Salt formation is important in pharmaceutical and biopharmaceutical drug development to improve physicochemical properties of the drug. Approximately half of all drugs are formulated and administered as salts. A broad selection of inorganic and organic ions can be used as pharmaceutical counterions.
Pharmaceutical QA/QC Information
Your pharmaceutical quality is assured
Modern advances in pharmacology have resulted in increased life expectancy and reduced suffering of patients fighting disease. It is the frail and vulnerable that have come to rely on modern medicines. Consequently, it is paramount that prescribed drugs have the desired therapeutic efficacy, without fear of harmful side effects from impurities. For healthcare systems to provide quality care, prescription medicines must meet regulatory quality assurance standards.
Increasingly pharmaceutical manufacturers are looking to data management and informatics solutions to ensure that critical information is not only accessible when demanded, but ready to provide decision support to the highest levels of the organization.
Pharmaceutical QA/QC information subtopics
Extractable and Leachable compounds can migrate from polymeric materials used in container closure, production, and packaging systems for pharmaceuticals and biopharmaceuticals. A container closure system should not release chemicals that can accumulate in the drug product in quantities sufficient to present a risk of toxicity or affect its stability or efficacy.
Organic synthesis or cell culture (in the case of biotherapeutics) often leads to less than 100% production. Consequently, a range of impurities are made together with any medicine. In addition, impurities can come from anything within the production or packaging chain that the medicine comes into contact with.
Residual solvents in pharmaceuticals are volatile organic compounds used or created during the manufacture of drugs and pharmaceutical additives. The U.S. Pharmacopeia (USP) general chapters <467> Residual Solvents were created based on the analytical methods specified in the EP (European Pharmacopoeia) to ensure pharmaceuticals are free from toxicologically significant levels of volatile organic compounds.
Elemental impurities in pharmaceutical formulations can come from catalysts, formulation ingredients and from process vessels. They can interfere with drug effiicacy or elicit a direct toxic effect on the patient.
Understand necessary steps to have a successful, cost-effective software validation, including challenges and pitfalls, as well as potential solutions.
James O. Westgard presents a practical approach to implementing your Individual QC Plan.