Whitepaper: HPLC in pharmaceutical analysis
Learn why water purity matters in this essential guide to HPLC in pharma analysis. Find out how to deal with water-related issues in drug manufacture, analysis and QC.
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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.
Learn why water purity matters in this essential guide to HPLC in pharma analysis. Find out how to deal with water-related issues in drug manufacture, analysis and QC.
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Our customised microbial solutions ensure your cleanroom is compliant and free of contamination to manufacture safe and effective products.
Get the most detailed information about UDI – requirements, implementation and benefits. Everything that supply chain participants need to know!
This whitepaper gives an understanding of the evolving regulatory guidelines for cell and gene therapies, in order to bring them to market faster.
What pharmaceutical QA/QC laboratories need to know to overcome the challenges of nitrosamine impurities in drugs for cGMP testing.
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.
This technical bulletin discusses major regulatory updates, introduced by the FDA and EMA, regarding nitrosamines and SGS proposed risk assessment method for compliance.
This whitepaper reveals strategies to create simple, stable formulations for your sterile injectable, a solid foundation for your product’s lifecycle.
A review of remote regulatory inspections has recommended that they be used in conjunction with on-site visits to enable GxP oversight post-pandemic.
Find out how to simplify your compliance process and connect data from multiple stakeholders with SAP Advanced Track and Trace for Pharmaceuticals.
How ion chromatography can help to modernise and simplify out-dated USP methods for ion analysis.
This whitepaper considers sterility testing to support pharmacopoeial monographs with an emphasis on products that are difficult to test or validate.
This on-demand webinar details a qualified automated approach to nitrosamine testing in products, which simultaneously prepares samples for LC-MS and GC-MS.
Electronic records and electronic signatures in the regulated environment of the pharmaceutical and medical device industries.