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GMP INSPECTIONS OF DRUG SUBSTANCE MANUFACTURERS

 

The Pre-approval Inspection Program and a change in Compliance philosophy has generated considerable discussion in the pharmaceutical industry. With the Pre-Approval Program, the Field is now a participant in the Review and Approval Process. Up to this time, much of the Fieldwork in the Pre-Approval Program has been directed to the dosage form manufacturer. However, it is anticipated that this may change

 

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