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Case study: GC-MS for cGMP nitrosamine testing
What pharmaceutical QA/QC laboratories need to know to overcome the challenges of nitrosamine impurities in drugs for cGMP testing.
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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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Future proofing risk assessment: preventing the next nitrosamine incident
The valsartan nitrosamine contamination issue was probably the most significant quality issue to hit the pharmaceutical industry in a decade. Here, Dave Elder outlines how agencies and manufacturers are dealing with the problem and indicates the knowledge gaps that might be concealing future complications.
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Technical bulletin: Nitrosamine control: understanding the new FDA and EMA regulations
This technical bulletin discusses major regulatory updates, introduced by the FDA and EMA, regarding nitrosamines and SGS proposed risk assessment method for compliance.
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Whitepaper: Sterile formulation strategies to shorten timelines
This whitepaper reveals strategies to create simple, stable formulations for your sterile injectable, a solid foundation for your product’s lifecycle.
news
Regulators recommend remote inspections for use post-pandemic
A review of remote regulatory inspections has recommended that they be used in conjunction with on-site visits to enable GxP oversight post-pandemic.
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Brochure: Simplify your compliance process
Find out how to simplify your compliance process and connect data from multiple stakeholders with SAP Advanced Track and Trace for Pharmaceuticals.
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Whitepaper: USP method modernisation
How ion chromatography can help to modernise and simplify out-dated USP methods for ion analysis.
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Whitepaper: Sterility testing – difficult products
This whitepaper considers sterility testing to support pharmacopoeial monographs with an emphasis on products that are difficult to test or validate.
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On-demand webinar: AstraZeneca’s fully automated nitrosamine analysis
This on-demand webinar details a qualified automated approach to nitrosamine testing in products, which simultaneously prepares samples for LC-MS and GC-MS.
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Whitepaper: Implementing 21 CFR Part 11 in epMotion® software
Electronic records and electronic signatures in the regulated environment of the pharmaceutical and medical device industries.
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Whitepaper: Accelerate biologics development via innovation
This whitepaper provides a roadmap for assessing and selecting the right partner to get promising biological therapies to patients quickly.
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Case study: Better, faster method development at Janssen
Learn how method development software helped Janssen Pharmaceuticals reduce method development time by 80 percent with a 25-fold increase in method quality.
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Case study: Amino acid analysis for EP compliance
An ion chromatography solution, devoted to fast turnaround of raw material testing for amino acids per the EP monographs.
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Press release: Freeze drying: New Telstar Usifroid platform for retrofitting & maintenance
Telstar launches Usifroid global service platform for retrofitting & maintenance of freeze-dryers. To optimise and extend the life cycle of freeze-drying equipment from any brand or model.
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Whitepaper: Drug repurposing strategies to shorten timelines
This whitepaper explores drug repurposing, where known clinical candidates or commercially approved molecules are evaluated for new targets and indications.
