Change control
The quality-system process for proposing, assessing, approving and implementing changes that could affect a product’s quality or registration.
Under GMP, changes to processes, equipment, materials, suppliers or methods are assessed for risk and regulatory impact before they are made, and recorded in the quality management system. In the US, a moderate change needs a supplement filed at least 30 days before product made with it is distributed (21 CFR 314.70(c)).
Change control only covers the changes someone raises.
Where it goes wrong
Changes agreed informally between companies, or mentioned in a supplier’s cover email, are never raised, so they are never assessed.
What Spurby does
Flags change language in emails and minutes, ties it to the products affected, and asks quality to raise it. Approval stays in your quality system.
Spurby for pharmaOn our roadmap
Free template: Decision log template