Regulations, Validation and the Future is the third volume in the Pharmaceutical Dosage Forms- Parenteral Medications three-volume set. The book presents an in-depth discussion of regulatory requirements, quality assurance, risk assessment and mitigation, and extractables/leachables. It explores parenteral administrations devices, injection site pain assessment, parenteral product specifications, and stability testing. It also discusses and the future of parenteral product manufacturing and siRNA delivery systems. New chapters cover recent developments in the areas of visual inspection, quality by design (QbD), process analytical technology (PAT) and rapid microbiological methods (RMM ), as well as validation of drug product manufacturing process.
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