Meaning ((hot)) | Gamp

| Principle | Meaning | |-----------|---------| | | The ultimate goal of all validation activities. | | Risk-Based Approach | More validation effort is applied to high-risk systems (e.g., sterilization control) than low-risk ones (e.g., warehouse lighting). | | Lifecycle Validation | Validation is not a one-time event but continues from concept to retirement (V-Model lifecycle). | | Traceability | Every requirement must be traceable to a test and to an operational function. | | Supplier Involvement | Leverage supplier documentation and expertise rather than re-testing everything internally. | 5. The GAMP 5 "SoftwARe Categorization" (Risk-Based) A key practical output of GAMP is the 5-category system for software, which determines the validation effort required.

An Investigative Report on the Meaning and Application of GAMP (Good Automated Manufacturing Practice) gamp meaning