A formal change control system should evaluate every change that could affect the production and control of intermediates or APIs. Written procedures should cover identification, documentation, review and approval of changes to specifications, raw materials, test methods, facilities and support systems, equipment and computer hardware, process steps, labels and packaging, and software. GMP-relevant change proposals should be written up and approved by the units concerned and then by the quality unit. The potential impact on quality should be evaluated, a classification such as minor or major may guide the testing, validation and documentation needed, and scientific judgement should decide what additional studies justify a change to a validated process. When an approved change is implemented, all affected documents should be revised, and the first batches made or tested under the change evaluated. The potential effect of critical changes on retest or expiry dates should be assessed, if needed placing batches on accelerated or ongoing stability. Current dosage form manufacturers should be told of changes to established production and process control that can affect API quality.
The graph holds this control, the 0 it maps to, and the evidence behind each claim, over MCP and REST.