GAMP 5 - Good Automated Manufacturing Practice S1: Appendix S1 Alignment with ASTM E2500

The guide aligns with the science- and risk-based approach of ASTM E2500 and related guidance so that the specification, design and verification of GMP manufacturing control systems focus on aspects critical to the patient and avoid the waste of commissioning equipment once and then repeating the effort in a separate validation. Combining good engineering practice, a science- and risk-based approach, process understanding and the involvement of subject matter experts, verification becomes one integrated body of work able to stand in for what used to be called installation and operational qualification, with regulated company qualification dropped, or reduced to reviewing what the supplier did and documented and closing any gaps, and performance qualification or verification focused on critical-to-quality attributes; a plan that sets out the approach and its rationale and a report providing the evidence are still produced. Where a computer-controlled system forms just one part of a larger manufacturing or process control system, it may need no validation of its own as a computerized system and verification is integrated with process validation, while IT systems outside manufacturing, such as clinical data, blood donor, adverse event, release and recall systems, have no parallel with process validation and are accepted on functional testing before controlled cutover. GAMP 5 follows the same principles: requirements clearly defined, critical-to-quality requirements identified with risks controlled, good engineering practice throughout, supplier testing leveraged as much as possible, and critical requirements checked, with results reported, by the regulated company. Organizations choose their own terminology, verification or qualification, and the guidance is neither mandatory nor prescriptive.