GAMP 5 - Good Automated Manufacturing Practice
What is GAMP 5 - Good Automated Manufacturing Practice?
GAMP 5 (Good Automated Manufacturing Practice 5) is the INTERNATIONAL SOCIETY FOR PHARMACEUTICAL ENGINEERING (ISPE) flagship guide for Computerised Systems Validation in GxP-regulated environments (pharmaceutical + medical device + biotech + healthcare manufacturing + laboratories). Current edition GAMP 5 SECOND EDITION published July 2022 + supersedes the 2008 First Edition. It comprises 113 controls organised across 11 domains, and applies in International.
How GAMP 5 - Good Automated Manufacturing Practice maps to other frameworks
All 113 controls, each one mapped to the equivalent requirement in other standards, with the evidence that carries across and the mappings that were judged and rejected shown alongside. No account needed to look.
See the control mappings →The 11 domains GAMP 5 - Good Automated Manufacturing Practice groups its controls into
Frameworks that share controls with GAMP 5 - Good Automated Manufacturing Practice
Each of these has at least one control mapped to a control in GAMP 5 - Good Automated Manufacturing Practice. The number is how many GAMP 5 - Good Automated Manufacturing Practice controls are shared, counted from the mapping graph.
Annex 11 to EU GMP - Computerised Systems
5 shared controlsOWASP DevSecOps Maturity Model (DSOMM)
4 shared controlsNIST SP 800-171A Rev 3 - Assessing CUI Security Requirements
4 shared controlsDAMA-DMBOK2 - Data Management Body of Knowledge (2nd Edition)
4 shared controlsFDA Quality Management System Regulation (QMSR)
3 shared controlsUSMCA Chapter 19 - Digital Trade (United States-Mexico-Canada Agreement)
3 shared controlsBRCGS Global Standard for Food Safety Issue 9
3 shared controlsFrench Sapin II Law (Law No. 2016-1691)
3 shared controlsTraining on frameworks that overlap GAMP 5 - Good Automated Manufacturing Practice
There is no course on GAMP 5 - Good Automated Manufacturing Practice itself. These cover frameworks that share controls with it, so the material carries across even though the standard named is different.
Where GAMP 5 - Good Automated Manufacturing Practice overlaps with the standards you already hold
What an auditor will ask you for
All 11 GAMP 5 - Good Automated Manufacturing Practice controls, each with what it requires, the artefacts an auditor will ask you for, and where it commonly fails. Free to read, nothing to fill in.
Read the GAMP 5 - Good Automated Manufacturing Practice evidence request listWhat GAMP 5 - Good Automated Manufacturing Practice means in your sector
What GAMP 5 - Good Automated Manufacturing Practice means for your job
Questions people ask about GAMP 5 - Good Automated Manufacturing Practice
What is GAMP 5 - Good Automated Manufacturing Practice?
How many controls does GAMP 5 - Good Automated Manufacturing Practice have?
Where does GAMP 5 - Good Automated Manufacturing Practice apply?
What frameworks does GAMP 5 - Good Automated Manufacturing Practice map to?
How do I get started with GAMP 5 - Good Automated Manufacturing Practice compliance?
Query GAMP 5 - Good Automated Manufacturing Practice programmatically
GAMP 5 - Good Automated Manufacturing Practice, its 113 controls and every mapping into other standards are available over a REST endpoint and an MCP server, so an agent can read them directly. The free tier is 10 calls a day and needs no signup.
GAMP 5 - Good Automated Manufacturing Practice API reference and MCP config →What GAMP 5 - Good Automated Manufacturing Practice requires, control by control
Each page carries the requirement text for one GAMP 5 - Good Automated Manufacturing Practice control and what an assessor expects to see as evidence.
- 2ND-EDITION-AI-CLOUD-AGILE-CSA 2nd Edition (2022) - AI/ML, Cloud, Agile, DevOps and Computer Software Assurance (CSA)
- LIFECYCLE-VMODEL-URS-FS-DS-IQOQPQ V-Model Lifecycle - URS + FS + DS + IQ + OQ + PQ + Traceability
- RISK-CRITICALTHINKING Risk-Based Approach, Critical Thinking and 5 Key Concepts
- SOFTWARE-CATEGORIES 5 Software Categories (Appendix M4) - Infrastructure, Non-Configured, Configured, Custom
- SUPPLIER-OPERATIONS-CHANGE-PERIODIC Supplier Assessment, Operational Phase, Change Control and Periodic Review
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