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Where required, the TGA will inspect manufacturing sites that are required to manufacture goods in accordance with Good Manufacturing Practice (GMP). Our target timeframes for these inspections are outlined in the tables below.
All timeframes are variable depending on the cooperation of manufacturers, sponsors and sometimes international regulatory agencies. We may not grant a licence or issue a certification until all deficiencies identified during an inspection have been resolved.
Target timeframes for manufacturing inspections
Our timeframes differ depending on whether the manufacturer is in Australia or overseas.
| Application type | Time period | Target timeframe |
|---|---|---|
| New Australian licence application | Effective♣ application to inspection scheduling | ≤ 2 months |
| Inspection scheduling to conducting inspection | ≤ 1 month | |
| Inspection to PIL (post inspection letter) | ≤ 1 month | |
| Inspection close out | Between 10 and 30 weeks * | |
| Variation to scope, premises or conditions of Australian licence not requiring on-site inspection | Effective♣ application to grant of licence | ≤ 3 months |
| Re-inspection of licensed premises | Inspection due date to inspection | ≤ 6 months |
| Issue of certificate: GMP certificate or notarised copy of licence | Effective♣ application to certificate issue | ≤ 15 working days |
- ♣: Time periods do not start until the application is 'effective' (i.e. application fees have been paid and all required documentation has been supplied);
- * Depends on inspection compliance rating
| Application type | Time period | Target timeframe |
|---|---|---|
| New GMP certification application | Effective♣ application to inspection scheduling | ≤ 5 months |
| Inspection scheduling to conducting inspection | ≤ 1 month | |
| Inspection to issuing PIL | ≤ 1 month | |
| Inspection close out | Between 10 and 30 weeks * | |
| GMP re-certification: re-inspection of compliant premises | Inspection due date to inspection | ≤ 6 months |
- ♣: Time periods do not start until the application is 'effective' (i.e. application fees have been paid and all required documentation has been supplied);
- * Depends on inspection compliance rating
Overview: GMP certification timeframes
Text version of Flowchart
- Application lodged
- Application free payment processed - within 2-3 days
- Application reviewed - within 4 weeks
Note: Time periods do not start until the application has been deemed effective by TGA (ie: all fees have been paid and all required evidence has been supplied)
- Inspection scheduling - within 12-24 weeks
- For certification: 8-16 weeks
- For licences: 2-4 weeks
- Onsite inspection conducted - within 4 weeks
- PIL issued
- Inspection closeout
- Inspection fee reconciliation - between 10-30 weeks
- Licence granted / GMP certificate or clearances issued
Version history
| Version | Description of change | Author | Effective date |
|---|---|---|---|
| V1.0 | Original publication | Manufacturing Quality Branch | August 2017 |