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During the operational life of a GxP system regulators usually focus on the integrity, consistency, and completeness of controls required to maintain compliance. This Guide highlights the importance of the operation phase of the system lifecycle, whe...
INFORMATION SYSTEMS
GOOD AUTOMATED MANUFACTURING PRACTICE (GAMP®)
...
INFORMATION SYSTEMS
GOOD AUTOMATED MANUFACTURING PRACTICE (GAMP®)

The Guide provides an overview of FDA regulations and guidance necessary for conducting safe compounding to help pharmacies understand the requirements of FD&C Act Section 503A. In addition, the ISPE Guide outlines the authority of State Boards of...