Abstract
Good Manufacturing Practice (GMP) is described in one form or another in many countries for the purpose of guiding the manufacture, production and distribution of medical products and pharmaceuticals. The common theme contained in all of these documents is the description of what can best be called a system of documentation and records. The principles, hierarchy, and applications of such a documented quality system will be described.
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Nevalainen, D.E. (1994). Documentation and Record Keeping: The Key to Compliance. In: Sibinga, C.T.S., Das, P.C., Heiniger, H.J. (eds) Good Manufacturing Practice in Transfusion Medicine. Developments in Hematology and Immunology, vol 29. Springer, Boston, MA. https://doi.org/10.1007/978-1-4615-2608-7_16
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DOI: https://doi.org/10.1007/978-1-4615-2608-7_16
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