A Review on Eight System Inspection Model
The FDA's Drug Manufacturing Inspection Compliance Program, which constitutes instructions to FDA personnel for conducting inspections, is a systems-based approach for inspections and is very consistent with the robust quality systems model presented in this guidance. The diagram below shows the relationship among the six systems: the quality system and the five manufacturing systems. The quality system provides the foundation for the manufacturing systems that are linked and function within it. The quality systems model described in this guidance does not treat the five manufacturing systems as discrete entities, but instead integrates them into appropriate sections of the model. Those familiar with the six-system inspection approach will see organizational differences in this guidance; however, the inter-relationship. Generally, the term quality unit is used in this guidance. However, quality control unit is used when directly quoting parts. United States Food and Drug Administration (USFDA) propose Six System Inspection Model for the audit of pharmaceutical organization for minimization of regulatory submission. Author studied this system, then added and modified this to Eight System Inspection Model to make this more useful and user friendly for the pharmaceutical organization which wants to go for USFDA or other international audits. While doing this author added two additional systems (Management/Regulatory) and four additional points (Validation, HVAC System Validation, Water and Steam System Validation and Vendor Certification).
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