Risk Management Factors Related to Alternative Products (Availability), Inspection History, and GMP Compliance Status. Adapted from Rönninger, S.; Holmes, M. A risk-based approach to scheduling audits. PDA J. Pharm. Sci. Technol. 2009, 63(6), 575–588 (See Ref. 5).
| Sole Source or Alternatives | Inspection History | Compliance Status | Impact |
|---|---|---|---|
| Unique product in supporting market (local/global), no alternative products available for the approved clinical indication | Never inspected by any recognized competent authority/Last inspection: more than 5 years ago | Compliance status out-of-date or not known/Defects in the quality systems are definitely not known | Very High |
| Major product in supporting market (local/global), although alternative products for the approved clinical indication available | Last inspection: 3 to 4 years ago/Change in-site owner/Significant staff or product changes/Evaluation or information may be outdated | Compliance status could be affected by time or changes/Defects in the quality systems might not been known | High |
| More than one product in supporting market (local/global), alternative products for the approved clinical indication available, they may share the market | Last inspection: 2 to 3 years ago/Evaluation or information is not current | Compliance status has a good reputation by compliance history/Defects in the quality systems might be possible | Medium |
| Minor product in supporting market (local/global), alternative products for the approved clinical indication available and play major role | Last inspection: up to 2 years ago | Compliance status is good and has been assessed recently/Defects in the quality systems have been assessed and where necessary are being addressed | Low |