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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.
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.
This whitepaper provides a roadmap for assessing and selecting the right partner to get promising biological therapies to patients quickly.
Learn how method development software helped Janssen Pharmaceuticals reduce method development time by 80 percent with a 25-fold increase in method quality.
An ion chromatography solution, devoted to fast turnaround of raw material testing for amino acids per the EP monographs.
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.
This whitepaper explores drug repurposing, where known clinical candidates or commercially approved molecules are evaluated for new targets and indications.
User guide for the calibration of pipettes and dispensers in the laboratory.
This webinar considers the fundamental importance of water system control within pharma processing and the best control and monitoring practices.
