Global Regulations for Equipment Qualification and Validation of Processes in the Pharma Manufacturing

The various regulatory agencies have expectations that pharmaceutical manufacturers will demonstrate control over their manufacturing equipment. The FDA's findings of deficiencies concerning equipment validation indicate the agencies expect definitive evidence that the equipment qualification and validation schedules of a facility will satisfactorily control their manufacturing processes. Examples of FDA form 483 findings for equipment qualification and validation indicate deficiencies in many of these studies.

Topics: Equipment Qualification, DQ, IQ, OQ, PQ, Validation Processes, Change Control, Validation Master Plan (VMP), SOPs, QMS, Risk Analysis, FDA Warning Letters, case Study, FDA Compliance Seminar