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STANDARD OPERATING PROCEDURES - PharmTech

Concerns, problems,and difficulties are those that FDAinspectors look outfor. Then we makesure you know howto address thoseissues properly (seethe Prepare for anFDA Inspection sidebar).Much of aninspection focuseson a company squality systems. Bydefinition, a qualitysystemis a programthat addresses theneeds and elementsof a specific part of amanufacturing oper-ation. A trainingprogram, for exam-ple, is a qualitysystem a qualitysystem that definesin detail how thecompany will ensurethat its employees have the proper knowledge tocarry out their and biotechnology companiestypically determine how they are going toclassify their quality systems. Quality systemstypically include STANDARD OPERATING PROCEDURES (SOPs), monitoring programs, change controlpolicies, validation programs, training, deviationand investigation programs, and consistent docu-mentation survival guide, therefore, also begins byfocusing on quality systems: on determiningthose quality systems needed and in place, onascertaining how practical particular qualitysystems are, and on checking how well thosequality systems have been implemented andfollowed.

typically include standard operating procedures (SOPs), monitoring programs, change control policies, validation programs, training, deviation and investigation programs, and consistent docu-mentation practices. Our survival guide, therefore, also begins …

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