What is the current GAMP 5 edition?
GAMP 5 second edition (2022) is the current edition.
GAMP 5 Risk-Based Validation
GAMP 5 (ISPE) risk-based validation services for pharmaceutical GxP systems. The engagement covers the GAMP 5 categorization, the risk assessment, the validation strategy, and the implementation support.
GAMP 5 categories
GAMP 5 defines categories based on the system type: Category 1 (infrastructure software), Category 3 (non-configured COTS), Category 4 (configured COTS), and Category 5 (custom-developed).
Risk assessment
The GAMP 5 risk assessment identifies the GxP impact, the patient impact, the product quality impact, and the data integrity impact.
Validation strategy
The validation strategy defines the URS, FDS, IQ, OQ, PQ, the change control, the periodic review, and the validation maintenance per the GAMP 5 category and the risk assessment.
How to use this page
Use this GAMP 5 Risk-Based Validation page as a planning checkpoint before vendor selection, architecture review, validation scoping or implementation sequencing. The strongest next step is to compare the guidance with your current SOPs, system inventory, batch records, data flows and QA review routines so the discussion starts from evidence instead of assumptions.
Evidence to prepare
For GAMP 5 Risk-Based Validation, prepare the records, owners, risks and decision criteria linked to gamp 5 categories, risk assessment, validation strategy. Useful evidence includes current process maps, interface lists, audit trail expectations, exception workflows, data retention rules and the business reason for changing the current operating model.
Frequently asked questions
Is GAMP 5 a regulation?
No, GAMP 5 is an ISPE guidance document. It is widely adopted as a best practice for risk-based validation.