Potential Impact Levels of the Category “History”
| Risk Level | Factor | Impact Assessment | Example Audits Conducted According Local and/or Global GMP Standards (e.g., PIC/S, WHO) |
|---|---|---|---|
| 4 | 6 | Compliance status out-of-date or not known or Defects in the quality systems are definitely not known | Never inspected by any recognized competent authority or Last audit: more than 5 years ago or Request for an Audit |
| 3 | 4 | Compliance status could be affected by time or changes or Defects in the quality systems might not been known | Last audit: 3 to 4 years ago or Change in-site owner (i.e., as a result of a merger, acquisition, or takeover) or Global reorganization or Significant staff or product changes or Evaluation/Information may be outdated |
| 2 | 2 | Compliance status has a good reputation by compliance history or Defects in the quality systems might be possible | Last audit: 2 to 3 years ago or Evaluation/Information is not current |
| 1 | 1 | Compliance status is good and has been assessed recently or Defects in the quality systems have been assessed and where necessary are being addressed | Last audit: up to 2 years ago |
Note: Inspections by internationally recognised “countries of reference” (e.g., any PIC or PIC/S member, EU member state, USA, Japan).