Abstract
Process validation is a requirement of the Current Good Manufacturing Practices Regulations for Finished Pharmaceuticals (United States) 21 CFR Parts 210 and 211, and of the Good Manufacturing Practice Regulations for Medical Devices, 21 CFR Part 820.
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References
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© 1987 Martinus Nijhoff Publishers, Dordrecht
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Bachmann, E. (1987). Process Validation. In: Kristensen, K., Nørbygaard, E. (eds) Safety and Efficacy of Radiopharmaceuticals 1987. Developments in Nuclear Medicine, vol 14. Springer, Dordrecht. https://doi.org/10.1007/978-94-009-3375-0_29
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DOI: https://doi.org/10.1007/978-94-009-3375-0_29
Publisher Name: Springer, Dordrecht
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