What is the difference between Site master file and Master formula record?
Site master file is a document prepared by the manufacturer containing specific and actual good manufacturing practice (GMP) information about the production and/or control of pharmaceutical manufacturing operations carried out at the named site and any closely integrated operations at adjacent and nearby buildings. If only part of a pharmaceutical operation is carried out on the site, the SMF need describe only those operations, e.g. analysis, packaging.
Master formula record is a document or set of documents specifying the starting materials with their quantities and the packaging materials, together with a description of the procedures and precautions required to produce a specified quantity of a finished product as well as the processing instructions, including the in-process controls.
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