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Zdrowie i gospodarka · 15.04.2016

Data Integrity and Compliance With Current Good Manufacturing Practice; Draft Guidance for Industry; Availability

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Data Integrity and Compliance With CGMP.'' The purpose of the draft guidance is to clarify the role of data integrity in current good manufacturing practice (CGMP) for drugs. The draft guidance is in response to an increase in CGMP violations involving data integrity observed in recent CGMP inspections. When finalized, the draft guidance is intended to provide the Agency's current thinking on the creation and handling of data in accordance with CGMP requirements.

Source: Federal Register — Food and Drug AdministrationOpen original release →