Elements of a quality assurance program for pharmaceutical research & development 1 |
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| Authors: | Richard Kaplan Ph.D. |
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| Affiliation: | Regulatory Compliance , Centocor, Inc. , Malvern, Pennsylvania, 19355, USA |
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| Abstract: | The four major considerations for a pharmaceutical R&D quality program are discussed—protection of resources, compliance, documentation, fitness for use. Viewing R&D as an enterprise necessitates that R&D be seen as making products—data, analysis and interpretation. The applicability of the quality program to these products is discussed. |
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| Keywords: | quality assurance compliance data development |
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