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• W2480516718 abstract "In this chapter, emphasis will be placed on the validation of solid dosage forms,from the early stages of product development through pilot scale-up and thecommercial manufacturing process. The objective is to present an overview andto discuss aspects of validation in terms of pharmaceutical unit operations; thatis, those individual technical operations that comprise the various steps involvedin product design and evaluation. The focus of the discussion will be on tablets,but consideration will also be given to hard gelatin capsules. The concept ofprocess validation from its beginnings in the early 1970s through the regulatoryaspects associated with current good manufacturing practice (CGMP) regulations and the application thereof to various analytical, quality assurance, pilotplant, production, and sterile produce considerations will be discussed elsewherein this book [1,2]." @default.
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• W2480516718 date "2003-03-27" @default.
• W2480516718 modified "2023-09-27" @default.
• W2480516718 title "Validation of Solid Dosage Forms" @default.
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• W2480516718 doi "https://doi.org/10.1201/9780203912119-9" @default.
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