant Courtney examines the reasons behind these alerts occurring and looks at the action stakeholders must now take.
news
EMA issues opinion on nitrosamines in medicines
The agency’s opinion will require companies to take measures to reduce nitrosamine impurities in medicines and carry out and action the results of risk assessments.
news
FDA approves new heart rhythm devices featuring Bluetooth connectivity and continuous remote monitoring
Abbott’s Gallant™ implantable cardioverter defibrillator (ICD) and cardiac resynchronisation therapy defibrillator (CRT-D) devices are given approval.
news
European Pharmacopoeia publishes new chapter regarding BET testing
The new chapter describes a method for bacterial endotoxins (BET) testing using recombinant factor C (rFC) instead of limulus amoebocyte lysate (LAL).
video
On-demand webinar: Outsourcing selected areas of the quality system
Former MHRA inspector Rachel Carmichael discusses outsourcing areas of your quality system including what would drive this decision, aspects of the operation that can be supported and measures to facilitate the process
article
Comparison of health technology assessments and time to reimbursement for Orphan Drugs
This article delves into four health technology assessment agencies, analysing the opportunities and challenges for orphan drugs in France, Germany, England and Scotland.
news
NICE does not recommend Novartis’ siponimod for secondary progressive MS
NICE has decided to not recommend Mayzent (siponimod) for use on the NHS as a secondary progressive multiple sclerosis treatment because its clinical trial did not directly compare it to interferon beta-1b.
whitepaper
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.
whitepaper
Infographic: Benefits and applications of Ozone Technology
Learn the benefits of Ozonia MEMBREL electrolytic ozone technology in ultrapure water disinfection applications.
article
How implantable systems and microparticle depot injections are meeting the needs of long-acting drug delivery
Implantable systems and microparticle depots are used in many areas of drug delivery to release medicines at a controlled rate within the body. The use of these long-acting dosage forms eliminates the need for frequent administrations via traditional routes of administration, which ensures patient compliance and results in improved outcomes.…
