TABLE I

An Evaluation Scheme of Audit and Inspection Results for Sharing Knowledge (e.g., to Senior Management in Companies)

The Result of the Audit Was …	Good	Satisfactory	Unsatisfactory
Observations	An audit where none or only a small number of minor and isolated observations made regarding products, systems, or GMP requirement	An audit where isolated or potential non-conformances for products, systems, or GMP requirements were observed	An audit where systemic or major non-conformances or a large number of minor observations for products, systems, or GMP requirements were observed
Examples	Nonadherence to an internal procedure or requirement that has minimal impact on GMP and regulatory requirements and/or marketing authorisations. This can be resolved quickly or during the time the audit is conducted.	Noncompliances with GMP, regulatory requirements and/or marketing authorizations that individually are unlikely to directly or indirectly affect patient safety, product quality, efficacy, purity, integrity, or supply of the product, GMP, component, or service provided	Noncompliances with GMP, regulatory requirements and/or marketing authorizations that are very likely to directly or indirectly affect patient safety, product quality, efficacy, purity, integrity, or otherwise impact product, GMP, component, or service provided
Potential consequence	Areas of suggested improvement can be outlined. Supplier promotes continual improvement, risk management, and proactively manages compliance.	Supplier has to initiate remedial actions. Recommendations for improvement can be outlined. The supplier puts in place a timely remediation plan. Products can continue to be supplied in market.	Supplier has to initiate actions immediately if supply to the market is to continue. The audit observations may result in an immediate market action and/or pose a legal, regulatory, or business risk for the company and/or risk for the patient in terms of product availability in the market.