Good Practice Guide: Compliant GxP Computerised Systems
The ISPE GAMP 5 Second Edition provides a risk-based approach for the validation of computerised systems used in pharmaceutical manufacturing. Updates the original 2008 guide to reflect cloud computing, modern software development, and agile methodologies.
All GxP computerised systems in regulated industries: process control systems, laboratory instruments, QMS, LIMS, DCS, MES, and clinical data systems.
- 01Software category classification: Category 1 (infrastructure), 3 (non-configured), 4 (configured), 5 (bespoke)
- 02Risk-based validation approach — validation effort proportional to risk and complexity
- 03Supplier assessment commensurate with system category and risk
- 04Data integrity by design — ALCOA+ principles built into system specification
- 05Validation lifecycle: specification → testing → operation → review → retirement
Second Edition April 2022. Major updates: cloud computing guidance, agile methodology, modern software development, updated category definitions. First Edition 2008 is obsolete — transition to 2022 edition.
ISPE GAMP 5 (2022): frequently asked questions
Quick answers to common questions about ISPE GAMP 5 (2022).
What is ISPE GAMP 5 (2022)?
ISPE GAMP 5 (2022) — Good Practice Guide: Compliant GxP Computerised Systems — is a guidance issued by the International Society for Pharmaceutical Engineering. The ISPE GAMP 5 Second Edition provides a risk-based approach for the validation of computerised systems used in pharmaceutical manufacturing. Updates the original 2008 guide to reflect cloud computing, modern software development, and agile methodologies.
Who does ISPE GAMP 5 (2022) apply to?
All GxP computerised systems in regulated industries: process control systems, laboratory instruments, QMS, LIMS, DCS, MES, and clinical data systems.
What are the key requirements of ISPE GAMP 5 (2022)?
ISPE GAMP 5 (2022) requires, among other things: Software category classification: Category 1 (infrastructure), 3 (non-configured), 4 (configured), 5 (bespoke); Risk-based validation approach — validation effort proportional to risk and complexity; Supplier assessment commensurate with system category and risk; Data integrity by design — ALCOA+ principles built into system specification.
When was ISPE GAMP 5 (2022) last updated?
The current version of ISPE GAMP 5 (2022) dates from April 2022. Second Edition April 2022. Major updates: cloud computing guidance, agile methodology, modern software development, updated category definitions. First Edition 2008 is obsolete — transition to 2022 edition.
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When ISPE GAMP 5 (2022) — or any GxP requirement — is revised, recalled against, or clarified by new guidance, the Weekly GxP Briefing surfaces it. Free, one email a week.