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Unique emphasis should be put around the administration from the constitutive excipients with the formulated active material. Specs must be defined for excipients Based on GMP Section I., 4.14 as well as the monographs of the ecu Pharmacopoeia needs to be used. The acceptance, servicing and audit of excipient suppliers need to be according to quali
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All personnel that enter the aseptic processing area, such as people who only enter periodically and outside staff permitted by Good quality, shall be skilled via a official education software.Treatments for interpreting Environmental Monitoring (EM) media plates from powder filling operations shall contain conditions for discrimination of microbia
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