Abstract
In this whitepaper, the Manufacturing Technical Committee of the Product Quality Research Institute provides information on the common, best practices in use today in the development of high-quality chemistry, manufacturing and controls documentation. Important topics reviewed include International Conference on Harmonization, in vitro-in vivo correlation considerations, quality-by-design approaches, process analytical technologies and current scale-up, and process control and validation practices. It is the hope and intent that this whitepaper will engender expanded dialog on this important subject by the pharmaceutical industry and its regulatory bodies.
MeSH terms
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Animals
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Benchmarking / standards*
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Chemistry, Pharmaceutical / standards
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Delayed-Action Preparations / standards
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Drug Approval
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Drug Industry / methods
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Drug Industry / standards*
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Excipients / chemistry
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Excipients / standards
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Humans
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Pharmaceutical Preparations / administration & dosage
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Pharmaceutical Preparations / chemistry
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Pharmaceutical Preparations / standards*
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Pharmacokinetics
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Quality Control
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Risk Assessment
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Solubility
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Technology, Pharmaceutical / methods
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Technology, Pharmaceutical / standards*
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Toxicology / standards
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Vereinigte Staaten
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United States Food and Drug Administration
Substances
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Delayed-Action Preparations
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Excipients
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Pharmaceutical Preparations