There was a tendency in the GAMP 4 era to test "everything." If a system had 500 functions, a validation protocol might attempt to test all 500, regardless of whether they were used.
The following are the key differences between GAMP 4 and GAMP 5: difference between gamp 4 and gamp 5
| Parameter | GAMP 4 Approach (Old) | GAMP 5 Approach (New) | Feature Output | |-----------|------------------------|------------------------|------------------| | | After category assignment | Before category assignment | Prompts user: “Assess patient/product impact first” | | System categorization | 4 categories (1,2,3,4,5) – incl. “firmware” | 4 categories (1,3,4,5) – no “firmware” | Flags “Category 2” as obsolete; recommends re-categorization | | Supplier involvement | Limited to specs review | Critical throughout lifecycle | Generates Supplier Assessment Form with GAMP 5 criteria | | Documentation volume | Prescriptive, one-size-fits-all | Scalable, effort based on risk | Creates a Lean Validation Plan (cuts V-model docs by ~40%) | | Testing approach | Full IQ/OQ/PQ always | Critical thinking + USP <1058> for lab systems | Recommends “Verify only high-risk functions” with justification template | There was a tendency in the GAMP 4 era to test "everything
GAMP 5 aligned itself with the major regulatory shifts of the mid-2000s, specifically the FDA’s guidance on Guidance for Industry: Quality Systems Approach to Pharmaceutical cGMP Regulations and ICH Q9 (Quality Risk Management). GAMP 5 asserts that validation efforts should not be uniform. Instead, they should be proportional to the risk the system poses to patient safety, product quality, and data integrity. The philosophy moved from "compliance by volume" to "compliance by critical thinking." GAMP 5 asserts that validation efforts should not be uniform
| Feature | GAMP 4 (2001) | GAMP 5 (2008/2022) | | :--- | :--- | :--- | | | Prescriptive, Process-driven. | Risk-based, Science-driven. | | Goal | Produce documentation to satisfy inspectors. | Protect patient safety and ensure product quality. | | Documentation | High volume, rigid structure. | Scalable, focus on value-add documents. | | Software Categories | 5 Categories (1-5). | 4 Categories (1, 3, 4, 5). | | Testing Strategy | Test all functions comprehensively. | Test based on risk and criticality. | | Vendor Relationship | Audit for document compliance. | Leverage supplier QMS and documentation. | | Data Integrity | Peripheral focus. | Central focus (especially in 2nd Ed). |